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Respiratory Treatment Options Receives FDA Clearance

Monaghan Medical Corporation announced the newly approved combination for two of its groundbreaking products—the Aerobika oscillatory positive expiratory pressure (OPEP) device and the VersaPAP positive airway pressure device—to create a low cost, safe and effective “tandem therapy” which allows clinicians to treat a variety of pulmonary conditions requiring lung expansion and airway clearance. Lung expansion therapy is designed to prevent or treat atelectasis—the complete or partial collapse of the lungs—and can also reduce air trapping on exhalation caused by conditions such as asthma or chronic obstructive pulmonary disease (COPD). The overall goal of this tandem therapy is to improve lung volumes by maximizing lung re-expansion (alveolar recruitment) while optimizing airway clearance. The combination of Aerobika OPEP and VersaPAP devices allows for an efficient and effective synergy when used in tandem, optimizing the function of each. Augmentation of maximum flow from the VersaPAP device creates airway expansion on inhalation, allowing for the patient to take in a larger breath. This, in turn, means the patient will have more air to exhale. Oscillations from the Aerobika OPEP device are then maximized on exhalation to improve airway clearance and further lung expansion by the added resistance of both devices. This results in patients receiving positive pressure on inhalation and exhalation, simultaneously optimizing lung expansion and airway clearance. Tandem therapy is yet another added value to a complete system of care for respiratory ailments. The Aerobika OPEP, VersaPAP device, and AeroEclipse II Breath Actuated Nebulizer (BAN) can be used individually or in a variety of combinations to efficiently and effectively treat a patient’s pulmonary condition, and easily adjust therapeutic regimens as a patient’s condition changes. This “plug and play” model is not only cost effective, but also a true benefit to patients in a hospital setting and as they transfer to a residential setting.

Multicenter Study Evaluates Trend Accuracy of Noninvasive, Continuous Masimo SpHb and Two Invasive Hemoglobin Testing Methods

Masimo announced that in a multicenter study recently published in the Journal of Clinical Monitoring and Computing, researchers at three institutions – Loma Linda University in California (LLU), the University of California at Irvine (UCI), and Mayo Clinic in Jacksonville, Florida (MCF) – evaluated the trend accuracy of three hemoglobin (Hb) monitoring methods, including noninvasive, continuous Masimo SpHb.

 

Dr Applegate and colleagues prefaced their investigation by noting that Hb measurement "informs patient-specific perioperative transfusion decisions within the context of symptoms, comorbid conditions, surgical procedure, observed bleeding and hemodynamic performance." They also noted, however, that "the time needed for blood sampling and analysis can cause Hb measurement to lag clinical situations. In surgical settings in which blood loss may not be apparent or be difficult to estimate, continuous rather than intermittent Hb monitoring could provide earlier warning of decreasing Hb." Thus, they sought to determine whether noninvasive, continuous hemoglobin monitoring using Pulse CO-Oximetry (SpHb) might provide useful real-time information about changes in Hb.


The researchers compared noninvasive SpHb measurement and two invasive methods of determining intraoperative Hb changes – arterial blood gas CO-oximetry (ABGHb) and point-of-care hemoglobin using arterial blood (aHQHb) – to laboratory determined hemoglobin changes (tHb) for trend accuracy. SpHb was measured using Masimo Radical-7 Pulse CO-Oximeters with rainbow fingertip sensors at all sites. Based on the institution, ABGHb was measured using either a Radiometer ABL800, Nova Biomedical CCX or PhOX, or Siemens RAPIDLab 1265; aHQHb was measured with a HemoCue HB 301; and tHb was measured using either a Sysmex XE5000 or Coulter AcT-diff or LH 750, also depending on the institution.


The researchers independently enrolled 135 adult patients undergoing non-cardiac surgery in which arterial catheterization was planned and repeated intraoperative blood gas analysis was expected (51 at LLU, 26 at UCI, and 58 at MFC). During surgery, whenever arterial blood analysis was performed, SpHb (as displayed at the time blood was drawn) was recorded, and samples were analyzed within ten minutes using ABGHb, aHQHb, and tHb. On average, patients had 4 samples obtained (ranging from 2 to 13), with a total of 551 blood gas samples analyzed, providing 416 sequential changes in Hb for trend assessment.


Using modified Bland-Altman analysis, the researchers assessed trend accuracy for the three methods compared to laboratory analysis, calculating mean bias (95% limits of agreement) of 0.10 (-1.14 to 1.35) for SpHb, -0.02 (-1.06 to 1.02) for ABGHb, and 0.003 (-0.95 to 0.95) for aHQHb. Defining a change in SpHb, ABGHb, or aHQHb as ± 0.5 g/dL and a change in tHb as ± 0.25 g/dL, the researchers found that changes in direction agreed with tHb changes in direction as follows: in 94.2% (88.9-97.0%) of SpHb changes, in 98.9% (96.1-99.7%) of ABGHb changes, and in 99.0% (96.4-99.7%) of aHQHb changes.


The researchers concluded, "We found that SpHb, ABGHb and aHQHb changes more than ± 0.5 g/dL have similar correlation to the direction but not necessarily the magnitude of tHb change during surgery. The similar agreement in trend direction suggests that clinicians can choose which to use based on availability or preference, although continuous SpHb monitoring may provide useful ongoing Hb trend information. Continuous noninvasive SpHb decreases exceeding -0.5 g/dL may prompt a decision to obtain a confirmatory tHb measurement if low tHb is clinically suspected, but not replace blood Hb measurement in guiding transfusion decision making."


Comparing their results to two previous single-center studies involving changes in SpHb compared to changes in tHb, the researchers noted that their multicenter study produced “similar” results in both cases: one study (of volunteers) found 95.4% SpHb change agreement in 22 samples with tHb < 10.0 g/dL, while the other study (of 70 trauma patients) reported bias of -0.05, with limits of agreement of -0.62 to 0.51.


SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition and laboratory diagnostic tests using blood samples.

Study Says This Device is ‘Feasible’

Vapotherm, Inc., a global medical technology company focused on the development and commercialization of its proprietary Hi-VNI Technology, announced that a paper published in the Journal of Clinical Respiratory Diseases and Care, titled “Assessing the Clinical Effect of High Velocity Nasal Insufflation on Improving Ambulation in Patients with Dyspnea: A Feasibility Study” demonstrated that use of Vapotherm Hi-VNI Technology during ambulation is feasible and showed that patients with dyspnea participating in this study who used Hi-VNI Technology as respiratory support walked farther and recovered faster when compared to standard oxygen treatment. “These results show that the Vapotherm Transfer Unit not only provides support for hospital transfers across all deparments, but also offers an important respiratory support option for clinicians managing inpatients requiring ambulation as part of their treatment,” said Joe Army, President and CEO of Vapotherm. “This study offers an additional proof point for clinicians that Hi-VNI Technology may help their patients, not just in general settings as Mask-Free NIV for spontaneously breathing patients, but also during ambulation and recovery.” The feasibility study was a prospective cross-over trial that compared oxygen treatment as usual (TAU) to treatment with Hi-VNI Technology—which delivers high velocity nasal insufflation (HVNI)—in 28 patients during ambulation in both inpatient and outpatient settings. The goal was to compare how far and for how long patients could ambulate on Hi-VNI Technology versus the standard TAU. Vital signs and recovery time were measured as secondary outcomes. 25 of the 28 patients were analyzed. Among the inpatients in this study, Hi-VNI Technology during ambulation was not only feasible, but also showed improved patient distance walked by 12.4% and duration of time walked by 8.5%. It also improved recovery time by 32.5%. Use was also feasible among outpatients undergoing ambulation, although outpatients performed worse than the inpatient subgroup studied. These results are very encouraging for further research as well as demonstrating feasibility of using Hi-VNI Technology in respiratory patient ambulation. While this study was comparing Hi-VNI Technology to oxygen support, previous studies have demonstrated that Hi-VNI Technology is comparable to noninvasive positive pressure ventilation (NiPPV) when treating patients in undifferentiated respiratory distress. The Vapotherm Transfer Unit is a self-contained mobile means of delivering Hi-VNI Technology for patients on the move in the acute setting.

Companies Announced Distribution Partnership

A “monumental distribution partnership” has been announced between Pharma Systems and CAREstream America. Pharma System manufactures the humidification and filtration products that you currently purchase. CAREstream America, based out of Orlando, Florida, offers a variety of premium product and therapy solutions for Aesthetics, Anesthesia, Pain Management, and Respiratory care specialties across the US. Effective January 1, 2020, CAREstream America will become the exclusive distributor of Pharma Systems products in the US. To ensure a seamless transition, the existing product numbers, terms and prices will stay the same. To place an order now with CAREstream America, email orders@carestreamamerica.com, or fax your request to 407-960-2758. If you have any questions, please reach out to our main office at 855-892-3872 or info@carestreamamerica.com.

‘Breathing Company’ gets FDA Clearance

Vyaire Medical, Inc., the healthcare industry’s dedicated “breathing company,” announced the US Food and Drug Administration (FDA) has granted FDA 510(k) clearance for two of its latest Pulmonary Function Testing (PFT) technologies: Vyntus ONE, Vyntus BODY with SentrySuite Software. The Vyntus ONE is designed to be a convenient PFT station available in a fixed or mobile configuration that is patient-friendly and easy for clinicians to use. Vyntus BODY is engineered to conduct body plethysmography to measure lung capacity and other pulmonary functions for patients of all sizes and mobility, offering larger interior space to accommodate patients of any size without increasing the footprint of the cabin. Both Vyntus ONE and Vyntus BODY include a newly designed Ultrasonic Flow Sensor that represents significant improvements in efficiency and accuracy of pulmonary function testing. All Vyntus technologies run on the SentrySuite Software, which is easy-to-operate and designed completely around the user experience for accurate results and optimal workflow. SentrySuite provides seamless integration and secure connectivity with both the clinical infrastructure and the electronic medical records (EMR) platform. “These new Vyntus products offer a modern ergonomic design, state-of-the-art ultrasonic sensor technology for consistent and accurate respiratory testing as well as more efficient hygiene and maintenance protocols for customers.” said Dave Eckley, Vyaire’s Chief Executive Officer. “These benefits are absolutely meaningful in today’s respiratory diagnostics clinical environment and demonstrate the value of the Vyaire technologies.” Vyaire believes this product launch represents the most progressive innovation in the Respiratory Diagnostics field in many years. Vyntus ONE and Vyntus BODY are the continued expansion of the portfolio – including Vyntus CPX, Vyntus SPIRO, Vyntus WALK, and VyntusTM ECG – all of which run on the SentrySuite Software platform. Learn more at vyaire.com.

Telemetry Adapter Now Available in the US

Vyaire Medical has announced the US availability of its smaller, reusable ApexPro FH telemetry adapter for use with the GE ApexPro FH System. Designed with input from clinicians, the new version of the adapter connects to the GE ApexPro FH telemetry system. The smaller design offers a more secure connection making it easier for patients to move about the hospital while receiving ECG monitoring. The adapter can be used in conjunction with Vyaire's Multi-Link X2 ECG portfolio. "The new ApexPro FH adapter demonstrates our commitment to putting customers and patients first. The smaller size improves patient comfort and mobility. The compatibility with our disposable leadwires reduces cross-contamination exposure, because the leadwires can stay with the patient throughout the hospital. Both lead to improved patient outcomes, which is a win for everyone." Joel Brandon, VP Marketing, Vyaire Medical. The ApexPro FH uses one of our Multi-Link X2 solutions that allows for standardization of single patient use leadwires across multiple monitoring platforms including: GE, Philips, Mindray, Nihon Kohden and Spacelabs. Additionally, the new adapter helps optimize patient flow through the hospital allowing patients increased mobility. Infection prevention is a key metric in healthcare systems. By using our single patient use leadwires it can help eliminate the risk of cross contamination often seen with reusable leadwires.

Device Offers Rapid Change in Therapies for Clinicians

Vyaire Medical, Inc.’s bellavista 1000e ventilator has been granted 510(k) clearance from the US Food and Drug Administration (FDA). It is the newest addition to Vyaire’s high-end ventilation portfolio offering a comprehensive solution for hospitals with the integration of high flow oxygen therapy and advanced synchrony support for neonatal to adult patients in a single device. Clinicians can rapidly change therapies on a broad range of patients in an effortless way. “We began using bellavista exclusively in 2017, when it was available in Europe. It allows us to ventilate invasive, non-invasive, nasal CPAP and perform high flow oxygen therapy with one device enabling targeted, efficient patient care in any situation” said Vincenzo Cannizzaro, MD, PhD, Deputy Chief Physician of PICU/NICU, University Children’s Hospital, Zurich, Switzerland. Designed exclusively around enhancing the caregiver’s experience, the bellavista 1000e’s intuitive touch screen provides advanced graphics to easily visualize the patient’s pulmonary status, enhancing situational awareness for the caregiver. Whether its escalating care or weaning a patient efficiently, the bellavista 1000e ventilator simplifies the process by delivering optimal workflows with the goal of reducing operator error and ventilator lengths of stays. “Clinicians, respiratory therapists and bedside caregivers provided critical input in the design of this ventilator and helped us ensure we addressed their challenges in all patient care circumstances,” said Lisa Rose, Chief Marketing and Innovation Officer, Vyaire Medical. “The bellavista 1000e is a solution that provides the ultimate versatility in therapy and it can be adjusted quickly depending on patient need in time sensitive situations. These differentiators are critical in a healthcare environment which expects innovative products to improve patient outcomes. Vyaire is dedicated to developing the kinds of systems and products that meet the needs of healthcare providers.” Today, there are more than 8,200 bellavista 1000e ventilators in use across 92 countries outside of the United States. The bellavista 1000e ventilator was introduced to the US healthcare market at the American Association of Respiratory Care Congress (AARC), November 9-12, 2019 in New Orleans.

Nihon Kohden Launches New Ventilator System

Nihon Kohden, a US market leader in precision medical products and services, announced the launch of its new NKV-550 series ventilator system that offers a full suite of applications necessary in a critical care setting for patients of all ages – from neonate through adult. The NKV-550, introduced for the first time at the annual American Association for Respiratory Care Congress 2019 in New Orleans, is an innovative ventilator that features an integrated touchscreen, intuitive user interface, and onscreen help functions. The NKV-550 was developed to seamlessly transition between invasive ventilation, noninvasive ventilation and high-flow oxygen therapy, allowing clinicians to respond to a patient’s respiratory support needs without having to change devices. “Every product we bring to market is designed to simplify workflow for clinicians and benefit patients,” said Yasuhiro Yoshitake, president and CEO of Nihon Kohden America. “We saw a tremendous need in the respiratory market for a comprehensive ventilator that could respond to any patient situation while also providing excellent usability using modern technology.” The NKV-550 is a unique ventilator to offer Protective Control, a feature that uses a second graphic user interface placed outside the isolation room of a contagious patient who is under mechanical ventilation. The respiratory therapists and clinicians can view the ventilator monitors and alarms, adjust ventilation settings and alarm settings, and audio pause the alarm sound, through the second graphic user interface outside the isolation room, as long as the patient is within the sight of the clinician through the room’s glass window. When managing a patient who has a communicable disease case and is in isolation, this feature protects both the clinician and the patient because respiratory therapists and clinicians will not lose valuable minutes donning protective gowns, gloves and masks before responding to the needs of an infectious patient. This minimizes a potential hazard many healthcare workers face. An estimated 42 healthcare workers per million employed die each year from infections acquired at work. The NKV-550 was created based on the lung protective approach to ventilation and features the Gentle Lung suite of applications to provide clinically relevant, easy-to-use tools for the open-lung approach to ventilation. The ventilator offers highly customizable screen configurations enabling the ventilator to fit into your paradigm rather than require you adapting to it. The app-based design provides guided processes to help create a more streamlined, systematic way for clinicians to optimize care of their ventilated patients. The NKV-550 also offers on-screen help tools to walk clinicians through critical ventilator troubleshooting. Founded in Japan in 1951, Nihon Kohden is a leading manufacturer, developer and distributor of medical electronic equipment, with subsidiaries in the US, Europe and Asia. The company’s products are now used in more than 120 countries, and it is the largest supplier of electroencephalography products worldwide.

Monaghan Receives Prestigious Award

Monaghan Medical Corporation (MMC) has received the prestigious American Association of Respiratory Care (AARC) Zenith Award for the fifth consecutive year. The award was presented at the 65th International Respiratory Care Convention and Exhibition in New Orleans, Louisiana. The Zenith Award is a “people’s choice” award of excellence voted on annually by members of the respiratory care profession. Recipients are selected based on such criteria as outstanding service, quality, accessibility, truth in advertising and support of the respiratory care community. “Winning the coveted Zenith Award from the AARC is a tremendous honor for which our entire organization is grateful,” said Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development at Monaghan Medical. “Receiving this recognition from our industry peers for a fifth straight year validates our team’s commitment to providing our customers with the very best in respiratory care products and support.” AARC is the leading national and international professional association for respiratory care. With more than 47,000 members worldwide, AARC encourages and promotes professional excellence, advances the science and practice of respiratory care, and serves as an advocate for patients, their families, the public and the profession. Monaghan Medical Corporation, headquartered in Plattsburgh, New York (USA), is a leader in the research, development, manufacture and marketing of respiratory devices including the AEROCHAMBER Brand of Valved Holding Chambers, AEROECLIPSE II Breath Actuated Nebulizer, AEROBIKA OPEP device, and the newly released VersaPAP device. MMC’s products are developed, tested and validated at the Global Aerosol and Research Center of affiliate Trudell Medical International and are supported by more than 500 peer-reviewed and published articles. To learn more about Monaghan Medical products, visit www.monaghanmed.com.

Ventilator Gets Clearance

Vyaire Medical, Inc.’s bellavista 1000e ventilator has been granted 510(k) clearance from the US Food and Drug Administration (FDA). It is the newest addition to Vyaire’s high-end ventilation portfolio offering a comprehensive solution for hospitals with the integration of high flow oxygen therapy and advanced synchrony support for neonatal to adult patients in a single device. Clinicians can rapidly change therapies on a broad range of patients in an effortless way. “We began using bellavista exclusively in 2017, when it was available in Europe. It allows us to ventilate invasive, non-invasive, nasal CPAP and perform high flow oxygen therapy with one device enabling targeted, efficient patient care in any situation” said Vincenzo Cannizzaro, MD, PhD, Deputy Chief Physician of PICU/NICU, University Children’s Hospital, Zurich, Switzerland. Designed exclusively around enhancing the caregiver’s experience, the bellavista 1000es intuitive touch screen provides advanced graphics to easily visualize the patient’s pulmonary status, enhancing situational awareness for the caregiver. Whether its escalating care or weaning a patient efficiently, the bellavista 1000e ventilator simplifies the process by delivering optimal workflows with the goal of reducing operator error and ventilator lengths of stays. “Clinicians, respiratory therapists and bedside caregivers provided critical input in the design of this ventilator and helped us ensure we addressed their challenges in all patient care circumstances,” said Lisa Rose, Chief Marketing and Innovation Officer, Vyaire Medical. “The bellavista 1000e is a solution that provides the ultimate versatility in therapy and it can be adjusted quickly depending on patient need in time sensitive situations. These differentiators are critical in a healthcare environment which expects innovative products to improve patient outcomes. Vyaire is dedicated to developing the kinds of systems and products that meet the needs of healthcare providers.” Today, there are more than 8,200 bellavista 1000e ventilators in use across 92 countries outside of the United States.

Hamilton Medical Receives Approval

Hamilton Medical received 510(k) approval for the optional high flow oxygen therapy on the HAMILTON-G5, HAMILTON-C1 and HAMILTON-T1 ventilators, as well as for the speaking valve compatibility option on the HAMILTON-C1 and HAMILTON-T1. The option of integrated high flow oxygen therapy on the HAMILTON-G5/C1/T1 ventilators is now available for all patient populations. With this enhancement, these ventilators offer you a wide range of ventilation and therapy options, including invasive and noninvasive ventilation, and high flow oxygen therapy, all in one single device. In just a few steps, you can change the interface and use the same device and breathing circuit to accommodate your patient’s needs. To minimize the risks of hyperoxia and associated complications caused by the inaccurate administration of oxygen, Hamilton Medical ventilators offer a continuous display of all relevant monitoring parameters for high flow oxygen therapy, such as oxygen concentration, flow rates, SpO2 (optional), and trends. On the HAMILTON-G5, high flow oxygen therapy can be combined with an integrated Aerogen nebulizer (optional) to help improve therapy efficiency through nebulized drug administration. For adult and pediatric patients in pressure-controlled modes (PCV+, SPONT, PSIMV+), the SpeakValve option enables the use of conventional speaking valves with the HAMILTON-C1 and HAMILTON-T1. The use of a speaking valve in mechanically ventilated patients facilitates independent vocalization in mechanically ventilated patients, allowing them to become active participants in their healthcare. Improving communication between the patient and the healthcare team can help to reduce the patients’ anxiety and improve their sense of well-being, dignity, and motivation to wean.

Capsule Acquires Company

Capsule Technologies, Inc., a leader in medical device integration and non-critical care patient monitoring solutions, announced it has acquired Bernoulli Health. The acquisition includes Bernoulli One, a real-time clinical surveillance solution that gives care teams contextual information on a patient’s condition that can facilitate early intervention, improve patient safety and enable better clinical outcomes. The acquisition grows Capsule Technologies’ leadership position by extending the reach of its clinical platform into additional use cases by adding patient data visualization to the platform’s existing data management and connectivity capabilities. Today, hospital clinical leadership is focusing on more direct ways to improve patient safety by increasing continuous surveillance on patients throughout their entire course of stay in the hospital. Bernoulli Health’s clinical surveillance solution provides early detection of critical events so care teams can intervene before deterioration occurs. The addition of this capability furthers Capsule Technologies’ focus on improving patient safety by providing clinicians with tools that simplify clinical workflow and provide data-driven insights at the point of care. “Capsule Technologies’ success is built on our vendor-neutral approach, giving hospitals the flexibility and freedom to deploy almost any medical device,” said Kevin Phillips, Capsule Technologies’ vice president of product management. “Our customers are assured that we can connect to their devices, process data on the fly, and integrate normalized relevant physiologic and treatment data to any downstream clinical system that best meets their needs. Integrating Bernoulli Health’s clinical surveillance solution into our medical device Integration platform provides yet another option for those customers who want a tightly connected turnkey experience.” “Bernoulli Health and Capsule Technologies have a shared vision to unlock the power of medical device data to provide better clinical insights across all levels of patient acuity,” said Janet Dillione, chief executive officer of Bernoulli Health. “With the emergence in the market of clinical surveillance, predictive analytics and real-time healthcare, we are confident that bringing together these two organizations will be highly beneficial to all our stakeholders and especially customers.”

Medical Company Hosts Free Seminar

Are you going to be in the Seattle, WA area on July 30th, 2019? Hayek Medical invites you to register for a one-day free seminar that offers 6 AARC approved CRCE Units focused on Biphasic Cuirass Ventilation. Breakfast and lunch included! When: July 30th, 2019, 9:00am to 3:00pm. Where: Hilton Seattle, 1301 6th Ave, Seattle, WA 98101, USA (Windward Room). https://mailchi.mp/hayekmedical/ceuseattle

Device Unveiled to Reduce Inhaler Errors

Monaghan Medical Corporation introduced new product enhancements to continue their mission to ensure device quality for patients. Close to 50 million Americans suffer from asthma or chronic obstructive pulmonary disease (COPD) — lung conditions that seriously interfere with airflow and make it difficult to breathe. These individuals need critical daily medical treatments administered by means of an inhaler, a device that delivers medication into the body through the lungs. Related medical expenses compounded by absences from work and school total billions of dollars each year, costs which may have been prevented with proper treatment. Today, there are more than 250 inhaler brands on the market providing targeted delivery of medication to the lungs with reduced side effects when compared to oral medications. Users typically own more than one inhaler, and with so many brands available, problems can result if these inhalers are designed to operate in different ways. It should come as no surprise that less than 10 per cent of people use their inhalers correctly. To help reduce errors associated with inhaler use, guidelines recommend the addition of a valved holding chamber — a device that attaches to an inhaler and captures medication as it sprays out. Valved holding chambers streamline delivery of medication and maximize how much medication is delivered into the lungs. The most commonly prescribed metered-dose and soft-mist inhalers recommend the use of an AeroChamber Plus Flow-Vu chamber in their product information to ensure that the optimal dose of medication is received. Since its introduction in 1983, the AeroChamber brand of chambers has been continually updated, the most recent improvement being the introduction of an Intermediate Mask to its family of small-, medium- and large-sized masks. An inhaler mask is a cone-like device that fits over the nose and mouth and helps enhance the amount of medication that reaches the lungs. ComfortSeal masks are anatomically designed for different face sizes and shapes, reducing unwanted gaps and minimizing the distance between the mask and the user. Masks help users overcome challenges they may experience while determining when to inhale after activating the inhaler, resulting in optimized medical benefits and improved outcomes. With the introduction of the new intermediate mask size, the AeroChamber Plus Flow-Vu chamber product line becomes the only chamber currently FDA 510(k) cleared for use with both metered-dose inhalers and the new soft-mist inhaler formats.

New Catheter Securement Product Unveiled

Dale Medical Products, Inc. (Dale), the company known for its high quality, patient-friendly medical device securement solutions, is expanding its offering with its new Hold-n-Place® Catheter Securement Products. Like the Dale® Hold-n-Place® General Purpose Securement Devices, the new catheter securement products are Engineered Stabilization Devices (ESD) and feature a soft, comfortable, flexible design with no hard plastic parts. No skin prep is required for application, and no alcohol is required for removal. Hold-n-Place Catheter Securement Devices are available in two sizes: one for IV, arterial and mid-line catheter securement and another for CVC, PICC and arterial sheath securement. Either device is available by itself, with a transparent dressing, or with a PrevahexCHX™ Antimicrobial Transparent Film Dressing by entrotech life sciences, inc. Hold-n-Place is the first and only catheter ESD available with the PrevahexCHX dressing. Together, the two products combine the effectiveness of an ESD with the first and only CHX chlorhexidine dressing cleared by the FDA with complete antimicrobial protection throughout the transparent areas, and with the adhesive strength and transparency clinicians are looking for in a seven-day securement solution. "Clinicians tell us they appreciate the safety and security of Dale Hold-n-Place products," says John Brezack, President of Dale. "We are pleased to expand the offering with our new catheter securement devices." For more information about Dale's new Hold-n-Place Catheter Securement line, or to request a product sample, please visit https://www.dalemed.com/product/hold-n-place-catheter-securement/ or call 800-343-3980

Flow-Safe II+ Disposable BiLevel CPAP Device Now Available

Flow-Safe II+ is the only available Disposable BiLevel CPAP system. Now clinicians can easily choose either BiLevel or CPAP treatments with the twist of a dial. Includes a manometer for verifying pressures. Easy set-up. Ideal for transport and where backup Bilevel equipment is unavailable. For more information and a video, visit: https://mercurymed.com/product/flow-safe-ii-disposable-bilevel-cpap/?utm_source=ems1.com&utm_medium=banner

Device Earns Hot Products Award

Mercury Medical and JEMS (Journal of Emergency Medical Services) are proud to announce the selection of Flow-Safe II+ Disposable BiLevel CPAP device and the WoundClot Next Generation Hemostatic Agent as winners of the Hot Products Award from the JEMS EMS Today Conference and Exposition, which was held February 20-22 in National Harbor, MD. Mercury Medical was the only company to win multiple awards. Flow-Safe II+ and WoundClot were selected after a panel of judges consisting of emergency medical services (EMS) product specialists, physicians, educators, managers and paramedics reviewed a host of product contenders designed to not only improve the ability to deliver optimal emergency medical care to sick and injured patients, but also allow EMS agencies to do it safely, more efficiently and with enhanced comfort for the patient. Products were evaluated based on four distinct categories: 1) Originality; 2) Functionality; 3) Ease of use; and 4) Need in the EMS setting. Flow-Safe II+ and WoundClot were two of only 14 products selected as Hot Products after the EMS Today Hot Products team reviewed and rated dozens of products submitted by a number of companies. Mercury Medical CEO and President John M. Gargaro, M.D. said, “We were delighted to be a multiple winner of the 2019 Hot Product Award at the recent JEMS EMS Conference and Exposition. This speaks volumes about our employees at the Company and their continuous focus on nurturing and developing leading edge products in the markets we serve.” Flow-Safe II+ is the first disposable Bilevel CPAP system in the United States. This customized system provides clinicians every item needed for delivering BiLevel CPAP and CPAP therapy. Flow-Safe II+ is a single patient use device that includes an adjustable full-face mask and manometer that provides verifiable CPAP and BiLevel IPAP and EPAP pressures which are critical in delivering timely and continuous therapy. This third-generation system uses 50% less oxygen than the original Flow-Safe CPAP System. In addition, it eliminates the need for costly capital equipment maintenance and helps prevent the potential cross contamination from patient to patient from the typical expensive respiratory capital equipment in hospitals, surgery centers and pre-hospital environments. WoundClot, the Next Generation Hemostatic Agent is a patented advanced bleeding control hemostatic gauze that will prove to be a game-changer in immediate and life-saving use situations by providing for the temporary stoppage of severe blood loss. This, for example, will enable EMS providers and the ER at hospitals the capability to address accident victims’ wounds whether they be punctures, lacerations or abrasions. Once WoundClot comes into contact with blood, the solid gauze converts to an expanding gel and can absorb 2,500% its’ weight, quickly and effectively stopping severe blood loss. The biodegradable gauze is non-exothermic and contains proprietary molecular groups created in the manufacturing process which then work directly with the body’s own repair process to form a natural clot in the wound. Once the patient reaches definite treatment, the gelatinous membrane is easy to remove. Mercury Medical is the exclusive distributor of WoundClot Hemostatic Gauze. JEMS Editor-in-Chief and EMS Today Conference Chairman A.J. Heightman said, “There were an amazing group of Hot Product submissions for our reviewers to review and rate this year. All of the products reviewed were extremely innovative and well designed for the EMS industry, showing that our industry is keeping pace with the current science of emergency medicine and developing or upgrading their products to stay out in front of the science and technology curve.”

Optimizing Ventilation Via The Hayek Open Lung Concept

Did you know BCV can likely reduce the need of a tracheostomy in many patients, including ALS patients? Biphasic Cuirass Ventilation controls both phases of the respiratory cycle and has been proven to increase pulmonary muscle strength preventing the loss of chest mobility and the inability to inspire deeply in ALS patients. With the loss of bulbar function, ALS patients may also have issues with aspiration and resulting pneumonia. BCV’s secretion clearance (HFCWO) and cough option can help manage the build-up of secretions and prevent further infections. And, BCV can be used in place or in conjunction with other forms of ventilation. Are you going to be in the Arizona area on January 30th, 2019? Hayek Medical invites you to register for a one-day free seminar that offers 6 AARC approved CRCEs focused on Biphasic Cuirass Ventilation. Optimizing Ventilation Via The Hayek Open Lung Concept:
Remarkable Results With Biphasic Cuirass Ventilation runs from 8:00am to 3:30pm at the Banner Desert Medical Center in the Saguaro Conference Room. You can register at https://mailchi.mp/hayekmedical/ceu For more information on BCV, visit http://www.hayekmedical.com

Company Wins Fifth Zenith Award

Aerogen, the global leader in aerosol drug delivery, has been recognized with the prestigious 2018 Zenith Award for respiratory care excellence by the American Association of Respiratory Care (AARC). The win represents the fifth time that Aerogen has received the award. Widely recognized as the top award of the respiratory care profession, the Zenith Award is voted on by over 47,000 AARC members based on their experience and expertise with a wide range of respiratory products. Judging criteria included outstanding service, product quality, accessibility and helpfulness of sales staff, responsiveness, truth in advertising and support of the respiratory care profession. “We are honored to be recognized by the respiratory therapy community in this way. As a fifth time recipient, we are proud to retain the confidence and trust of respiratory care professionals. Aerogen is committed to work daily to maintain this valued relationship.” John Power, CEO of Aerogen. Aerogen officially received the Award at the opening ceremony for the 64th International Respiratory Congress this December in Las Vegas, NV. It will be received by two of Aerogen’s long standing employees Susan Sickal, Sales Operations and Customer Support Manager and Peter Kahane, Senior Critical Care Specialist, both of whom exemplify the traits of customer centric approach and help to make Aerogen a leader in the industry.

FeNO Monitoring Gets Recommended

Circassia Pharmaceuticals, Inc., a specialty pharmaceutical company focused on respiratory disease, announced that Fractional Exhaled Nitric Oxide (FeNO) monitoring is recommended in the latest Global Initiative for Asthma (GINA) guide, “Difficult-to-Treat & Severe Asthma in Adolescent and Adult Patients – Diagnosis and Management”. Asthma is a chronic inflammatory respiratory disease. During airway inflammation associated with allergic/eosinophilic asthma, higher-than-normal levels of nitric oxide (NO) are released from epithelial cells of the bronchial wall. Measuring the concentration of NO in exhaled breath, or fractional exhaled nitric oxide, can help identify airway inflammation. Circassia’s innovative NIOX® technology provides objective and accurate FeNO measurement of airway inflammation, and is the only FeNO testing device in the US available at point-of-care. The new GINA guide recommends FeNO measurement as an assessment tool to determine whether patients who are on high-dose inhaled corticosteroids (ICS) or low-dose oral corticosteroids (OCS) have residual inflammation. This can provide a potential predictor of good response to anti-immunoglobulin E (anti-IgE) therapy for patients with severe, allergic asthma, and is a tool to identify refractory type 2 inflammation in patients on high-dose ICS therapy. The guide suggests repeating FeNO measurement up to three times when asthma worsens before deciding if it is non-type 2. For patients with elevated type 2 biomarkers on high-dose ICS, FeNO monitoring is recommended to assess adherence before prescribing a biologic. Lastly, FeNO measurement is suggested as a means of monitoring tapering of oral corticosteroid treatment. Circassia announced earlier in 2018 that major insurer Aetna updated its policy to deem FeNO by NIOX as “medically necessary” as a part of comprehensive asthma diagnosis and management. NIOX testing is considered affordable and accessible for both patients and their physicians, as an estimated 80 percent of American lives have insurance coverage for NIOX testing. Asthma often begins in childhood, but can affect people of any age. The disease is characterized by attacks (exacerbations) of breathlessness and wheezing of varying severity and frequency, which if left untreated, can be life-threatening. Asthma is a common condition, with the World Health Organization estimating 235 million people have the condition worldwide. Asthma affects approximately 25 million people in the United States. GINA estimates that 17 percent of asthma patients are considered “difficult-to-treat”, such that their asthma is uncontrolled despite treatment with a medium or high dose inhaled corticosteroid, with a second controller and maintenance oral corticosteroid therapy, or requires such treatment to maintain good symptom control and reduce the risk of exacerbations. An estimated 3.7 percent of asthma patients are considered “severe” in that asthma is uncontrolled despite adherence with maximal optimized therapy and treatment of contributory factors, or that worsens when high dose treatment is decreased. According to GINA, type 2 inflammation is found in approximately half of people who have severe asthma. GINA was launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute (NIH) and the World Health Organization. Embracing the issue of severe asthma was a critical goal for the GINA Board of Directors and Science Committee, as their mission remains focused on maximizing benefit for patients with asthma while minimizing healthcare provider burden.


ResMed to Acquire Propeller Health

ResMed, a leader in cloud-connected medical devices and out-of-hospital software-as-a-service (SaaS) business solutions, today announced it has entered a definitive agreement to acquire Propeller Health, a digital therapeutics company providing connected health solutions for people living with chronic obstructive pulmonary disease (COPD) and asthma. Named a “2017 Most Innovative Company” by Fast Company, Propeller helps people and their doctors better manage their COPD and asthma. Propeller’s digital medicine platform consists of small sensors that easily attach to consumers’ inhalers and pair with a mobile app to automatically track medication use and provide personal feedback and insights. Propeller’s clinically validated solutions have demonstrated a 58 percent improvement in medication adherence, 48 percent increase in symptom-free days and 53 percent reduction in emergency room visits.Propeller’s ability to support people in stage II and III severity levels of their COPD are complementary to ResMed’s own suite of cloud-connected ventilators for those with stage III and IV COPD, including Astral, Stellar and AirCurve 10 ST-A with iVAPS – plus ResMed’s new portable oxygen concentrator Mobi. “Acquiring Propeller is a significant step for ResMed toward becoming the global leader in digital health for COPD," said ResMed CEO Mick Farrell. “By working with Propeller’s existing partners to offer digital solutions for respiratory care pharmaceuticals and building on our proven ability to support digital solutions at scale, we can positively impact the lives of even more of the 380 million people worldwide who are living with this debilitating chronic disease.” “Helping inhaler users improve adherence and avoid hospitalizations perfectly serves ResMed’s mission: to improve people’s quality of life, reduce the impact of chronic disease and save healthcare costs across the out-of-hospital care spectrum,” said ResMed Respiratory Care President Richie McHale.“ResMed shares our belief that connected health solutions create vastly better experiences and outcomes for people with chronic respiratory disease,” said David Van Sickle, co-founder and CEO of Propeller. “Joining forces enables us to accelerate the adoption of Propeller’s solutions at a global scale, and serve as a powerful platform for a broad set of pharmaceutical and healthcare partners.” Propeller is privately funded, and based in Madison, Wisconsin, with an office in San Francisco. It will continue to operate as a standalone business within ResMed’s Respiratory Care portfolio. There will be no immediate changes to management, locations or business processes. Van Sickle will continue in his current role, now reporting to McHale.

Hayek Medical Expands its Brand

Medical device company Hayek Medial is expanding its brand by starting up an Instagram account. The company, which bills itself as the ‘world’s home of Biphasic Cuirass Ventilation’ can be found at the @hayekmedical Instagram account. The account features helpful information and photos and diagrams of its devices. You can also tag them with #HayekBCV on the social network.

FDA Approval for Device

Lonhala Magnair is the first nebulized long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the US and the first use of the Magnair, which is based on the closed eFlow technology system, developed by PARI Pharma GmbH, to treat COPD. This technology is a virtually silent, portable, closed system nebulizer that is designed to deliver the drug in two to three minutes and allows people to breathe normally while using the device. “We are proud that the FDA has approved Lonhala Magnair as the first nebulized, long-acting muscarinic antagonist treatment option for people in the US living with COPD,” said David Frawley, Executive Vice President and Chief Commercial Officer at Sunovion. “The approval of Lonhala Magnair underscores our leadership in nebulization and the value we place on providing innovative treatment options for people living with COPD. Lonhala Magnair is an important addition to our portfolio of approved COPD therapies for people at various stages of COPD, providing the flexibility to choose handheld or nebulized products based on individual needs.” Despite the availability of several therapies, many people still struggle to control their COPD – a challenge that may be affected by the delivery method used to administer a medication, said Gary Ferguson, MD, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan. “Lonhala Magnair offers an important new option that combines the efficacy of a proven medication for COPD with the attributes of a unique handheld nebulizer that allows a person to breathe normally while taking their medication. Approximately 15.7 million adults in the US report they have been diagnosed with COPD, a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases. The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute. The disease makes it hard for people to breathe and subsequently may limit their ability to perform some routine activities, including the proper inhalation of medication. This improper medication technique may impact treatment over time and may also result in an inadequate amount of the drug reaching the lungs, potentially worsening a person’s COPD. For people with moderate-to-very-severe COPD, nebulized treatments offer an alternative to inhalers, allowing a person to breathe normally while taking their medicine. The approval is based on data from the clinical trials in the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) program, which included GOLDEN-3 and GOLDEN-4, two Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials comparing LONHALA MAGNAIR with placebo in adults with moderate-to-very-severe COPD. At study endpoints, individuals treated with Lonhala Magnair demonstrated statistically significant and clinically important changes from baseline in trough forced expiratory volume in one second at Week 12 versus placebo. An additional study, GOLDEN-5, was a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial designed to evaluate the long-term safety and tolerability of Lonhala Magnair in adults with moderate-to-very-severe COPD and included the active comparator Spiriva (tiotropium bromide) delivered by the HandiHaler device. Lonhala Magnair was generally well-tolerated in clinical studies, with the most common side effects being exacerbations and cough. The overall treatment emergent adverse events (TEAE) incidences were similar for glycopyrrolate and tiotropium groups over 48 weeks.

Company Shows Off High IQ

nSpire Health, a leading provider of pulmonary diagnostic systems, has announced the introduction of Iris IQ, a respiratory department analytics platform. The new framework of integrated technologies eliminates incongruences between pulmonary function test results, other respiratory diagnostic exams and/or symptomology adversely affecting clinical decisions in as many as 50% of the millions of cases where pulmonary functions testing is indicated each year. Iris IQ unlocks the underlying power of Pulmonary Function Testing while helping to eliminate an estimated three billion dollars in direct and indirect healthcare costs associated with poor quality testing or lack of testing and resulting misdiagnosis and treatment of respiratory diseases. Scalable in costs for single device users to complete healthcare enterprises with several devices, the new department management platform leverages nSpire Health’s patent pending PFT calibration reference standards and Iris’ unique network architecture to ensure providers consistently deliver valid results for all PFT systems’ clinical indications using any manufacturer’s PFT device. The modular solution provides interpreting and treating physicians, respiratory therapists, and department administrators new levels of trusted insights into the complete pulmonary function testing process from pre-test staging through interpretation and result delivery including verification of instrument accuracy, precision and testing practices. “We believe the lack of practical quality management tools has been concealing the true physiologic detection capabilities of pulmonary function testing,” said Michael Sims, President and CEO of nSpire Health. “Offering a comprehensive quality management solution compatible with any vendor’s PFT devices raises the quality of care for all patients in all pulmonary labs.” For the first time in the history of pulmonary function testing and in less than a few minutes per day end users can irrefutably validate a PFT devices output performance to a manufacturers stated specification limits (or to peer reviewed standardization criteria) for each lung function measurement output as required by the FDA and ISO and more importantly required for efficient clinical decision-making by treating physicians. Outdated simulators and biologic testing controls cost too much to use, take too long to perform, and have enormous limitations in detecting a PFT devices true accuracy and precision limits. Beyond clinical results, Iris IQ dashboards and custom reporting capabilities provide users intuitions into clinical operations, asset management and device utilization while supporting risk management and regulatory compliance. Based on real time quality assessments for every patient exam, an integrated learning management module securely provides specific corrective action training for technicians, department managers, and physicians using any browser or Iris Decision Workstation. “Iris IQ provided us with a deeper understanding of our lung function testing quality and cost drivers while offering our team focused training on corrective action procedures for more effective and efficient patient care. We saw instant results across facilities.” said Rodney Folz, M.D., PhD, Chief of Pulmonary, Critical Care, and Sleep Medicine at University Hospitals Cleveland Medical Center. According to Tad Scheiblich, Director of Product marketing, “nSpire Health is currently performing PFT Quality Webinars and free Department Quality Assessments.”

Positive Results for Device

CSA Medical Inc. presented positive results of its feasibility study of the RejuvenAir Metered Cryospray system at the 2018 European Respiratory Society (ERS) Congress in Paris. In an analysis of 30 patients at 6-month follow up, treatment with RejuvenAir resulted in clinically meaningful improvement in Quality of Life, as measured by Saint George’s Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT). The procedure demonstrated a strong safety profile and was well tolerated. Dirk-Jan Slebos, MD, PhD of the Department of Pulmonary Diseases, at the University Medical Center Groningen, The Netherlands reported that “The RejuvenAir therapy appears to have a beneficial response with a decrease in cough and mucus production even in our patients who had optimized medical management. The overall improvement in breathing resulted in increased physical activity supporting the potential for RejuvenAir to measurably improve quality of life in chronic bronchitis patients.” As reported at ERS, RejuvenAir therapy demonstrated strong safety and tolerability profile during the study with minimal procedure related adverse events and serious adverse events. Importantly, there were no pneumothorax or pneumomediastinum events. Patients were able to be discharged from outpatient bronchoscopy suite on day of treatment. On SGRQ, patients treated with RejuvenAir improved by an average of 10.9 points (p<0.02) at 6-month follow-up. According to peer-reviewed literature, an improvement of 4 points on SGRQ is considered to be clinically meaningful. On CAT, patients treated with RejuvenAir improved by an average of 3.4 points (p<0.02) at 6-month follow-up. According to peer-reviewed literature, an improvement of 2 points on CAT is considered to be clinically meaningful. “We are encouraged by these positive safety and feasibility results and we’re moving forward with plans to initiate a worldwide pivotal study of RejuvenAir in chronic bronchitis in 2019,” said Wendelin Maners, CSA Medical’s Chief Commercial Officer, who further stated, “We look forward to advancing this novel therapy toward commercialization to provide relief to the millions of patients suffering from COPD with chronic bronchitis.” The Safety and Feasibility Study of RejuvenAir for Treating Chronic Bronchitis Patients (NCT02483637) is a prospective, open label, single arm study of COPD patients with known chronic bronchitis is being conducted at three sites in The Netherlands, United Kingdom, and Canada. The study strongly supports the feasibility of using Liquid Nitrogen Metered Cryospray (MCS) throughout the central airways to ablate inflamed bronchial epithelium allowing non-inflamed tissue to regenerate after treatment. Phase A of the study enrolled 11 patients and treated a single lobe to assess safety, feasibility and histologic/immunologic response. In Phase B of the study, Phase A patients had their remaining lobes treated and 24 additional patients were enrolled and treated. All patients have received complete treatment of both lungs and they are being periodically followed for safety and physiologic response of their underlying chronic bronchitis to this novel treatment. Primary endpoints include, 1) adverse and serious adverse events and ability to complete all three treatments, and 2) mean change from baseline total SGRQ score. Secondary endpoints include CAT, 6-minute walk test, spirometry testing, and other objective pulmonary function tests and patient reported outcome instruments. Exacerbation rate was measured as an exploratory endpoint. Chronic Bronchitis is the largest disease subset of Chronic Obstructive Pulmonary Disease (COPD). Bronchitis is inflammation of the bronchial airways. A chronic bronchitis diagnosis is defined by cough with productive sputum of three months duration for two consecutive years. In addition to a chronic inflammation, cough and increased production of mucus, chronic bronchitis may or may not present with obstruction/partially blocked airways due to swelling and excess mucus in the bronchi, or shortness of breath (dyspnea). In the United States, there are an estimated 12.7-14.7 million people with COPD, and in 2011 approximately 10 million people sought medical attention for chronic bronchitis, a subset of COPD. Approximately 700,000 people are hospitalized for symptoms/exacerbations of chronic bronchitis every year. In Europe, there are approximately 23 million people with COPD. There are approximately 1.5 million hospitalizations per year for COPD. The RejuvenAir Metered Cryospray System is designed to spray liquid nitrogen at –196°C in a circumferential pattern within the airway. It is anticipated that the rapid freezing of the epithelial layer of the airway walls will destroy the mucus-producing goblet cells while preserving the extracellular matrix, thereby enabling the regrowth of healthy cells. The RejuvenAir System is currently under clinical investigation and is not commercially available.

Devices Design to Hold in Place

Dale Medical Products, Inc., the company known for its high-quality, patient-friendly medical device securement solutions, is again advancing the field with its new Hold-n-Place General Purpose Securement Products. With three sizes, 950 Small, 951 Medium and 952 Large, the devices are sized to fit a wide variety of applications. They secure lines and tubes in place on the patient’s body using the familiar "hook and loop" technique with a high-quality adhesive to enhance patient comfort. Hold-n-Place General Purpose Securement devices are made with skin-friendly materials, are breathable and are made without natural rubber latex to reduce the risk of allergic reactions and skin irritation. "Keeping lines and tubes safe and secure is vital to both clinicians and patients," says John Brezack, President of Dale. "Hold-n-Place Securement devices do so reliably while keeping patient comfort a top priority." These general purpose devices feature a soft, comfortable, flexible design with no hard plastic parts. No skin prep is required for application, and no alcohol is required for removal. By securing the lines and tubes from the top, bottom and sides, the devices provide superior securement for both vertical and horizontal accidental line pulls. For more information about Dale’s new Hold-n-Place Catheter Securement line, or to request a product sample, please call 800-343-3980.

FeNO Testing Deemed 'Medically Necessary' for Asthma Patients

Circassia Pharmaceuticals, Inc., a specialty pharmaceutical company focused on respiratory disease, announced that Aetna, one of the largest health insurance companies in the United States, has updated its Exhaled Breath Tests Clinical Policy to include the measurement of exhaled nitric oxide as “medically necessary” for the evaluation of asthma and for monitoring the response to long-term control therapy. Circassia’s innovative NIOX technology provides objective and accurate fractional exhaled nitric oxide (FeNO) measurement of airway inflammation at the clinical point of care. NIOX is based on the discovery that patients with allergic/eosinophilic airway inflammation, the major underlying characteristic of asthma, generally have higher than normal levels of nitric oxide in their exhaled breath.By measuring the concentration of FeNO, NIOX enables clinicians to evaluate airway inflammation in patients with underlying asthma, aiding diagnosis and helping guide treatment and reduce exacerbations. NIOX is the only FeNO device for clinical use at the point of care available in the US. David Acheson, Senior Vice President, US Commercial, said: “Aetna’s updated policy is excellent news for people with asthma and parents of children who live with asthma. The update includes data from a recent US Agency for Healthcare Research and Quality report that highlights the use of FeNO testing as a valuable part of comprehensive asthma diagnosis and management. We are pleased to see Aetna update its Clinical Policy Bulletin to include FeNO and provide expanded coverage to its members who have this serious condition.” Aetna serves more than 22 million medical members and 1.2 million healthcare professionals. The Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary, experimental and investigational, or cosmetic. Aetna reaches these conclusions based upon a review of currently available clinical information, including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas and other relevant factors.

CAIRE launches oneCAIRE

CAIRE Inc. announced the launching of a new global campaign, oneCAIRE, designed to recognize the unique individual needs of each business partner, and ensure both the company and their partners succeed. “We want a relationship, and an opportunity to build trust through our expertise in this space and through the support we provide. O2 is what we do, and oneCAIRE is our global vision to promote the CAIRE brand by spotlighting our Quality, Business Solutions, Product Portfolio, and Clinical Efficacy. These strengths bring value to the bottom line for our business partners,” said Chris Southerland, Vice President of Respiratory at Chart BioMedical. CAIRE’s consultative-selling style differentiates the CAIRE brand in the marketplace and identifies those programs that are designed to be customizable to fit large, mid-size and small customers. Programs include the Retail Partner Program, Non-Delivery Program, O2 Discharge Program, and CAIRE-sponsored training are just some of the things that CAIRE offers to their business partners. Behind each of these programs is a clinically-proven portfolio that includes liquid, stationary, and portable oxygen therapy solutions, enabling the provider to cover the entire patient lifecycle. Oxygen delivery technologies such as autoSAT, UltraSense, and now patient safety features have long made CAIRE a go-to for clinicians, providers, and the US Military who utilizes specially-designed oxygen therapy products for battlefield use. Also in the CAIRE provider toolkit is the new telehealth solution, CAIREview powered by SynsorMed. Through wireless connectivity on select CAIRE concentrators, this mobile application allows the medical equipment provider to track the location of their CAIRE concentrators, troubleshoot alerts, periodically monitor oxygen flow rates, and to help avoid costly after-hours visits. CAIREview can provide that critical link between the patient and the provider to encourage prescription compliance, and ultimately grow physician referrals. “Our full depth and breadth of products cover the entire patient lifecycle from initial diagnosis to final high-flow needs. Our portfolio is just one element in how you will experience the CAIRE brand, and our support programs make it a win-win for our preferred business partners from an affordability and operational efficiencies standpoint,” said George Coppola, CAIRE Director of Marketing.

Company Announces Upgrades to Ventilators

ResMed, a global leader in cloud-connected respiratory care devices, announced key upgrades to its Astral life-support ventilators, including Optional AutoEPAP in iVAPS for U.S. patients, a high-demand therapy option. AutoEPAP (automatic expiratory positive airway pressure) automatically adjusts a patient’s expiratory pressure in response to flow limitations or obstruction of the upper airway. AutoEPAP is now available in the United States, and already in use in other markets. It’s an option when in Astral’s iVAPS (intelligent Volume-Assured Pressure Support) mode that automatically adapts to a patient’s changing pressure needs as their respiratory disease progresses. In addition to AutoEPAP, Astral users worldwide can now: Easily change interfaces: Patients can easily change between a mouthpiece and a full face, nasal or pillows mask from a single limb circuit; customize program names: Clinicians can now name programs on a patient’s Astral device for fast, easy access. “These significant upgrades make Astral one of the most advanced life support ventilators on the market,” said Richie McHale, president of ResMed’s Respiratory Care business. “It’s already proven to stabilize ventilation in significantly fewer breaths than its leading competitor and today’s innovations offer greater ease of use and even more peace of mind to patients across a wide range of respiratory diseases than ever before.”

Portable Oxygen Concentrator Makes Official Debut

CAIRE Inc., manufacturers of oxygen therapy devices including the AirSep, SeQual and HELiOS brands, announced the official debut of the new portable oxygen concentrator, the FreeStyle Comfort, at their global manufacturing headquarters and respiratory Center of Excellence in Georgia. Following a quiet, controlled launch in January with select CAIRE partners, the company is officially putting the spotlight on the new 5-pulse-setting model featuring an innovative comfort curve and weighing only 5 pounds. “We are proud to introduce the latest in a long line of leading oxygen therapy equipment. The FreeStyle Comfort blends together durability, clinical efficacy and comfort for its user. We remain focused on providing our DME/HME providers, clinicians and their patients the products and services they need to provide the best of care,” said Earl Lawson, President of the BioMedical Group at Chart Industries, Inc. One of the major things users will notice on the FreeStyle Comfort is the shell of the device features a comfort curve that is designed to skim the natural curve of the body and make it truly a comfortable device to wear in comparison to other portable oxygen concentrators that come in oval and more square shapes that do not offer a contour. “Today’s launch is the culmination of a lot of hard work and innovation,” said George Coppola, CAIRE Director of Marketing. “Our team has taken the development of this project extremely personal from the technological aspects to ergonomics. We pushed ourselves on all of the details – Is it comfortable? Where is the center of gravity? Can it be worn with or without a bag? We ultimately want the oxygen user to live their life to the fullest and maximize their comfort as they do it.” Operational via wall outlet (AC) power, motor vehicle (DC) power, or by rechargeable battery power, the device is designed for travel including its FAA approval for use on commercial air flights. The FreeStyle Comfort offers an easy-to-use interface with glow-in-the-dark buttons and LCD display screen that shows prescribed flow setting and remaining battery charge. User-replaceable battery packs come in two sizes, 8-cell and 16-cell, and can operate up to 4 and 8 hours, respectively, at pulse setting 2, extending the user’s time away from electrical power. The FreeStyle Comfort delivers up 1050 milliliters of oxygen per minute and is equipped with CAIRE’s UltraSense technology, ensuring a pulse of oxygen is delivered quickly in the early stages of the breath, reducing skipped breaths. And, should a no-breath alarm occur, the device will deliver oxygen therapy rapidly at its current setting at a rate of 20 breaths per minute until this alarm condition has been resolved. The first smart portable oxygen concentrator, the FreeStyle Comfort comes with wireless connectivity capabilities for providers to periodically monitor location and usage through CAIRE’s telehealth solution, CAIREview™ powered by SynsorMed. This helpful mobile application can provide a critical link between the patient and the provider, dedicated to supporting their respiratory health care needs. According to the National Heart, Lung and Blood Institute, approximately 12 million adults in the US are diagnosed with COPD, and there are an additional 12 million adults in the US who are thought to have undiagnosed COPD. Oxygen therapy is often prescribed for the treatment of COPD and to encourage its user to maintain an active lifestyle.

Glucose Hospital Meter System Approved for Testing

Nova Biomedical has announced that the StatStrip Glucose Hospital Meter System has been cleared by the US Food and Drug Administration (FDA) for fingerstick capillary testing with critically ill patients (K181043). StatStrip is the only glucose meter to earn this clearance and can now be used with arterial, venous, or capillary specimens from all patients including critically ill. The use of any other meter with critically ill patients is considered off label by the FDA and high complexity testing by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA). The FDA granted 510(k) clearance to StatStrip for capillary testing with critically ill patients following extensive prospective and retrospective studies performed at the Mayo Clinic in Rochester, MN, and Johns Hopkins Bayview Medical Center in Baltimore, MD. The submission data comprised 16,778 patients ranging from one month to 106 years old, all who were receiving intensive medical intervention/therapy in critical and intensive care settings including burn, cardiac, medical, orthopedic, neurological, and surgical. StatStrip’s capillary results were equivalent to the arterial and venous plasma results measured on a central laboratory IDMS traceable reference method. The FDA clearance indicates that StatStrip is safe, effective, and reliable for use by CLIA-waived operators with critically ill patients. StatStrip’s glucose technology is the primary reason for the clinically acceptable agreement between the capillary and plasma glucose results. StatStrip is the only glucose technology for point-of-care testing (POCT) that measures and corrects for abnormal hematocrit and has no clinically significant interferences, which can lead to the mismanagement of critically ill patients. Capillary specimens are easy to collect and the least invasive glucose test at the point of care. Capillary specimens provide benefits such as rapid and actionable glucose results for immediate glycemic assessment and intervention, saving time for health care providers and improving safety and outcomes for patients. StatStrip’s new capillary clearance eliminates the need for hospitals using StatStrip to define “critically ill.” Hospitals using other glucose meters cannot test critically ill patients with those devices with any specimen type (arterial, capillary, or venous); such use is considered off label. In 2014, StatStrip became the only glucose meter to receive FDA clearance for arterial, venous, neonatal arterial, and neonatal heel stick use in all hospital and all professional healthcare settings including with critically ill patients (K132121), based upon a multicenter, four-year, prospective study conducted at five prestigious university medical centers. In that study, whole blood glucose measurements of 1,698 critically ill patients spanning 257 different medical conditions and over 8,000 medications were found to be equivalent to plasma glucose central laboratory IDMS traceable methods.

Firms Join Forces on Sleep Apnea Research

ResMed, a global leader in sleep apnea treatment and connected health solutions, and Verily, an Alphabet company, has announced their agreement to form a new joint venture. Combining ResMed’s expertise in sleep apnea and Verily’s advanced health data analytics technologies, the U.S.-based joint venture will study the health and financial impacts of undiagnosed and untreated sleep apnea, and develop software solutions that enable healthcare providers to more efficiently identify, diagnose, treat and manage individuals with sleep apnea and other breathing related sleep disorders. Sleep apnea is a sleep breathing disorder that affects an estimated 54 million Americans (calculated based on a 16-country prevalence data study),1 and is associated with heart disease, stroke, type 2 diabetes and other life-threatening conditions. Despite the condition’s high prevalence and increasing public awareness, past research has shown that approximately 80 percent of individuals with obstructive sleep apnea are undiagnosed, 2 untreated and therefore unaware of their own risk and of the benefits that therapy could provide. “The vast majority of people with sleep apnea don’t realize they have it, and therefore don’t seek accessible, effective treatment to mitigate its effects and long-term health risks,” said ResMed Chief Medical Officer Carlos M. Nunez, M.D. “The combined industry expertise, scalable infrastructure, and data analytics capabilities of ResMed and Verily can unlock meaningful ways to identify these individuals and support their journey to improved sleep, health and quality of life.” “Approaching a widespread health problem like sleep apnea through collecting, organizing and activating health data is central to Verily’s mission,” said Jessica Mega, M.D., M.P.H., Chief Medical and Scientific Officer at Verily. "By better identifying at-risk individuals as well as generating real-world evidence regarding the value and effectiveness of treatment, this collaboration has the potential to improve outcomes for millions of people living with sleep apnea, and potentially other related conditions." The joint venture, subject to customary closing conditions, including regulatory approvals, will operate as a separate venture from ResMed and Verily.


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