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Symposium Planned on Nasal High Flow

A Clinical Breakfast Symposium is being organized for the AARC congress on Optiflow Nasal High Flow Across the care continuum. The event is on October 15 from 6:30 to 8:15 a.m. At the Grand Hyatt Hotel in San Antonio, Texas. The presenter is Prof. Jean-Damien Ricard, Universitie Paris Diderot, and Hopitaux de Paris, and Dr Gonzalo Hernandez, from the Hospital Virgen de la Salud in Madrid, Spain. At the end of the session, people will be able to identify the current evidence for Nasal High Flow therapy, including mechanisms of action, evaluate the emerging and clinically significant applications for NHF therapy, and discuss the evidence regarding the use of NHF. CRCE credits will be available. For more details, contact your Fisher & Paykel Healthcare rep. Call (800) 446-3908 or email nasalhighflowevents@fphcare.com.

Mercury Medical Expands Team

Mercury Enterprises has announced that John Gargaro MD has joined the Corporate Board of Directors and Douglas Smith has joined the company as Vice President of Sales and Marketing. Dr. Gargaro is currently a board certified orthopedic surgeon and graduate of Harvard University and the University of Michigan Medical School. He is currently Chief of the Department of Orthopedic Surgery at Kaiser Permanente Colorado, former Chairman of the Department of Orthopedic Surgery and former Treasurer of the Medical staff at St Joseph Hospital, Denver CO. Industry experience includes consulting positions with Wright Medical and Johnson & Johnson/DePuy, as well as clinical research and speaker panel positions for Sanofi-Synthelabo Inc. and Organon Labs.

Douglas Smith's background includes 20+ years of sales and marketing experience with GE Healthcare, Dräger, Maquet Medical Systems USA and Siemens Medical Solutions USA, Inc. Mercury Medical, a veteran-owned medical products manufacturing and marketing organization, focused on airway management and anesthesia, is recognized by the industry as a leading provider of innovative airway management devices.

Life Support Ventilators Get Clearance

ResMed announced U.S. Food and Drug Administration (FDA) clearance of the iVAPS (intelligent Volume-Assured Pressure Support) therapy mode for its Astral life support ventilators. ResMed's award-winning, cloud-connected Astral ventilators are used for a range of respiratory conditions including chronic obstructive pulmonary disease (COPD), neuromuscular disease and restrictive thoracic disorder. iVAPS intelligently and automatically adapts to patients' changing needs by constantly monitoring their actual ventilation and respiratory rate in relation to their target ventilation and respiratory rate, and automatically adjusting pressure support as needed to accommodate each patient's unique needs, even as their disease progresses. "The iVAPS therapy mode has been one of the most requested enhancements to the platform," said Luke Maguire, president of ResMed's Cardio-Respiratory Care Global Business Unit. "Its introduction dramatically increases Astral's capabilities and gives pulmonologists, home medical equipment (HME) providers and others more flexibility." iVAPS is one of two key technologies within ResMed's IntelligentAir suite in the United States. The other is Intelligent Backup Rate (iBR), which provides backup breaths only when needed to give patients a chance to spontaneously trigger the ventilator.

New Study on Pulse Oximetry

Nonin Medical, Inc., the inventor of finger pulse oximetry, has announced the results of a new independent hypoxia lab study in humans that demonstrates that Nonin's PureSAT pulse oximetry technology captures and reports worsening patient conditions better than other Food and Drug Administration (FDA)-cleared oximeter brands. Nonin made the results available in a white paper at the American Thoracic Society (ATS) and American Telemedicine Association (ATA) conferences. In the study, conducted independently by Clinimark Laboratories in Boulder, Colo., three finger pulse oximeters were tested; one from Nonin Medical and two from large, private-labeled manufacturers. All oximeters had FDA 510(k) clearance as "medical devices," but two of them did not provide the clinical accuracy required to track desaturations in patients with low blood circulation and labored breathing. Only the Nonin Medical oximeter was able to accurately track the desaturation events as compared to an independent hospital tabletop oximeter control device. "Over the years, a number of inexpensive, imported FDA-cleared oximeters have flooded the market, all claiming to be accurate," said Jim Russell, vice president of quaIity, regulatory and clinical affairs for Nonin Medical. "This study dispels the myth that all pulse oximeters perform alike, especially on challenging patients such as those with chronic obstructive pulmonary disease (COPD).

Respected Educator Joins Passy Muir

Passy-Muir, Inc., the industry leader in tracheostomy education and manufacturer of the patented no-leak Passy-Muir Valve is honored to announce the appointment of Kristin King, PhD, CCC-SLP to the position of Vice President of Clinical Education & Research. Dr King comes to Passy Muir from the University of Tennessee Knoxville, where she was professor of Audiology and Speech Pathology. Her expertise is in cognitive-communication and swallowing disorders with medically complex patients of all ages, particularly those with needs secondary to traumatic brain injury (TBI), tracheostomy/ventilator, and pre-term birth. She has trained SLPs in FEES and VFSS and developed a program for SLPs in the management of patients on ventilators and the use of Passy-Muir Valves at a level-one trauma hospital. Dr King has published several peer-reviewed articles regarding evaluation and treatment of TBI, and regularly speaks to domestic and international audiences on the benefits and use of speaking valves, evaluation and treatment following TBI, and swallowing disorders. Dr King earned her PhD in Communication Sciences and Disorders from East Carolina University in 2008, and brings extensive experience as a college professor, published clinical researcher, and international speaker to her new position at Passy Muir. As a part of her responsibilities, Dr King will Chair Passy Muir's Centers of Excellence program, will act as Editor in Chief for Talk-Muir, will coordinate product related research, and work with the company's clinical education team to design and develop instructional programs and materials.

Spirometer Interface Announced

nSpire Health Inc and Meditab Software Inc have announced a new standardized HL7 interface providing pre-configured interoperability between AllergyEHR electronic health record and KoKo spirometers. This flexible solution interface offers many advantages to AllergyEHR and KoKo users:

  • A spirometry order is created from the IMS Visit.
  • The order with full patient demographics is available from any KoKo testing station.
  • All of the available KoKo spirometry tests can be performed, including FVC pre- and post-bronchodilator, challenge, and SVC testing.
  • Test results are automatically returned to the IMS Visit Note with a formatted text report, configurable PDF graphical report, and interpretation notes.

"In the Allergy, Asthma, and Immunology specialty, AllergyEHR has been rated the #1 EHR vendor by Black Book year after year. Partnering with KoKo enables us to keep delivering innovative solutions to our clients to meet the demanding and changing needs of their medical practice," says Manish Amin, Director of Product Development at Meditab. "This partnership helps our common customers make the most of their EHR and spirometry systems." Mary Burrell, Vice President of Global Sales at nSpire Health added, "There is an enormous demand for interoperability between our systems. We are coordinating the implementation efforts to ensure a seamless and quick customer implementation."

Japanese Approval Put in Motion

Respiratory Motion, Inc., in conjunction with their exclusive distribution partner, IMI Co., Ltd., Japan, received Japanese regulatory approval for their new ExSpiron 1Xi Minute Ventilation Monitor. Respiratory Motion, Inc. developer of ExSpiron, is the only patient monitor measuring non-invasive Minute Ventilation, critical for early identification of potentially life-threatening respiratory depression. Respiratory Motion's ExSpiron 1Xi was launched by IMI Co., Ltd. at the Japanese Society of Intensive Care Medicine at the February 11th-14th conference. The Japanese Society of Intensive Care Medicine (JSICM) was founded in 1974. Physicians joining the JSICM have specialized in intensive care with past experiences as anesthesiologists, emergency physicians, cardiologists, and pediatricians. The ExSpiron patient monitor provides non-invasive monitoring for Minute Ventilation, Tidal Volume and Respiratory Rate. Knowing a patient's minute ventilation, how much air they breath in one-minute, is essential to knowing their respiratory status. ExSpiron is the ONLY respiratory device to provide this comprehensive information for non-intubated patients enabling a more complete and quantifiable patient assessment throughout the care continuum. ExSpiron technology was first introduced to the Japanese market in 2015 in lectures given at several conferences by prominent physicians. Clinical research presented at JSICM overwhelmingly confirms that current respiratory monitoring using Respiratory Rate or EtCO2 is insufficient with potentially over 80% of Respiratory Depression events going undetected. Highlights of some of these six significant presentation include: * "Risk Stratification Using a Respiratory Volume Monitor" Late detection of respiratory depression (RD) in non-intubated patients compromises patients safety. Respiratory Volume Monitoring (RVM) can detect patients at risk for opioid-induced RD and/or experiencing post-operative apnea. * "Ventilation is a Better Assessment of Respiratory Status than EtCO2" EtCO2 measurements in non-intubated patients are unreliable so clinicians resort to using the respiratory rate (RR) measurements from the capnograph. Normal EtCO2 coincided with adequate RR just 24.9% of the time. Data demonstrated that relying on capnography to capture the respiratory status in non-intubated patients is lacking. * "Respiratory Rate is a Poor Assessment of Respiratory Status During and After Upper Endoscopy Procedures" Despite the use of capnography monitoring, incidence of low MV during routine endoscopic procedures was significant. Over 80% of all low MV episodes would not have triggered a low RR alarm. Conventional RR monitoring alone would fail to capture more than 80% of all low MV episodes. * "Assessing Ventilation in Patients Receiving Opioids" Monitoring respiratory rates as low as 6 breadths/min would still miss nearly 90% of Low MV episodes. * "Identifying Patients at Risk for Respiratory Depression" RVM can identify and quantify respiratory compromise in the PACU, ICU, or GHF. * "Respiratory Volume Monitoring Reduces False Alarms". Respiratory depression poses a significant threat to the safety of patients in Japan, where aging population and economic pressures have pushed hospital systems to embrace novel technology to eliminate preventable adverse events and contain cost. As in the United States, health care providers in Japan seek ways to identify patient risk before it becomes life-threatening. Repeated studies show the ExSpiron Patient Monitor is more effective than other technologies for identifying subtle changes in respiration that foreshadow life-threatening respiratory depression.

Pressure Controller Launched for Mechanical Ventilators

After successful FDA approval, Hamilton Medical is launching the IntelliCuff pressure controller in the US. Previously available as an option for the ventilator HAMILTON-G5, the innovative IntelliCuff technology has now been given its own housing. The ergonomic, hand held device is now available for use with all mechanical ventilators. The IntelliCuff pressure controller continuously measures and automatically maintains the cuff pressure during mechanical ventilation of adults, pediatrics, and neonates using a cuffed endotracheal tube or tracheostomy. This handy device ensures an optimal cuff pressure which increases patient safety. It also delivers cost savings and greater efficiency within daily routines in hospitals. It can be used in intensive care units, operating rooms and for inter-hospital transport. The leakage of oral secretions past the endotracheal tube (ETT) is a causative risk factor in the development of ventilator associated pneumonia1,2 (VAP), and excessive cuff pressure is a risk factor in tracheal injuries3. Continuously optimized and controlled cuff pressure supports ventilation therapy and protects patients. Hamilton Medical has developed IntelliCuff to make mechanical ventilation more efficient and, above all, safer. Existing solutions for endotracheal tube cuff pressure management require manual monitoring and adjustment of cuff pressure, which is a critical aspect of the ICU staff workload. It has been shown that up to eight manual adjustments of cuff pressure are required daily to maintain recommended cuff pressure ranges4. The cuff pressure controller of Hamilton Medical permanently maintains and measures the set cuff pressure with two sensors working independently. The device is designed for immediate use; no calibration is required. It operates in a wide but still safe range of desired cuff pressures for various cuffed endotracheal tubes to provide suitable solutions for various clinical situations. In critical situations, clinical staff can increase the cuff pressure for a user-defined period of time to secure the airway and avoid aspiration or unintended extubation; for example, in the event of vomiting, repositioning of the tube, or changes in patient positioning. Short-duration pressure increases—typical during coughing or retching—are tolerated by the device to maintain the self-sealing functions of high-volume low-pressure cuffs and to avoid needless alarms. To simplify a safe extubation, the IntelliCuff deflates the cuff on command. A large-scale display and convenient interaction buttons make adjusting and verifying settings easy. At all times, the important data is visible supporting an intuitive operation. IntelliCuff generates an alarm when a leaking cuff or disconnected tubing is detected, as well as in cases of excessive pressure, low battery, or a technical fault. When appropriate, it is also possible to silence some alarms while medical staff remedy the situation. The IntelliCuff disposable tubing is designed to fit the Luer connector on a variety of cuffed tubes. The shut-off valve prevents loss of cuff pressure in case of an accidental disconnection between the device and the tubing. For more information, check out a video here: www.youtube.com/watch?v=lA7-m7ohe3w

References

  1. Seegobin RD, van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. Br Med J (Clin Res Ed). 1984 Mar 31;288(6422):965-8.
  2. Lorente L, Lecuona M, Jiménez A, Lorenzo L, Roca I, Cabrera J, Llanos C, Mora ML. Continuous endotracheal tube cuff pressure control system protects against ventilatorassociated pneumonia. Crit Care. 2014 Apr 21;18(2):R77.
  3. Nseir, Saad, et al. Continuous control of tracheal cuff pressure and microaspiration of gastric contents in critically ill patients. Am J Crit Care 184.9 (2011): 1041-1047.
  4. Sole ML, Su X, Talbert S, Penoyer DA, Kalita S, Jimenez E, Ludy JE, Bennett M. Evaluation of an intervention to maintain endotracheal tube cuff pressure within therapeutic range. Am J Crit Care. 2011 Mar;20(2):109-17.
  5. Lizy C, Swinnen W, Labeau S, Poelaert J, Vogelaers D, Vandewoude K, Dulhunty J, Blot S. Cuff pressure of endotracheal tubes after changes in body position in critically ill patients treated with mechanical ventilation. Am J Crit Care. 2014 Jan;23(1):e1-8.

Firm Certified as a Veteran-Owned Business

Mercury Enterprises, Inc., dba Mercury Medical, Clearwater, Florida is verified and certified as a Veteran Owned Small Business (VOSB) by the U.S Department of Veteran Affairs, Center for Verification and Evaluation. Mercury Medical is a healthcare specialty organization recognized by the industry since 1963 as a leading provider of innovative airway management devices. As a Veteran Owned Small Business, Mercury Medical is included in the Veteran business database at www.vip.vetbiz.gov and eligible to participate in Veterans First Contracting Programs with the VA. For more information contact Mercury at www.mercurymed.com or contact by phone at 800-237-6418.

Critical Care Hospital Solutions Launched

Maquet Medical Systems USA announced the availability of its two new intensive care ventilators, SERVO-U, and its dedicated neonatal intensive care solution, SERVO-n. The launch of SERVO-U and SERVO-n marks the latest advancement in Maquet's longstanding leadership in mechanical ventilation and innovation with the SERVO brand. SERVO-U and SERVO-n were cleared by the U.S. Food and Drug Administration in December 2015. "SERVO-U and SERVO-n are quintessential Maquet products as each boasts our rich heritage in, and company-wide commitment to innovation in ventilation," said Raoul Quintero, President, Americas, Getinge Group. "Both ventilation platforms will allow us to bring additional, user-friendly support tools to clinicians at a time when care practice optimization is more important than ever. A clinician's ability to tailor ventilation to individual patient needs, through the intuitive user interface and the system's advanced capabilities like NAVA, is essential within the critical care environment. We believe that once our customers have tried SERVO-U and SERVO-n, they will never look at mechanical ventilators in the same way again." SERVO-U represents the next step to making protective ventilation more accessible, understandable and easy to implement, putting solutions at clinicians' fingertips to support the delivery of tailored patient care. At the foundation of SERVO-U is a completely touch-based interface that empowers users to manage ventilation in a highly intuitive and timesaving manner. The platform, which can be used on neonates through adults, supports efficient workflow in the fast-paced intensive care environment through on-screen, context-based guidance and clinical support tools that help facilitate the implementation of the various ventilation protocols. Available on each SERVO-U are innovative technologies such as NAVA® (Neurally Adjusted Ventilatory Assist) and Edi monitoring for enhanced patient-ventilator interaction and greater insight into patient respiratory condition. In addition to the solutions that SERVO-U brings to patients and clinicians, the platform is designed to grow with the customer. When patient needs change or new functionalities become available, SERVO-U can be upgraded easily and cost-effectively. The intuitive ventilation platform is the result of a comprehensive development process that involved collaboration with intensive care experts from around the world. The launch of SERVO-U marks the latest offering in Maquet Medical System's SERVO franchise which has been a longstanding leader in the global mechanical ventilation market.

Device Maker Finds Way to adapt

Passy-Muir (Irvine CA), the leading manufacturer of the No Leak speaking valve is introducing two adapters to provide clinicians with a way to easily connect the Passy-Muir Valve inline while the patient is mechanically ventilated. The adapters are designed to provide a secure connection between the Passy-Muir Valve and a tracheostomy tube, ventilator tubing, closed suction systems, or other adapters. Each adapter is latex free, color coded for easy identification, and provided in re-sealable, multiple unit packaging. The PMV-AD1522 is a step-down adapter to connect the PMV 007 (Aqua Color) to a T-piece type closed suction system. The flexible, PMV-AD22 adapter is designed to be used with the PMV 2001 (Purple Color). All Passy-Muir's products are proudly made in the USA. Both adapters will be available for purchase through Passy-Muir. In other company news, Passy-Muir recently released a new user-friendly app for iPhone and iPad designed to facilitate patient communication, provide valuable information regarding tracheostomy and foster patient participation in care. The app includes a number of useful features including: Pre-recorded responses & phrases which enable communication at a touch of a button, user-defined male or female voice, child voice option, attractive and intuitive menu, and custom phrase record option. Clinicians attending the 2015 ASHA conference may have caught a glimpse of some exciting revisions to the Toby Tracheasaurus pediatric program. The enhancements include new dinosaur cartoon characters, new therapeutic activity cards, and a clinically improved Toby Tracheasaurus Coloring & Activity Book that is sure to appeal to tracheostomized children, their caregivers and clinicians. Each Toby Tracheasaurus pediatric program kit comes with a draw-string backpack containing a Toby Tracheasaurus Plush Toy, the Toby Tracheasaurus Coloring & Activity Book with crayons, and a Toby Tote with an assortment of therapeutic toys. Featuring a pediatric tracheostomy tube and Passy-Muir Valve for the purpose of demonstration and education, the Toby Tracheasaurus Plush Toy provides therapists with a lighthearted method to introduce children to tracheostomy and the Passy-Muir Valve, while facilitating vocalization and enhancing therapeutic activities.

System Offers Better Suction

Ciel Medical, a medical device start-up focusing on unmet needs of those caring for the intubated patient, has announced the launch of the Sherpa Suction System, a tool to give nurses and respiratory therapists greater confidence in suctioning secretions pooling above the endotracheal tube's inflated cuff. Caregivers want to remove these mucus secretions to avoid aspiration into the lungs and the subsequent risk of acquiring ventilator associated pneumonia (VAP). The Sherpa Suction System is a single-patient product and includes the Sherpa Suction Guide and Suction Line. The Guide is a single molded unit that includes a locking feature, handle, soft tip and compatible with ETT sizes from 7.0 to 8.5 mm. Sherpa Suction Guide is easily clipped to the underside of the endotracheal tube and advanced until the handle is at the patient's teeth. The integrated Suction Line easily threads through the Guide, is advanced through the opening in the handle and guided to the optimal position for removal of secretions. The Sherpa Suction System allows for selective and cost-effective use of above-the-cuff suctioning in targeted patients.

Ventilation Device Addresses Transporting Neonates

The HAMILTON-T1 with neonatal option is a high-end transport ventilator that provides the best possible ventilation therapy for your smallest and most vulnerable patients. During transport, the HAMILTON-T1 delivers the same performance as a fully featured NICU ventilator at the bedside. Its unique features make it one of the best transport ventilators for neonates. Hamilton Medical has specially adapted the HAMILTON-T1 hardware and software to optimally meet the needs of ventilated neonates. Supporting tidal volumes of just 2 ml, the HAMILTON-T1 allows for effective, safe, and lung- protective ventilation for even the smallest preemies. The reliable and robust neonatal flow sensor accurately measures pressure, volume, and flow proximal to the patient. This guarantees the required sensitivity and response time, and prevents dead space ventilation. Therefore, the patient is better synchronized and the work of breathing (WOB) is reduced. The new neonatal expiratory valve can balance even the smallest differences in pressure and offers the neonate the possibility to breathe spontaneously in each phase of a controlled breathing cycle. In addition to all modern neonatal ventilation modes, the HAMILTON-T1 offers a new generation of nCPAP. In the new nCPAP-PC (pressure control) mode, you only define the desired CPAP target value for your patient and the ventilator automatically and continuously adapts the required flow to the patient's condition and possible leaks. Thanks to the demand flow technology, your patient will receive only as much flow as is necessary to obtain the set CPAP target. This reduces WOB, reduces the need for user interventions and ensures optimal leak compensation. You will also require less oxygen for transport and noise caused by the ventilator decreases distinctively. With approvals and certificates for most types of transport and situations the HAMILTON-T1 is an ideal escort for your tiniest patients, reliable everywhere, both inside and outside the hospital, in the air as well as on the ground. The built-in high-performance turbine makes it completely independent of compressed air, gas cylinders or compressors. This saves weight and space and even noninvasively ventilated neonates can be transported over long distances. The combination of a built-in and an optional hot-swappable battery provides a battery operation of more than 9 hours. This can be extended indefinitely with additional hot-swappable batteries.

RT Schools Given Ventilators

Draeger Medical, Inc. has made a large donation to help with the training of Respiratory Therapists. Draeger is a proud corporate partner of the AARC and offers leading innovations in respiratory care, including advanced ventilation modes, lung recruitment strategies and unique knowledge-based weaning programs, which will help to maintain cost-effectiveness and improve patient outcomes. Hospitals face enormous challenges attracting qualified Respiratory Therapists to meet the increasing demands placed on our health care system today. Institutions of higher learning that offer Respiratory Care education are on the front lines of training the next generation of dedicated Respiratory Care professionals. Broad training on modern-day mechanical ventilator products is essential to ensuring a new RT graduate is prepared to enter the workforce. During the AARC Summer Forum, Dräger was pleased to offer ten ventilators to Respiratory Therapy schools. These state-of-the-art devices were raffled off during the education section meeting, which addressed trends related to contemporary RT education. "Providing the latest technology in mechanical ventilation fosters a greater learning experience in the lab setting for RT students, and better prepares graduates for the workforce," said Ed Coombs, MA, RRT-NPS, ACCS, FAARC, director of marketing for Intensive Care & Neonatal Care, Draeger Medical, Inc.

Ventilator Circuit Stabilizer Launched

As many ventilator patients have become more mobile, both in long-term care centers and at home, increased safety has become an issue. One of the areas that is most important is to secure the patients ventilator circuitry and prevent accidental dislodgement. A more mobile patient, moving from bed to wheelchair and through everyday life, presents a unique challenge in not only providing proper ventilation but also in providing a safe method in securing the life sustaining ventilator tubing. In these critical moments of movement, the tubing and circuitry may easily find itself ensnared in bed sheets, on wheelchair railings or other hazards, which can result in serious injury or death from ventilator disconnections. Pepper Medical has introduced two products that will eliminate this issue and provide a safer environment for these patients. The first is the 701VCS (ventilator circuit stabilizer). The 701VCS is a harness style belt made of soft cotton laminate that fits comfortably around a patient's waist. Incorporated into the harness is a tubing securement strap that reliably secures the ventilator tubing getting it out of harms way and positioned close the patient's chest. The second product is the 701VCS/NG offering the same circuitry securement but also adds a second strap used to secure a nasal gastric (or oral gastric) tube keeping it secure and avoiding decannulation thereby reducing these difficult reinsertions. Find out more at www.peppermedical.com.

CF Award Announced

A $2.8 million agreement between Novoteris, LLC and Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, has been announced to develop an inhaled nitric oxide antimicrobial therapy for people with cystic fibrosis (CF) who have airway bacterial colonization. The Novoteris investigators' pilot trial in Europe of this therapy reported encouraging microbiological and lung function changes following two weeks of treatment in patients with CF. Gaseous nitric oxide's potent antimicrobial properties, lack of bacterial resistance, and its small molecule penetration capabilities could provide a promising alternative non-antibiotic approach to treating infections in people living with the disease. Novoteris expects to begin a Phase 2b study by Q3 of 2015 to be supported in part by this award from CFFT. CF is a rare life-threatening hereditary disease characterized by the production of thick, hard to clear mucus within the lung, leading to recurrent lung infections and loss of lung function. Antibiotic therapy, routinely used to treat lung infections in people with CF, becomes ineffective as bacterial resistance develops. The thick mucus within the lungs also makes it difficult for antibiotics to penetrate bacterial colonies so there is a great need to develop alternative agents that can treat bacterial infection in people with CF. Alex Stenzler, President of Novoteris, said: "Based on the success of our pilot trial, and the broad spectrum of bacteria and fungi that our product has demonstrated effectiveness against, we anticipate a high level of patient eligibility and interest for our Phase II efficacy trial. We are expecting that our program will provide a novel and the first inhalable gaseous antimicrobial agent for the treatment of patients with this devastating disease."

Instrumentation System Offers Flexibility

The Hans Rudolph, inc. has announced its SmartLab Instrumentation System. This is a flexible system for measurement and analysis of respiratory signals in research applications. The base module can accept up to three pressure sensor modules for measuring flow from pneumotachs and airway or other pressures. Optional inputs include an oximeter, CO2 sensor, temperature and humidity and digital I/O. The PC software provides real time graphs and calculations of many common respiratory parameters. Data can be saved for analysis or replayed. Custom software modules can be developed for special applications.

Electromed Invests in Smart Airway Technology

Electromed has announced the US market launch of its next generation SmartVest Airway Clearance System for acute care high frequency chest wall oscillation (HFCWO), the model SQL-I. The SmartVest SQL-I is designed to promote airway clearance, improve bronchial drainage and enhance mucus transport for patients with a wide range of pulmonary-related health conditions. The SmartVest SQL-I builds on Electromed's successful launch of the SQL System for homecare use in January 2014, by offering a device that is significantly smaller, quieter and lighter than previous versions. The system features enhanced generator programmability and adjustable RAMP, allowing clinicians greater flexibility to program patient specific HFCWO therapy protocols. The system also features a patented single-hose design, which eliminates multiple connection points, allows the patient greater freedom of motion and eliminates additional maintenance associated with hose cleaning. "The SmartVest SQL-I System represents Electromed's commitment to innovation by delivering market-driven HFCWO therapy solutions to physicians and their patients," said Kathleen Skarvan, Chief Executive Officer. "We designed the SmartVest SQL-I with unique features that set us apart from other HFCWO devices—plus innovations to help hospital staff provide the ultimate in therapeutically effective airway clearance therapy for adults and children." Additionally, the SmartVest SQL-I System features active inflate-active deflate and an open system design, which provides a more comfortable therapy experience by allowing patients to take deep breaths and breathe more easily without feeling restricted. The SmartVest System is sold into the homecare market for people with chronic lung issues, including bronchiectasis, cystic fibrosis and neuromuscular disease, and into the acute care setting for patients suffering from impaired airway clearance.

ResMed Provides Update on Study

ResMed has announced that SERVE-HF, a multinational, multicenter, randomized controlled Phase III trial did not meet its primary endpoint. SERVE-HF was designed to assess whether the treatment of moderate to severe predominant central sleep apnea with Adaptive Servo-Ventilation (ASV) therapy could reduce mortality and morbidity in patients with symptomatic chronic heart failure in addition to optimized medical care. The study did not show a statistically significant difference between patients randomized to ASV therapy and those in the control group in the primary endpoint of time to all-cause mortality or unplanned hospitalization for worsening heart failure (based on a hazard ratio [HR] = 1.136, 95 percent confidence interval [95% CI] = (0.974, 1.325), p-value = 0.104). The results from SERVE-HF are preliminary and will be submitted for future publication after further analysis. A preliminary analysis of the data identified a statistically significant 2.5 percent absolute increased risk of cardiovascular mortality for those patients in the trial who received ASV therapy per year compared to those in the control group. In the study, the cardiovascular mortality rate in the ASV group was 10 percent per year compared to 7.5 percent per year in the control group. There were no issues associated with the performance of the ASV therapy device in the trial. "Patient safety is our first and foremost priority. We have alerted and are working with appropriate global regulatory authorities about the safety signal observed in this study," said Glenn Richards, M.D., ResMed Chief Medical Officer. "The safety signal in SERVE-HF was observed only with the use of ASV therapy in people who have predominant central sleep apnea and symptomatic chronic heart failure with reduced ejection fraction. We are further analyzing the data to understand why this unexpected result was observed in this trial." ResMed is working with global regulatory authorities to proactively revise the labels and instructions for use for ResMed ASV devices to include a contraindication for people with symptomatic chronic heart failure (with left ventricular ejection fraction, LVEF, less than or equal to 45 percent). The company is also proactively informing healthcare providers, physicians, and patients of the cardiovascular safety signal observed in SERVE-HF. The safety signal observed in SERVE-HF was observed only with ASV therapy in patients with moderate to severe predominant central sleep apnea and symptomatic chronic heart failure with reduced ejection fraction. The study did not include people with central sleep apnea in the absence of heart failure. It is also important to note that SERVE-HF did not include any patients with predominant obstructive sleep apnea, and did not include any other treatment modality such as continuous positive airway pressure (CPAP) or auto-adjusting positive airway pressure (APAP). "SERVE-HF did not meet its primary endpoint, however this study provides valuable, practice-changing guidance on how to best care for people with chronic heart failure," said Prof. Martin Cowie, M.D., the co-principal investigator of the study and Professor of Cardiology at Imperial College, London. "SERVE-HF was a well-designed and executed study and because of it we now know that ASV therapy should not be used to treat central sleep apnea in people with symptomatic chronic heart failure with reduced ejection fraction." Healthcare providers and patients who have questions or would like more information are encouraged to call 1-800-478-9010 and visit www.SERVE-HFFAQs.com

Noninvasive Ventilators Introduced

ResMed has announced its Lumis series of noninvasive ventilation devices that combine personalized, simplified therapy with powerful wireless connected care capabilities. The Lumis series builds upon ResMed's legacy of innovation as a new option for patients with respiratory challenges who are not dependent on continuous ventilation. The Lumis series comprises the Lumis 100 VPAP S, Lumis 100 VPAP ST and Lumis 150 VPAP ST noninvasive ventilators that support a variety of therapy modes, built-in wireless connectivity, integrated humidification and intuitive simplicity that are the hallmarks of the series. Lumis ventilators are designed with a broad range of automatic settings making it an ideal choice for a wide variety of respiratory conditions and individual patient preferences. Lumis is the first ResMed ventilation platform with IntelligentAir, a collection of ResMed technologies that can tailor therapy to individual breathing needs, making truly personalized ventilation possible. The complete IntelligentAir suite for Lumis includes iVAPS (ResMed's unique volume-assurance therapy mode), iBR (an intelligent Backup Rate), and AutoEPAP (which maintains upper airway patency), as well as other features to personalize and fine-tune individual patient's synchrony and comfort (Vsync, TiControl, and trigger and cycle settings). ResMed engineers also kept comfort top of mind when designing Lumis: each device features built-in HumidAir heated humidification capabilities and the popular Climate Control Auto setting, which automatically determines optimal humidification by adjusting to ambient room conditions.

Pathway Cleared for Luna Devices

The FDA has given 3B Medical good news by giving 510(k) clearance for its new Luna Positive Airway Pressure (PAP) Device Platform. The Luna family of PAP devices is designed to offer patients the latest enhancements in sleep therapy while innovative compliance management technology allows for better patient management. The Luna sleep products offer more, free remote compliance reporting options than any other PAP device on the market. In a series of new innovations from 3B, the Luna brings both Wi-Fi wireless communication and QR Coding to sleep therapy. "Wi-Fi technology offers the ability to capture more data with greater efficiency, said Joe Toth, Vice President of Sales and Marketing. "Wi-Fi is typically faster, more reliable and, most importantly, absolutely free. With the continued developments in Wi-Fi technology and the ever growing need for more detailed and comprehensive data, we feel Wi-Fi is not only the better choice today, but tomorrow as well", said Toth. Luna also incorporates QR Coding. The ability to capture and immediately transfer compliance data through any smart device brings yet another unique innovation to the market. Luna integrates into 3B Medical's cloud based patient management system, iCodeConnect, which features Patient TouchPoint, a completely configurable, early intervention patient compliance coaching system. TouchPoint allows for clinicians to define individual protocols to allow them to more quickly and easily recognize potential issues with a patient's compliance. The Luna continues 3B Medical's efforts to increase patient compliance and restore profitability to the sleep marketplace by offering products that provide greater flexibility, functionality and efficiency at lower cost.

University Receives Donated Ventilator

A university received a valuable education gift recently when a Hamilton GALILEO ventilator was donated to Gwynedd Mercy University where the ventilator will be used exclusively for education purposes. "It will become a valuable component of our laboratory instruction for the sophomore and junior level of our program and as such will be inviting clinical faculty to the university to provide detailed in-service education program during the didactic and laboratory phase of our curriculum. It will allow us to enhance the mechanical ventilation module and will help us in educating aspiring respiratory therapist," according to William (Bill) F. Galvin, Program Director at Gwynedd Valley University.

Companies Locked in Battle

3B Medical, maker of products used in the treatment of obstructive sleep apnea, has filed a legal action in the US District Court for the Middle District of Florida, alleging antitrust violations by ResMed—specifically alleging that ResMed is "choosing winners and losers in the CMS competitive bidding process by preferential pricing," and has "created an environment of fear and bullying among customers," and "intentionally interfered in 3B Medical’s business relationships." In a statement from ResMed’s Global General Counsel, David Pendarvis, the company responded to 3B Medical’s allegations against ResMed: "There is no substance to the claims in the case. ResMed conducts business in an ethical and lawful manner. Physicians, customers, and patients prefer our products because they are better. We expect to win this case if it is brought to trial. We recently filed—and won—a case for patent infringement against 3B and its Chinese-based manufacturer, BMC Medical Co. The International Trade Commission agreed with us and found that BMC and 3B had infringed ResMed’s mask patents. In their complaint, 3B concedes they have had very limited success in the marketplace. Our business creates better lives for patients by designing, making, and selling high quality products that provide value for patients, customers, and healthcare systems. We maintain our focus on changing 20 million lives by 2020."

Acquisition Completed

Becton, Dickinson and Company has announced that it completed its acquisition of CareFusion Corporation. Vincent A. Forlenza, BD’s Chairman, Chief Executive Officer and President, said, "We are very excited to announce the consummation of the CareFusion acquisition, as it represents a major milestone in BD’s 118-year history. This acquisition significantly accelerates BD’s strategy and builds scale and depth in medication management and patient safety solutions. We look forward to the future with confidence as we become one of the largest global leaders in medical technology, and are better positioned to partner with healthcare providers around the world to provide safer, more economical and improved care." Excluding transaction-related expenses relating to the closing, BD expects the acquisition to have an immaterial impact on the company’s results of operations in the second fiscal quarter, which ends on March 31, 2015. The company will provide an update to its fiscal year 2015 outlook on its second fiscal quarter earnings conference call in May. Beginning in the second half of fiscal year 2015, BD will report a new Medical segment structure, which will include CareFusion. BD is a leading medical technology company focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology and respiratory care; advancing cellular research and applications; enhancing the diagnosis of infectious diseases and cancers; and supporting the management of diabetes.

Product Named to FDA List

The FDA has listed Kitabis Pak as a therapeutic equivalent of TOBI (tobramycin inhalation solution, USP) in their Orange Book. Kitabis Pak is listed with the AN designation meaning there are no known or suspected bioequivalence problems between Kitabis Pak and TOBI. "It makes sense that the FDA listed Kitabis Park as therapeutically equivalent in the Orange Book, because TOBI was developed as tobramycin inhalation solution delivered with the PARI LC PLUS nebulizer," said Jan Zimmermann, portfolio manager for Kitabis Pak at PARI. "One prescription for Kitabis Pak ensures access to both tobramycin inhalation solution and the PARI LC PLUS nebulizer handset, co-packaged and dispensed together. In addition, PARI initiated a compressor access program called PARI PROVIDE that is administered through a network of specialty pharmacies." The FDA approved the New Drug Application for Kitabis Pak on December 2, 2014. Kitabis Pak is a new standard for nebulized drugs where drug and nebulizer handset are co-packaged similar to asthma inhalers where the drug and device are prescribed and dispensed together. The price of Kitabis Pak is comparable to the price of generic tobramycin drug alone. "Our definitive goal is to ensure that patients with cystic fibrosis who are prescribed tobramycin inhalation solution also get the nebulizer handset that was used in clinical trials and approved for use with TOBI. Kitabis Pak accomplishes this goal and makes it easy for patients since they come together in an easy to understand kit," stated Lisa Cambridge, director of PARI's Medical Science & Pharmaceutical Alliances

Company To Aid Armed Forces

Zoll Medical Corporation, a manufacturer of medical devices and related software solutions, announced signing an agreement to buy substantially all of the assets of Impact Instrumentation, Inc., of West Caldwell, N.J., a manufacturer of respiratory care products. Impact Instrumentation has been designing and manufacturing portable and automatic emergency ventilators, portable and onboard aspirators, custom mounting systems, and specialized testing systems for over 35 years. Products include the Uni-Vent Series of portable critical care ventilators and portable resuscitators, and the Ultra-Lite Series of portable aspirators, which are used aboard ships, aircraft, and other military medical and transport services. The acquisition complements Zoll's comprehensive portfolio of lifesaving equipment for military applications, including monitors and defibrillators. Impact is the leading supplier of transport ventilators to the U.S. military. With the addition of the Impact Instrumentation product line, Zoll will now offer solutions to optimize circulation, cardiac rhythm, and ventilation when caring for critically ill patients, particularly those serving in the armed forces.

Mask Maker Touts CPAP Comfort Solutions

When it comes to CPAP masks, many of the models are nearly complete replicas of the other models. According to Hans Rudolph, its V2 stands out with unique features that leave other models behind. Unlike other masks on the market, the V2 does not use a hard plastic frame to mount the seal to. Instead, the V2’s seal and face piece are one molded piece of medical grade silicone. This allows for "unparalleled comfort at low and high pressures and at varying strap tensions." Where other masks cause skin breakdown, lasting marks and even bruising—forcing many patients to rip off the mask during the night or ditching CPAP completely—the V2 rests and complies to the face comfortably. When you think of a CPAP mask, you almost always picture the intrusive forehead support as well. The V2 proves that a full face mask doesn’t need this uncomfortable attachment in order to function properly. Instead of giving into the norm of the market, Hans Rudolph turned to its long history of quality engineering and design to solve this problem. A better mask with better seal technology and superior headgear use has allowed the V to be one of the only masks without a cumbersome forehead support. The headgear features five points of adjustment—four on the face piece connections and one Tri-Glide adjustment on the crown of the head. Achieving the right strap tension for a good seal is never a problem with the V2. Working your way to the front of the mask you will find that the V2 swivel port serves many functions as well. C02 ventilation, Anti-Asphyxia Valve, O2 titration ports and a detachment point can all be found on this Hans Rudolph port. For more information on the company’s line of products, visit www.rudolphkc.com.

imageInstrumentation Systems Offer Multiple Flow Ranges

Respiratory therapy products manufactuer Hans Rudolph is promoting its complete line of linear pneumotachs to respiratory therapy professionals looking to ensure their equipment has state-of-the-art quality operation. Included is the RSS 100HR Research Pneumotach Instrumentation system with Windows-based software for. Pneumotachs are available in eight flow ranges for small animals through exercising adults, with other features that include LCD display, auxiliary pressure input, gas calculator, linearization and data acquisition. The company also offers its PA1—Pneumotach Amplifier—a low-cost instrumentation module with analog outputs for flow and pressure or 2 flows or 2 pressures. It provides the instrumentation necessary to produce an analog output proportional to flow when connected to any Hans Rudolph standard Pneumotachs, which are available in 8 different flow ranges. The PA1 will also provide an analog output of an independent auxiliary pressure signal for pressure anywhere in the circuit. The outputs can be configured for different voltage ranges to ease connection of your data acquisition system. Offset and gain adjustment pots are available. Other products offered by the company include the Series 1101 Breathing Simulator, which models a spontaneously breathing patient based on a computerized mathematical lung model. Airway resistance, lung compliance, breath rate and patient effort are adjustable parameters that simulate a wide range of patient conditions. Includes a large LCD display with real time graphics and data acquisition capability. The Series 1120 Flow/Volume Simulator is a servo motor driven piston pump that can be used for testing spirometry products and other respiratory devices. It is designed to be used in product development and manufacturing test applications. The Flow / Volume Simulator operates in three modes. The exhale waveform mode is used to test spirometry devices using the ATS waveforms, peak flow waveforms or custom waveforms. The steady flow mode can be used to generate steady state flows over a wide range of flow rates. This mode can be used to test and calibrate flow meters. The breathing waveform mode can be used to produce a continuous inhale exhale flow waveform that simulates breathing. All of the modes provide graphs for the flow and pressure signals. Data collected during the test can be saved to a file for additional analysis. Built-in pressure sensors measure the barometric pressure and cylinder pressure during the tests. The pressure data is used to correct the calculated flow for gas compression. For more information on the company’s line of products, visit www.rudolphkc.com.

Michigan Lung Capacity Expanded

A new, sophisticated design modification from Michigan Instruments is expected to breathe new life into its Training and Test Lung—also known as the "Michigan Lung." The new design includes PneuView3, an innovative, intuitive software interface. The combination of the new software application and improved product design brings significantly improved user capabilities which further position Michigan Instruments as an innovative leader in the respiratory care industry. The new products will be available in July 2014. Developed 40 years ago, the Michigan Lung embodies a mechanical "respiratory simulation" of the human pulmonary system capable of measuring airway pressure, lung pressure, tidal volume and 36 other parameters. It is the most versatile, reliable lung on the market and the latest fully-to-scale mechanical design allows for simulation of hundreds of patient scenarios. The system is comprised of a precisely engineered mechanical test lung (or lungs), a set of electronic sensors, a signal conditioning package, and an integrated micro control unit. The PneuView3 software application calculates and displays, in real time, numerous respiratory parameters and waveforms. This data can also be exported for later review. Michigan Instruments says it complies with Food and Drug Administration (FDA) and International Organization of Standardization (ISO) regulations for Good Manufacturing Practices. Both the FDA and ISO systems require continuous control over all activities that assure the quality of Michigan Instruments products and services. More information is available online at www.michiganinstruments.com.

SleepVirtual Products Get Distribution Deal

A series of SleepVirtual products used in the diagnosis and treatment of sleep apnea, and sleep-related breathing disorders, will be marketed and distributed by MGC Diagnostics Corporation thanks to an exclusive agreement with Neurovirtual USA. According to a news release, the SleepVirtual BWII PSG and the BWIII PSG Diagnostic polysomnography systems will be handled by MGC in the US and Canada. The BWII has a small, lightweight design and may be used as a stationary unit or a portable unit (fitting into a small briefcase), providing flexibility to use one device in several locations. The BWIII is a larger device with combined sleep and neuro-diagnostics (EEG) capabilities.

B&B Adds to Team

B&B Medical Technologies announced that respiratory sales and marketing management veteran Stu Novitz has joined its team as the company expands its growing international presence and strengthens its distributor network. Novitz brings with him a wealth of experience working with distributors within the hospital homecare and long-term care market, having recently spent the last four years at Clement Clarke spearheading the company’s efforts to extend its reach into the North American medical markets. Joining in advance of B&B Medical’s new product rollout, Novitz will make an immediate contribution to the company’s continuing success. Novitz joins B&B Medical Technologies as Vice President of Sales and Marketing to advance B&B’s reputation for providing specialty airway solutions to clinicians worldwide. "I look forward to working with the management team to further define our action plans that will ensure B&B’s long-term growth strategy. I am fortunate to be joining such a respected company with enthusiastic goals for developing innovative, new products," said Novitz. B&B’s newest product on the horizon is a solution for the Neonatal Critical Care market and that is only the beginning—the company’s development plan is to launch new products each year.

Covidien a Guiding Light

Covidien has announced its support for the Centers of Medicare & Medicaid Services (CMS) guidance update emphasizing the need for post-operative electronic monitoring of patients receiving IV opioid medications, regardless of where they are located in the hospital. Opioids, frequently given to patients for pain management, may be associated with increased risk for dangerous complications from respiratory compromise, like respiratory depression, insufficiency, arrest or failure. The CMS updated guidance addresses the risk for respiratory compromise by urging hospitals to establish procedures for patient-risk assessment and appropriate electronic monitoring for earlier detection and prevention of oversedation and/or respiratory depression related to post-operative patients receiving IV opioids. Covidien said in a news release that it’s committed to raising awareness of the dangers of respiratory compromise and the need for continuous monitoring of patients across the hospital. In fact, the company recently launched an awareness campaign around this patient safety issue. Respiratory compromise is all too common, costly and deadly. HealthGrades data shows post-operative respiratory failure occurred in more than 17 of every 1,000 patients. The cost per respiratory failure event was more than $53,000, totaling $1.9 billion dollars in just the Medicare population. Proactive prevention of respiratory compromise, leads to better patient outcomes, reduction in cost and reduction in reactive rescues. The CMS guidance further highlights recommendations of expert organizations regarding post-operative opioid monitoring, with organizations calling for continuous electronic monitoring of oxygenation, respiration and ventilation of patients receiving opioids postoperatively through pulse oximetry, respiration rate and/or capnography. Covidien offers market-leading respiratory function technologies and a complete portfolio of monitoring solutions that can help hospitals meet APSF and ISMP recommendations—in particular by implementing a continuous electronic monitoring solution, including etCO2, respiration rate and SpO2, that is tailored to each patient’s unique needs.

AnchorFast Announced to Prevent Occlusion

Preventing occlusion just may have gotten easier as Hollister Incorporated announced the launch of the AnchorFast Guard oral endotracheal tube fastener with integrated tube protection. Recognizing the fact that every patient dependent on a ventilator is vulnerable and that ventilator-associated risks such as tube occlusions can result in increased length of stays and increased hospital costs, Hollister added this new product to the AnchorFast tube fastener line. Unlike separate bite blocks, the integrated tube protection sleeve is there before it’s needed, helping to prevent occlusion without interfering with routine care. "AnchorFast Guard provides the potential to improve patient outcomes and may increase efficiencies at the same time," said Timothy Goedvolk, RN, BScN. With the addition of integrated tube protection to the trusted securement system, the AnchorFast Guard tube fastener can help to bring a new level of confidence to the ICU.

Patent Invalidated

BMC Medical Co., Ltd says it has successfully invalidated a key ResMed patent on interfaces. BMC initiated invalidity proceedings in China against five ResMed's patents before the Chinese Patent Re-examination Board (PRB) in October 2013. The oral proceedings of five cases have taken place. One of the patents (No. 200680002169.4) entitled "Cushion for patient interface" has been revoked entirely by the PRB on April 22, 2014. Other cases are still pending. In addition, James Xu, President of BMC, also said that BMC was in the process of preparing similar IPR (Inter Partes Review) applications seeking to invalidate several ResMed patents in the US Patent and Trademark Office. Xu stated that BMC would initiate an "aggressive" new strategy with IPRs to invalidate a wide body of ResMed patents. "We did not ask for this fight, but we have no intention of backing down", said Xu.

New Name Turns a Corner for Chiesi

Cornerstone Therapeutics Inc., a specialty pharmaceutical company focused on commercializing products for the U.S. hospital and adjacent specialty markets, today announced an official name change to Chiesi USA Inc. following the completion of its acquisition by Chiesi Farmaceutici S.p.A. The acquisition, making Cornerstone a wholly-owned subsidiary of Chiesi, and this name change are the last steps in a process that began when Chiesi became Cornerstone's majority shareholder in 2009. "As Chiesi USA, we look forward to offering our patients and providers more benefits than ever before," said Ken McBean, President of Chiesi USA. "The additional resources made available by this merger will allow Chiesi USA to provide greater support for research and development initiatives while maintaining our commitment to the key therapeutic areas we serve. Being part of a global company also offers our employees additional opportunities for growth and additional support needed to build upon our success." Chiesi USA will continue to market its existing portfolio of products to the hospital and adjacent specialty markets and will actively pursue licensing and acquisition activities in these areas. Chiesi USA's headquarters will remain in Cary, N.C.

Bubbler Seals the Deal

B&B Medical Technologies has announced that the Bubbler Water Seal CPAP Valve is now FDA Approved. The company said that after working with focus groups and key opinion leaders, it had identified an enhanced feature set, which contributed to the design of a more convenient and versatile device for the clinical community. They designed the B&B Bubbler as they saw an increased demand for FDA-approved Bubble CPAP devices in the NICU. The B&B Bubbler can be used in neonatal critical care units, delivery rooms and special procedure units. A few of the top features and benefits include a dual-chambered design that allows fluid level to be observed without disrupting therapy, internal, drainable overflow chamber limits fluid to desired CPAP level, rotating CPAP dial and setting lock reduces risk of unintentional changes in pressure. Bubble CPAP has been around for over 30 years; however the first units were assembled by Respiratory Therapists in the hospital. Homegrown devices typically do not conform to today’s regulatory environment. The first FDA-approved bubble CPAP units came onto the market less than 5 years ago. B&B Medical Technologies’ goal is to develop innovative products that deliver positive outcomes, provide good patient care while addressing the need to control healthcare costs. The newest product solution is only the beginning – the company’s development plan is to launch a new product each year.

ResMed drops infridgement allegations against BMC and 3B

BMC Medical Co., Ltd. and 3B Medical, Inc. are pleased to announce that ResMed (RMD) has dropped one of the patents initially asserted against BMC and 3B, U.S. Patent No. 7,938,116 ("the '116 patent"), in the pending investigation before the U.S. International Trade Commission under Section 337. Following a ruling by the ITC's Administrative Law Judge restricting the scope of the asserted claims of the '116 Patent, ResMed voluntarily withdrew the patent from the investigation. The ITC confirmed that the '116 Patent was dropped from the case in a Notice issued on March 11, 2014. In addition, ResMed has confirmed that a number of the product designs introduced by BMC and 3B in the ITC investigation are not alleged to infringe its patents. The case is scheduled to go to trial on April 10, 2014. BMC and 3B will continue to aggressively defend against ResMed's allegations and look forward to a successful conclusion to the ITC's investigation. The current target date for the ITC to issue its final determination is December 23, 2014.

Maxtec announces new FLOCAP flow indicator

Maxtec, Salt Lake City UT, announces the release of our new FLOCAP flow indicator. The FLOCAP is a single-use CO2 & flow indication device designed for visualization of a patient's exhaled CO2 and expiratory flow. The CO2 indication will assist the caregiver in verifying proper ET Tube placement. The flow indicator helps the caregiver identify end of exhalation, which may help prevent breath stacking and its associated health issues during resuscitation. Contact Maxtec for a free sample. 800.748.5355 | www.maxtec.com.

Clear Sailing for Ventilator

Covidien, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, announced that its Puritan Bennett 980 ventilator has received US Food and Drug Administration 510(k) clearance. The new acute care ventilator from Covidien—designed to be simple, safe and smart—helps enable patients to breathe more naturally. According to Covidien, the most critical goal of clinicians is to get patients off mechanical ventilation as soon as possible. The Puritan Bennett 980 ventilator can help with a range of software capabilities, including its Proportional Assist, Ventilation Plus, and Leak Sync software, all designed to reduce the number of days on mechanical ventilation. Patients on mechanical ventilation are often sedated to ease agitation and help them tolerate breath support and other medical interventions. The Puritan Bennett 980 ventilator features advanced synchrony tools that help clinicians set the ventilator to adapt to their patients’ unique needs and help provide the appropriate level of support throughout the breath. The Puritan Bennett 980 ventilator system is designed for patients ranging from neonatal to adult. The ventilator system was also approved for commercial distribution in Japan and Canada and will be available in those countries and the US in the coming months.

Ventilation Cleared for MRI Setting

Ventilation specialists Hamilton Medical have announced they have received FDA 510(k) clearance for their Hamilton-MR1, a device that allows critically ill or injured patients to be ventilated even during MR imaging. The device covers a full range of clinical requirements such as: invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and non-invasive Ventilation (NIV). The Hamilton-MR1 can be used at the 500 gauss line, in the presence of either 1.5T or 3T magnets. In the MRI environment, where strong magnetic fields pose a danger for both the patient and the operator, safety is the highest priority. With the effectively shielded, MRI-compatible Hamilton-MR1 ventilator, ventilation performance and MRI quality is guaranteed throughout the procedure. The integrated TeslaSpy gaussmeter is programmed to alarm if the clinician places the device too close to the MRI magnet, which helps the clinician to properly position the Hamilton-MR1 at the 50mT (500 gauss) line or less. The Hamilton-MR1 can be used in ICU special care areas, cardiac surgery recovery rooms, step-down or sub-acute care units, and when transporting patients to the MRI-department. In these cases, the device guarantees uncompromised, continuous ventilation care from the ICU to the MRI and back with its 6-hour battery life. Alternatively, the device can be used as an MRI-proprietary ventilator, waiting in the MRI department for the patient. In the MR environment – when the clinician is unable to stay close to the patient for routine adjustments—the ASV mode will automatically adapt to the patient’s lung condition. Positioning a medical device too close to the MRI can have fatal consequences and cause serious injury to the patient or clinician. In addition, significant financial losses can occur if a shutdown of the MRI is required. The Hamilton-MR1’s integrated gaussmeter continuously monitors the magnetic field and gives the clinician both an audible and a visual signal if the device is getting too close to the MRI magnet. For increased MRI safety and ease of use in the MR environment, the integrated gaussmeter continues monitoring—even when the ventilator is not in use. Close proximity of the ventilator to the MRI machine is crucial. The Hamilton-MR1 includes a trolley made out of non-ferrous materials, which will not be attracted to the powerful electromagnetic forces emanating from the MRI’s magnet. The trolley also has a "fail-safe" braking system.

Company Licenses Its Technology

Irish respiratory drug delivery company Aerogen announced it had capped off an "incredible" 2013 and set a new path for 2014 by signing a technology access and licence agreement with Philips, which also includes the acquisition of select assets solely related to Aerogen’s home-care business. This transaction will allow Aerogen to focus on its corporate strategic goal to expand its leadership position in the respiratory drug delivery acute-care and home-care ventilation settings.  The deal consists of an initial upfront payment with further royalty income based on exploitation of the  licensed technology. Further details of the transaction were not disclosed, but Aerogen said the deal would allow it to focus on expanding its core business in the acute care setting. Aerogen was honoured in 2013 with the prestigious Zenith Award from the American Association of Respiratory Care (AARC) in November and went on to win the Medical Technology Company of the Year Award presented by the Irish Medical Device Association (IMDA) in December. Both Aerogen and Philips said they are committed to ensuring that the transaction will enhance the supply of products and services to their respective customers. Aerogen’s acute-care and home ventilator drug delivery business is unaffected by the transaction and no employees will transfer to Philips.

Path Cleared for Airway System

The next generation of airway clearance systems has been cleared for market by the US Food and Drug Administration. Electromed, Inc., a global medical device company, announced it received notification that its Airway Clearance System, the model SQL has been cleared to market. According to Eletromed, in addition to being significantly smaller, quieter, and lighter than its previous versions, some of the features include enhanced ramping, an enhanced pause feature and more user-friendly graphics. The model SQL is an electrically powered precursor device designed to deliver high-frequency chest wall oscillation to promote airway clearance, improve bronchial drainage and enhance mucus transport under the order of a physician’s prescription. It is prescribed to patients with a wide range of pulmonary-related health conditions, including bronchiectasis, chronic obstructive pulmonary disease, cystic fibrosis, muscular dystrophy, and cerebral palsy. HFCWO has been demonstrated to reduce lung infections and reduce health-care costs associated with recurrent pneumonias, antibiotic use, and hospital stays. In addition to the innovative SQL generator, the system boasts a lightweight soft-fabric garment with several patented features. More info at Electromed.com.

Line of CPAP masks cleared for launch

A line of CPAP masks from 3B/BMC has been approved by the US Food and Drug Administration to be launched on the market. The iVolve family of CPAP interfaces rounds out 3B/BMC’s CPAP mask offering with a new premium, ultra lightweight and comfortable line of interfaces. The iVolve mask line has dual soft silicone lining for added comfort, and extremely quiet ventilation. The iVolve line of mask consists of the N2 Mini-Nasal, Nasal and Full Face Mask. Market launch on the iVolve series of masks is scheduled for February 2014. More info at 3Bproducts.com.

Enhanced Care

Hill-Rom Holdings, Inc has commercially released the MetaNeb 4.0 System, the company's latest advancement in airway clearance technology for enhanced patient care in the hospital.  Delivering therapy through airway oscillation (Continuous High Frequency Oscillation) and continuous pressure (Continuous Positive Expiratory Pressure), the MetaNeb 4.0 System helps enhance normal mucus clearance from the lungs, delivers lung expansion therapy, and assists in the treatment and prevention of pulmonary atelectasis, a complete or partial collapse of the lung. The system also has the ability to provide supplemental oxygen when used with compressed oxygen. The next-generation MetaNeb 4.0 System improves therapy performance, enhances ease of use when used with mechanical ventilation, and enhances therapy delivery. Patients who may benefit from the MetaNeb 4.0 System include those with one or more of the following disease states: bronchiolitis, cystic fibrosis, asthma, chronic bronchitis, neuromuscular disorders, emphysema, COPD, patients needing post-operative airway management, and patients needing emergency room airway management. Contact www.hill-rom.com.

A Major Leap

Respiralogics’ new baby line represents a major leap forward in the delivery and maintenance of nCPAP and non-invasive ventilation for infants in the NICU and PICU by providing comfortable, secure and skin-friendly fixation. Clinicians’ experiences and critical eye were integral in the design and development of the baby products, which were developed after listening to many a clinician’s frustration with current products. The new Respiralogics line includes: Baby Nose Bumper and Circuit Bumpers  for the baby who Just Wants To Have A Pretty Nose after therapy is complete. The skin-friendly Baby Nose Bumper "mustache" is made of RespiraGel, Respiralogics’ new hydrocolloid- based adhesive. Baby Nose Bumper gently holds the nasal interface to the mustache-area, providing a secure grip and gentle cushion for the nares. Circuit Bumpers provide a cushion for the breathing circuit by gently attaching the inspiratory and expiratory limbs to the Baby Cap. Baby Nose Bumper and Circuit Bumpers allow ideal fixation and comfort of the patient interface. Baby Cap is for the baby who Just Wants A Soft, Comfortable Cap. Baby Cap holds the nasal prongs and circuit in place, providing optimal fixation for infant nCPAP and NIV. The inspiratory and expiratory limbs are secured to the Baby Cap with Circuit Bumpers. Baby Chin Strap is for the babies who Just Can’t Keep Their Mouth Closed. Baby Chin Strap is a single patient use device intended to help keep small patients’ mouths closed during delivery of nasal CPAP and NIV. Baby Chin Strap provides support with a soft, skin-friendly strap placed under the chin and secured to the Baby Cap with hook and loop tabs. Baby Chin Strap is a comfortable solution for mouth leaks. It adjusts to provide the support needed to easily close the mouth. [RespiraGel, Baby Cap, Baby Nose Bumper and Baby Circuit Bumpers and Baby Chin Strip are trademarks of Respiralogics.] Contact respiralogics.com.

Approval

Bunnell Life Pulse High-Frequency Ventilator (HFV) circuit has been under a Class 1 Recall since December 12, 2013. With the approval of a new circuit for the Life Pulse HFV, Bunnell can now recall and replace circuits in the field that were included in the Class 1 Recall. Letters were sent to all affected hospitals announcing the circuit recall, identifying the affected Lot#’s, and explaining the return and replacement procedure. The new Life Pulse circuits have a heater wire with insulation that has a much higher melting temperature than the original heater wire. As a result, the failure mode that initiated the recall is eliminated. Bunnell Incorporated has been in business since 1980 and has manufactured the Life Pulse HFV since 1988. Contact bunl.com.

Medal Winner

Fisher & Paykel Healthcare was recognized recently for Optiflow Junior, its new nasal cannula designed specifically for infant and pediatric patients, with a silver award at the prestigious Medical Design Excellence Awards. The award was presented in Philadelphia and is further recognition of the company’s customer-led design processes. The Medical Design Excellence Awards (MDEA) are the medical technology industry’s premier global awards and are judged by a multidisciplinary panel of independent jurors comprised of a balance of clinicians, engineers, and designers. Optiflow Junior was first released to market in March 2012 following years of engineering and development which included significant in-hospital customer research. Optiflow Junior is a revolutionary system for providing simple and effective delivery of oxygen therapy to infants in respiratory distress, and combines an anatomically contoured nasal cannula with optimally humidified flow. It is a high performance product that responds to requirements from parents, nurses and doctors—flow delivered through soft anatomical prongs, ease of use with a patented Wigglepad system which enables easy re-application, adjustment and maintenance, and longer circuits and a clothing clip that enables improved mother child bonding and feeding. The result is a cannula that is loved by clinicians, parents and babies. Contact www.fphcare.com.

Gift Of Life

The LIFE Corporation manufactures superior quality, patented Emergency Oxygen and CPR Administration equipment that is lightweight, portable and easy to use for all kinds of emergency first aid situations. The products from LIFE are the only models currently on the market that offer both the 6 and 12 LPM flow rates with just two simple settings, "norm" and "high." The LIFE StartSystem is packed inside a durable, water-resistant case that weighs only 8 pounds, and has the capability to hold both an AED defibrillator along with equipment for administering emergency oxygen. Containing a 15+ minute supply of 113 liters of safe, stable oxygen that does not expire and can be given in all temperatures, the oxygen cylinder additionally features a constant reading supply gauge to check oxygen levels, even when the unit is not turned on, and a durable, knurled knob valve for easier operation. The StartSystem easily fits into a standard-sized AED wall cabinet, and spare oxygen cylinders are optional, or the empty cylinder can also be refilled at a certified gas distributor. The defibrillator is sold separately. Available in two different models, the LIFE SoftPac system is the preferred choice for frequent carrying as it weighs only 6 pounds. Model LFC-LIFE-2-612 features the FDA minimum setting of 6 liters per minute for general emergencies, and the American Heart Association's 100% inspired oxygen at 12 liters per minute for extreme emergencies. The LFC-LIFE-2-025 model is recommended for trained EMTs, and features a variable flow rate with twelve independent flow settings for a wide range of emergencies. Both models contain a 40 minute supply of oxygen when they are set at 6 LPM, and the constant reading gauge allows monitoring of the amount of oxygen remaining in the unit. The LIFE CPR Masks can also be purchased separately in cases of 20, with a large airway opening that relieves back pressure, and a seal created by contoured soft medical-grade PVC. The one-way valve helps to prevent transfer of contagious diseases, while the hydrophobic 3M Filtrete filter located above the valve assists in preventing cross-contamination. These universal-fit masks are clear to enhance visual observation of the mask's interior, as well as the patient's status and color. Contact www.lifecorporation.com.

Updated Website

Electromed, Inc, maker of the SmartVest Airway Clearance System, is pleased to announce the launch of its updated website: www.smartvest.com (also located at www.electromed.com). The new site is designed to assist patients, clinicians, and payers in making well-informed decisions regarding High Frequency Chest Wall Oscillation (HFCWO) and the SmartVest Airway Clearance System, while reflecting the new look of the Company’s brand. In addition to a refreshing new design, updated features include: • Improved navigation—will allow visitors to quickly find the information they need to access. • One-click access to prescription forms—immediately directs clinicians to the material they need to order the SmartVest System. Electromed, Inc manufactures, markets, and sells products that provide airway clearance therapy, including the SmartVest Airway Clearance System, to patients with compromised pulmonary function. For further information contact electromedcom or call (800) 462-1045.

Take A Breath

Dräger announces the launch of an innovative new interactive community for respiratory care professionals. Called "A Breath Ahead," the portal provides continuing respiratory care education, along with the ability to interact with peers, academics, researchers and clinicians. Respiratory care professionals can participate in forums, polls, and discussion groups, exchanging information and ideas with peers and experts in the field. Participants can earn complimentary Continuing Respiratory Care Education (CRCE) credits online through the educational component of the portal. The interactive portal is being launched at the AARC Congress being held in New Orleans, Louisiana on November 10-13, at Draeger’s booth #1000. Developed in collaboration with leading clinicians and educators, "A Breath Ahead" website enables respiratory care professionals to tap into the expertise of clinical experts and opinion leaders to discuss topics such as protective lung strategies, evidence-based best practices, neonatal/pediatric issues, and other relevant topics. Clinicians can earn complimentary CRCE credits online, without the expense and time required to attend classroom educational meetings. Providing a forward-looking approach to clinical education, this unique portal is interactive and provides valuable information and education at the convenience of the clinician’s schedule. "A Breath Ahead" includes educational webinars, interviews with key opinion leaders, case studies, and FAQs. The interactive portal also provides a forum for respiratory professionals to interact with peers and opinion leaders. Participants can also take part in polls and surveys on topics of interest and concern for the respiratory care profession. Contact draeger.com/abreathahead.

Stay Safe

Mercury Medical has introduced the Flow-Safe II Disposable CPAP System for emergency care, which offers over 50% less oxygen consumption, with high FiO2 delivery, which is a major advantage for long transport, and uses standard flowmeters. The lightweight contoured mask provides a better seal, while the nylon headpiece and quick release front clips maximize patient comfort. Its built-in manometer and pressure relief valve verifies consistent delivered CPAP pressure. It requires no assembly of separate apparatus, and the pressure relief valve automatically adjusts to avoid excess pressure. The nebulizer, with in-line capability, allows administration of meds without mask removal. Contact (800) 237-6418, mercurymed.com.


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