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Therapy Devices Unveiled

California company Vortran Medical Technology 1, Inc. is highlighting an array of devices for use by RT professionals. The GO2VENT is a unique single-patient-use resuscitator and has received CE Certification to market in European Countries, with added features like copper springs, and new FiO2 controls. It has been tested and is certified as MR Conditional per Dr Frank Shellock. Vortran is also the manufacturer of the PercussiveNEB 2.0, a single patient, multiple use, vibratory therapy device with a high-output nebulizer for patients suffering from restricted airway and secretion clearance issues. The PercussiveNEB 2.0 operates efficiently at flows of 25-30 LPM. The company also offers its Manometer, a single patient use, airway pressure indicating device for the purpose of monitoring a patient’s ventilation conditions with devices such as the GO2VENT or other similar resuscitator/ventilators. The Manometer is made with new copper beryllium springs, making it MRI Conditional and does not cause artifacts in the picture. There are two versions of this device — one with a tee connector and the other with a vertical connector.

Significant Cost Reduction in COPD Care

The Aerobika Oscillating Positive Expiratory Pressure (OPEP) device (Monaghan Medical Corporation) is a cost-effective treatment option in the management of COPD exacerbations, according to a study published October 20 in the International Journal of COPD. This study, which used data from the published literature and national fee schedules to model the cost-effectiveness of the Aerobika OPEP device, shows that it provides both clinical benefit and direct medical cost savings in a post-exacerbation care COPD population. COPD is a major (and growing) source of morbidity, mortality and healthcare utilization, with hospitalization for acute exacerbations being the biggest cost driver. Once a patient experiences an exacerbation, the risk of further exacerbation is increased two- to four-fold, and many patients experience two or three exacerbations every year. As many as one in five patients discharged from hospital following an exacerbation are re-admitted within 30 days. The economic burden on the healthcare system associated with COPD is significant; in the US alone, the cost of COPD in 2010 was estimated to be US $50 billion; $30 billion in direct healthcare expenditure, with the remainder accounted for by indirect costs such as productivity losses and costs to families. Approximately half of the direct costs could be accounted for by hospital care for COPD exacerbations, which supports the GOLD guideline treatment goals of minimizing the negative impact of exacerbations and preventing recurrences. Healthcare systems in many countries acknowledge the problem, and policies are now being put in place to try to address it; the US Medicare Hospital Readmission Reduction Program penalizes hospitals for excess 30-day, all-cause readmissions after a hospitalization for an acute exacerbation of COPD. The Aerobika OPEP device is a drug-free, handheld mechanical oscillating positive expiratory pressure (OPEP) device that has been designed to address the structural and functional challenges in the airways of patients with COPD. When the patient exhales through the device, it helps to expand the airways, loosen and expel mucus from the lungs and may also enhance drug deposition. It has been shown to improve lung function, exercise capacity and quality of life in COPD patients, and a recent real-world study showed that the device reduced exacerbation rates in patients during the critical 30-day post-exacerbation period. Using data from the latter study to provide real-world input, the authors of this current analysis showed cost savings ($553 per patient) and improved outcomes (equivalent to 6 fewer exacerbations per 100 patients per year) with the Aerobika OPEP device compared with no OPEP/PEP use, and concluded that the device provides cost-effective treatment for post-exacerbation COPD patients. The authors also used various scenarios to investigate the likelihood of the benefit continuing over a full year, and predicted further clinical and cost benefits (21 exacerbations per 100 patients per year; cost savings of $1,952 per patient). Author Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development noted, “Our model provides evidence of clinical and cost benefits of the Aerobika OPEP device in that critical 30-day period following an exacerbation. Given the high burden of COPD — in particular, costs relating to exacerbations — in the US population, we would expect that even a small benefit would have a significant impact on the healthcare system”. He went on to say that, although further studies would be needed to validate the long-term effectiveness, these data also give a good indication that the benefits will be sustained with long-term use.

Trial Approved In Canada

Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, announced that the Therapeutic Products Directorate of Health Canada has cleared an investigator sponsored, pilot clinical trial application exploring the treatment of Non-Tuberculous Mycobacteria (NTM) with Novoteris' Thiolanox inhaled nitric oxide gas, using its unique computerized trace-gas delivery system. This single center open label trial will recruit 10 subjects to the Vancouver clinical site. This trial will enable the testing of nitric oxide in patients who have this debilitating disease and who are excluded from the Novoteris Phase 2 placebo controlled trial recruiting patients with Cystic Fibrosis (CF) in North America. Novoteris has demonstrated the broad-spectrum anti-microbial property of nitric oxide effectiveness against mycobacterium both with in-vitro studies and a 4.5 log decrease in sputum bacteria levels in two human subjects with Mycobacterium abscessus that were treated in its pilot clinical trial of patients with Cystic Fibrosis in Europe. Gaseous nitric oxide's potent antimicrobial properties, lack of bacterial resistance, and small molecule penetration capabilities could provide a promising alternative, non-antibiotic approach to treating infections in people living with this disease. "The clearances by Health Canada will enable us to expand our work with this novel therapy to a wider range of people with an exceptional need for more effective antimicrobials and represents another important opportunity for Novoteris," stated Alex Stenzler, President of Novoteris.

Device Receives Innovative Technology Designation

Monaghan Medical Corporation announced its Aerobika Oscillating Positive Expiratory Pressure (OPEP) device has received a 2017 Innovative Technology designation from Vizient, Inc., the largest member-driven health care performance improvement company in the country. The designation was based on direct feedback from hospital experts who interacted with the Aerobika OPEP device at the Vizient Innovative Technology Exchange in Denver. The device is a drug-free, handheld mechanical oscillating positive expiratory pressure (OPEP) device that has been designed to address the structural and functional challenges in the airways of patients with COPD. When the patient exhales through the device, it helps to expand the airways, loosen and expel mucus from the lungs and may also enhance drug deposition. It has been shown to improve lung function, exercise capacity and quality of life in COPD patients, and a real-world study showed that the device reduced exacerbation rates in patients during the critical 30-day post-exacerbation period. These improved outcomes (equivalent to 6 fewer exacerbations per 100 patients per year) equate to a cost savings of $553 per patient with Aerobika compared with no OPEP/PEP use, making the device a cost-effective treatment for COPD patients. "We are extremely pleased to have been awarded this prestigious recognition from Vizient," said Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development. "Our device was recommended by Vizient members, which is a validation of all of the design and clinical work we have done to support our customers. We are the only OPEP device to have received this designation at this year's Innovative Technology Exchange, and are proud it was recognized to deliver improved outcomes and enhanced safety." "Based on feedback from attendees at the Vizient Innovative Technology Exchange, it was determined that the Aerobika OPEP device should be recognized with an Innovative Technology designation. This designation will be noted in our online member contract catalog. Congratulations to Monaghan Medical Corporation on receiving this status," said Debbie Archer, director of procurement and Vizient Innovative Technology Program lead. Vizient represents a diverse membership base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents more than $100 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with member-led councils and task forces to review potentially innovative products. If it is determined that a product is innovative, Vizient may award a contract outside of the competitive bid cycle.

Device For Airway Function Approved

Thorasys Thoracic Medical Systems Inc. has announced that the US Food and Drug Administration (FDA) has approved the sale and the distribution of the tremoflo C-100 Airwave Oscillometry System (AOS), a medical device that offers fast, easy assessment of large and small airway function. Measurements are obtained during tidal breathing and without patient effort, which makes it a suitable device for a wide range of patients. "Today's approval is the payoff of more than seven years of persistent hard work by the Thorasys team to develop the innovative tremoflo C-100." said Thorasys co-founder, president & co-CEO, Thomas F. Schuessler. Thorasys Thoracic Medical Systems Inc. is a respiratory medical device company based in Montreal, Quebec, Canada. Thorasys applies cutting edge research and technology to the development of products for pulmonary assessment. It designs, manufactures and commercializes pulmonary function test equipment for the assessment and monitoring of lung diseases such as Asthma and COPD. The company is currently focused on expanding. You can find out more at www.thorasys.com.

AffloVest Unveiled for Mobile Use

International Biophysics Corporation, a global medical device manufacturer and the pioneer of mechanical oscillation vest therapy, has introduced its next generation AffloVest fully mobile respiratory HFCWO (High Frequency Chest Wall Oscillation) airway clearance vest. The AffloVest is battery-operated and uses Direct Dynamic Oscillation technology, which closely mimics hand CPT (Chest Physical Therapy) to help mobilize and clear secretions from the lungs, and allows for full freedom of mobility during treatment. Doctors prescribe AffloVest for patients across a wide range of ages who have severe respiratory diseases such as bronchiectasis, cystic fibrosis, and certain neuromuscular diseases. This next generation AffloVest, which began shipping September 1, is much lighter, quieter, and more efficient, with a smaller profile battery and long-life, state-of-the-art motors, offering improved patient ease of use. The new AffloVest is on average 2 pounds lighter (more than 20% less weight) than the previous version - which was already by far the lightest mobile, mechanical oscillation vest on the market. The new AffloVest also uses streamlined components and tailored styling for a sleeker, slimmer fit. International Biophysics founder and CEO, H. David Shockley said: "With this next generation AffloVest, we have once again listened to patients and clinicians to remain the innovator and leader in mechanical oscillation vest therapy. AffloVest was already the lightest fully mobile vest on the market, and our new version is even lighter. Patient comfort and ease of use during treatment is very important, and weight is the major contributing factor to comfortable, sustainable mobile therapy. Simply put, if it's too heavy and difficult to use, patients are not going to like it. AffloVest is light and easy to use compared to other vests." In April 2017, Hill-Rom announced that it was introducing an Afflo-style vest airway clearance device also using mechanical oscillation technology. According to their product literature, that vest will weigh 5 lbs. (38%) heavier than the AffloVest, is restricted to patients 15 years of age and older (in contrast to the AffloVest, which is not age-restricted), and will be available in only one size, unlike the AffloVest, which is available in many sizes to facilitate proper fit for anatomically-targeted treatment. As Hill-Rom's product is not yet commercially available on the market, International Biophysics is not able to independently validate Hill-Rom's promotional claims. Shockley added, "We welcome competition and view imitation as validation that our fully mobile mechanical oscillation is the gold standard for mobile mechanical oscillation therapy. We have thousands of AffloVests already in use and, more importantly, we have clinician data showing lung function improvement with patients. AffloVest is the original, proven innovator in mechanical oscillation vest airway clearance therapy." International Biophysics brings to market innovative, disruptive medical devices and technologies aimed at improving treatment therapies and patient outcomes. Centered on a precision ISO 13485 certified, FDA registered quality controlled USA manufacturing facility in Austin, Texas, International Biophysics has a 25-year pedigree of successful medical product and technology launches around the globe.

New Mask Conforms to Infants' Faces

Respiralogics' announces the US release of the Babi.Plus nMask precisely designed to easily conform to an infant's face, facilitating a good seal for optimal ventilation during resuscitation and non-invasive support. The soft, brushed silicone material minimizes skin irritation. The circular design of the nMask provides a comfortable anatomical seal for the very low birth weight infants through toddlers. The clear nMask provides a good view of the patient/mask interface to ensure proper fit and size. The Babi.Plus nMask is offered in 6 sizes to accommodate the ELBW infant through small pediatric patient. Integral 15mm connector with two level barb design at the inlet of the nMask allows for easier attachment and better fixation. Available in 25mm, 30 mm, 35 mm, 40 mm, 45 mm and 50 mm masks; each nMask is individually packaged and ready for use with resuscitation bag or t-piece resuscitator system. The Babi.Plus nMask can be used in all neonatal critical care units, delivery rooms, pediatric critical care units and special procedure units. Respiralogics specializes in providing tools to meet the unique needs of respiratory patients. We listen to our customers and use that knowledge to assist in development and support of specialty products to benefit patients and clinicians. We have joined with leading specialty respiratory distributors across the USA to provide expert local assistance and the training required for successful implementation. For more information on the Babi.Plus nMask and all Respiralogics products go to www.respiralogics.com

Ventilating Mask Goes Portable

Pinnacle Sciences, a U.K.-based diverse research and development company, has released news of its latest development, the highly portable, battery-operated Ventilating Mask. A market first, the device is unique in that it provides many modes of therapies — and as opposed to conventional devices that require a tube to connect from a power unit, this device fits directly on the mask completely eliminating dead space. This allows for lower pressures to be used, which the company claims will mean significantly increased comfort for the patient. The device can also be used with a tube, be clothes mounted, or put in a pocket. The device line, expected to cost around $330 with a bundled mask, is not just a CPAP or bi-level device. Variants of the line include full ventilation, cough assistance, as well as high-frequency modes (HFO). Later models will also allow for invasive ventilation options, at similar pricing. Wolf Hayek, President and CEO of Pinnacle Sciences, commented, "We are very proud of this new patented technology, which is set to shake the CPAP/Bi-Level/Cough Assistance and Ventilator markets to the core. The proposed price point of this device, we believe, will shake out the weaker players in the respiratory and sleep markets, and send a shock wave through the industry as a whole. The phrase game changer is often thrown around. This technology will likely end the game for some, and allow others to play it in a completely different way altogether." Hayek added, "DME companies throughout the United States have had to deal with the reality of vastly decreased reimbursement for services and products they provide, often providing those services at a loss. We hope to change that. The line-up of products isn't just aimed at the sleep market, which today is oversubscribed as well as over prescribed — we see this technology as an eventual replacement of a whole host of products for use both in the hospital and the home, at a price point that does away with servicing and other costs associated with competing products. The devices themselves — we see as disposables — for the cough, ventilation and other respiratory arenas. It's cheaper, more versatile, and just so much more convenient." Pinnacle Sciences, a Hayek company, specializes in the development of innovative technologies in the health care, military and transport sectors. For further information, visit www.VentilatingMask.com.

New Adapter for Soft Mist Inhaler Medication Delivery

ODAPT Soft Mist Adapter has received FDA approval and is now available in the United States. ODAPT is the only product created specifically for use with the Soft Mist family of inhaled medications. Designed by a Respiratory Therapist to provide clinicians and patients a solution for face mask and tracheostomy application of Soft Mist Inhalers (SMI). ODAPT aids in the delivery of soft mist inhaled medications for pediatric and elderly patients where a face mask is required. As well, it expands the delivery of soft mist for tracheostomy patients of whom in the past had no delivery option. Respiralogics and McArthur Medical will introduce ODAPT to the US market during the 2017 AARC meeting, booth 212. McArthur Medical produces the ODAPT family of products. McArthur Medical is a company focused on the development of respiratory innovations. Respiralogics is a provider of innovative products for hospital, emergency, home and specialty care.

Tech Leader Joins Respiratory Therapy Advisory Board

Alex Stenzler, Founder and President of Novoteris and President of 12th Man Technolgoies in Greater Los Angeles, has joined the Editorial Advisory Board of Respiratory Therapy. Stenzler has been described as a “genius in science and engineering - an inventor and innovator through and through.” His certifications included Registered Pulmonary Technologist-NBRC, and Certified Respiratory Therapy Technician-NBRC. Through research grants, Stenzler was: Principal Investigator, Passive measurement system for respiratory mechanics in newborns, National Institute of Health 1985-1986; Principal Investigator, Passive measurement system for respiratory mechanics in ventilated newborns, National Institute of Health 1986-1987; Principal Investigator, Nitric Oxide for Prevention and Treatment of Pandemic Flu, Defense Advanced Research Projects Agency (DARPA), 2010-2011. Stenzler was honored in 2001 by the March of Dimes as Orange County Technology Leader; and in 2008, he was honored with the Cardinal Health Founder’s Award. Stenzler has also served as an executive with such companies as CareFusion 207, Cardinal Health, and SensorMedics.

Connectivity Solution Announced

Instrumentation Laboratory announced the launch of its Customized Connectivity solution, GEMweb Plus 500, to hospitals and hospital networks around the world. From a single dashboard, GEMweb Plus 500 offers complete control of GEM Premier Critical Care testing systems, including new GEM Premier 5000 with Intelligent Quality Management 2 (iQMâ2), as well as connectivity to non-IL-manufactured devices at the point-of-care. Expanding upon the original GEMweb Plus platform, GEMweb Plus 500 offers enhanced mobility with accessibility from tablet devices, in addition to any networked analyzer or PC. Seamlessly integrating control of analyzers, test results and operators into one easy-to-use system, GEMweb Plus 500 simplifies and centralizes point-of-care testing management. To ensure quality management, users can monitor iQM2 and iQM, including detection, correction and documentation of corrective actions in real-time. Facilitating accreditation, GEMweb Plus 500 automates multi-level operator authorization and full traceability of users, actions and competency certification. “GEMweb Plus 500 Custom Connectivity addresses the challenge of managing point-of-care testing in hospitals today. Combining test results, analyzer and operator data, it offers Lab Managers and Point-of-Care Coordinators real-time control from anywhere, anytime, as well as seamless accreditation support,” said Giovanni Russi, VP of Worldwide Marketing at IL. “Together with our new GEM Premier 5000 system, GEMweb Plus 500 Custom Connectivity delivers a complete Critical Care testing solution for improved patient care and efficiency.” GEMweb Plus 500 supports integration with Hospital Information Systems, Laboratory Information Systems and Electronic Medical Records. Users can access data from any networked GEM Premier analyzer, including GEM Premier 5000, 4000 and 3500 systems, and non-IL devices in real-time. Connectivity to ROTEM, Hemochron and other IL systems is currently in development.

Industry Leader Joins Advisory Board

Dan Van Hise, Vice-President of Marketing with Chart Industries’ BioMedical Division based in Ball Ground, GA, has joined the Editorial Advisory Board of Respiratory Therapy. The BioMedical division includes CAIRE Inc., a globally-recognized brand in oxygen therapy and manufacturer of portable and stationary oxygen concentrators, and liquid oxygen therapy systems. Dan has been an RRT since 1981, beginning his career as a staff therapist at Beth Israel Hospital in Boston and then quickly moving up the ladder to the position of Shift Supervisor and Clinical Educator. He then moved to several other hospitals in the New England Area in management roles, including the Emerson Hospital and the Elliott Hospital. During this time, he also became more involved in Neonatal and Pediatric Respiratory Care and early on became one of the first Neonatal-Pediatric Specialists. Following this achievement, Dan then moved to Colorado to serve as the first Neonatal Respiratory Supervisor at CU Medical Center (University of Colorado). It was during this time that he became an expert in neonatal lung function and was a key contributor in the design of a product called VenTrak that was sold to Novametrix Medical Systems. Since 1992, Dan has been highly involved in the marketing and design of Respiratory Products including mechanical ventilators, oxygen therapy devices, CPAP devices, non-invasive ventilators, and several respiratory diagnostic devices. He is also very active with the AARC International Committee and strongly supports the growth of the Respiratory Care profession and industry.

Hans Rudolph Adds Manufacturing Space

Device manufacturer Hans Rudolph is increasing its manufacturing capabilities by adding two additional CNC (Computer Numerical Control) Mills to its manufacturing floor. The additions of these two machines will help increase its manufacturing capabilities and efficiencies, which will in turn help Hans Rudolph go after new business and help increase its already expansive product line. The line includes masks for pulmonary function/exercise testing, CPAP, BiLevel, NIV, EMS resuscitation, transport ventilation, hi-flow CPAP, Critical Care Ventilation, HBOT, Custom Research applications, Flow, Pressure & Gas Measurements data acquisition and software devices, Linear & Bi-directional Pneumotachometers, Linear Resistors, Volume Calibration Syringes, Volume Validators, DLco Simulators, Flow/Volume Simulators, O2 Conserver Testers, Respiratory Two-Way Non-Rebreathing Valves, Non-Diffusing Gas Bags, Mouthpieces, Nose Clips, Valve Head Supports, Cardiac Output CO2 Rebreathing Valves, Inspiratory Occlusion Valves, Re-Calibration Services on Syringes, Pneumotachs & Resistors, and Custom devices.

New Patient Monitoring Unveiled

Medtronic plc has announced the US launch of the Vital Sync monitoring and clinical decision support (CDS) solution. The system is designed to simplify time-intensive patient care processes and help clinicians prevent or mitigate harmful and costly adverse events. The Vital Sync CDS solution combines remote monitoring software with wireless monitoring devices and a series of customizable CDS mobile applications to improve clinical protocol implementation and management of patients on medical-surgical floors and in the ICU. The Vital Sync CDS solution gathers patient physiological data directly from a variety of wireless and bedside devices, manufactured by Medtronic and third-parties. Analytics are continuously and automatically calculated, with customized alerts and notifications to help clinicians know as soon as possible if a patient is deteriorating. Respiratory therapy and nursing teams can remotely access patient data to make insightful assessments for more effective and earlier interventions. Patient data is accessed through the Vital Sync virtual patient monitoring platform. The solution also offers customizable tools, such as the Vital Sync Physiological Patch, a lightweight wireless device applied to the chest area that continuously collects and transmits physiological data, including heart rate, respiration rate, single-lead ECG and body position, to monitor vitals, facilitate pressure ulcer prevention protocols and help identify patient deterioration. The Vital Sync Weaning Readiness and SBT Monitoring App allows clinicians to continuously monitor and receive alerts indicating when a mechanically ventilated patient is ready to begin a weaning trial based on established clinical protocols. It also remotely tracks a patient’s breathing pattern and other vitals through a spontaneous breathing trial so that clinicians can intervene if a patient falls outside predefined thresholds. The Vital Sync Early Warning Score App applies automated calculations based on published evidence for an early warning score to help give clinicians an earlier indication of patient deterioration. The app can detect subtle changes in patient deterioration using multiple parameters—enabling clinical intervention before a single parameter device would recognize a problem. Many common hospital-based patient safety issues are preventable. According to a recent report by the ECRI Institute, the top three patient safety concerns for healthcare organizations in 2017 are: insufficient management of electronic health record data, unrecognized patient deterioration and ineffective use of clinical decision support tools. The Vital Sync CDS solution was designed based on clinician input and clinical evidence to help hospitals avoid these and other patient safety challenges.

Novoteris, LLC Receives FDA and Health Canada Clearance

Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, announced that both the US Food and Drug Administration and the Therapeutic Products Directorate of Health Canada have cleared its Phase 2 clinical trial application. Novoteris will now begin recruiting subjects into its Phase 2 trial that will be using inhaled nitric oxide for the treatment of Cystic Fibrosis (CF). This multi-center trial will randomize sixty subjects recruited from five cystic fibrosis research centers (Seattle, Los Angeles, Milwaukee, Charleston and Vancouver) to either Thiolanox nitric oxide product or a placebo treatment, delivered with its unique computerized trace-gas mixing system. The Novoteris investigators’ Phase 1 pilot trial in Europe reported encouraging microbiological and significant lung function changes following two weeks of the same treatment in patients with CF. The broad-spectrum anti-microbial property of nitric oxide widens the enrollment eligibility of subjects in this Phase 2 trial with the only exclusion being for Non-Tuberculosis Mycobacterium (NTM), which will be studied in separately planned trials. Gaseous nitric oxide’s potent antimicrobial properties, lack of bacterial resistance, and small molecule penetration capabilities could provide a promising alternative, non-antibiotic approach to treating infections in people living with the disease. "The clearances by the FDA and Health Canada will enable us to advance our work with this novel therapy and represents an important step for Novoteris” stated Alex Stenzler, President of Novoteris. Cystic fibrosis (CF) is an autosomal recessive genetic disorder that affects the lungs most critically. Difficulty breathing is the most serious symptom, which results from frequent lung infections that are most often treated with lifelong inhaled antibiotics. Development of drug resistance to available antibiotics is a major concern for patients with CF.

Oscillating Positive Expiratory Pressure Device Launched

D R Burton Healthcare Products LLC announced the launch of the iPEP Oscillating Positive Expiratory Pressure (OPEP) device, which uniquely combines OPEP and Incentive Spirometer therapies to address all-three respiratory needs: lung expansion, treatment of atelectasis, and secretion clearance. “The iPEP system represents a breakthrough in airway secretion clearance therapy by providing patented volumetric-based OPEP therapy. The iPEP takes the mystery out of OPEP therapy by providing patients and healthcare providers with biofeedback that measures the patient’s inspiratory capacity during therapy,” according to Dennis Cook, BSRT, RRT, CEO of D R Burton. Along with a slow-coached inhalation, the iPEP provides superior Expiratory Flow Bias, a key driver of secretion clearance outlined in a recently published study. The iPEP system includes a palm-sized PocketPEP, a compact OPEP device for active patients for use at home to help prevent pulmonary-related readmissions. Cook explains, “There is a need to prevent pneumonia in high risk patients, such as post-operative and patients with increased mucous production. The D R Burton family of OPEP products are designed to reduce the risk of not only hospital acquired pneumonia, but also reduce risk of pneumonia at home after discharge.” D R Burton will be meeting with clinicians to discuss these products both at the American Thoracic Society International Conference on May 19-24 in Washington, DC and at the National Teaching Institute & Critical Care Exposition on May 22-25 in Houston, TX.

FDA Clears First Full Home-Use Spirometer with Wireless Connection

Monitored Therapeutics, Inc. (MTI), an emerging best-in-class remote patient management company, has received FDA 510(k) clearance for its GoSpiro Home Spirometer. This is the first spirometer that was specifically developed as a home-use wireless connected spirometer that works with a wide range of smartphones, tablets or PCs. Michael Taylor, Chief Development Officer, pointed out that “The GoSpiro is the only spirometer currently on the market that has met the latest and more stringent ISO and FDA device requirements for home use.” The GoSpiro collects diagnostic quality forced spirometry (FVC) and slow spirometry (SVC) with the same accuracy as hospital laboratory systems and provides immediate feedback to patients on the quality of their test performance. The GoSpiro seamlessly integrates with MTI’s GoHome™ Patient Health Monitor, which collects and transmits data from patients and delivers physician’s instructions to them, and with a suite of remote patient monitoring tools already integrated to monitor diseases such as Asthma, COPD, heart disease, hypertension and diabetes. Monitored Therapeutics, Inc. continues to strengthen its focus on respiratory disease management with the addition of the GoSpiro. "The GoSpiro’s 510(k) marks a critical milestone towards completing our system to manage patients with pulmonary disease in their homes.” said Monitored Therapeutics, Inc. Co-founder and CEO William Zimlich. "This is one more step towards our goal of improving patients’ lives and reducing healthcare costs." MTI products include GoHome, GoSpiro, and the MTI CarePortal. Monitored Therapeutics, Inc. is based in Dublin, OH with technology development offices in Garden Grove, CA. For additional information, visit: www.monitoredrx.com.

Automatic Resuscitator a Go

Vortran Medical announced that it has been granted FDA 510K and CE certification approval for the new and improved automatic resuscitator called the GO2VENT (Gas Operated Ventilator). The latest addition to their product line offers an option for ventilation of patients during an MRI or CT scan. The GO2VENT has been tested per FDA regulations by Dr Frank Shellock to meet the MRI compatibility testing and has been approved as a MR Conditional device and is perfect for use during a scan. The new model uses Copper springs to remove the chance of artifacts in the MRI picture. The GO2VENT can be used on a wide patient population from 10kg and above and is a great option for post-operative transport, isolation areas, emergency use and of course disaster management. The new GO2VENT offers the user an ability to save on oxygen consumption now with an easily changeable FIO2 controller which allows the clinician to easily change from 100% O2down to 50% to save gas especially when using a tank during a transportation. The New and improved GO2VENT has changed colors to a more attractive blue and offers clinicians a simple 3 step set up guide right on the device to easily and rapidly set up the resuscitator on a patient especially during an emergency type situation when time is of the essence. For more details, visit the VORTRAN Medical website www.vortran.com.

Getinge Unifies its Brands

Getinge has announced that it has unified all its current brands under the single brand of Getinge to better convey its customer offering. As part of this new brand structure, the company has rolled out a new brand identity, which all its products will carry in the future. The rapid growth of what was previously known as Getinge Group over the last 25 years, primarily through acquisitions, has resulted in an extensive brand portfolio, including ArjoHuntleigh, Maquet, Lancer, Atrium and others. "In line with our ongoing transformation to make our company even more customer-centric, we have taken the next step of unifying all of our brands under the single brand of Getinge. This new brand structure will further strengthen our position as a leading global medtech company. Some of these brands, such as Maquet, will become product family names under the Getinge master brand," said Raoul Quintero, President of the Americas at Getinge. "As a single-brand company, we will also be better able to convey our full customer offering, which is designed to help healthcare institutions address the challenges they face in today's ever-changing healthcare environment of expanding healthcare reform initiatives, financial pressures and accelerated hospital consolidation." As healthcare institutions are being challenged to provide quality care in a leaner, more efficient manner, they are seeking partners who deliver smart, cost-saving solutions that maintain the highest standards in clinical excellence. Getinge has refocused its resources to develop and deliver more innovative healthcare solutions that will address its customers' most complex healthcare challenges and ultimately improve the daily lives of patients.

Ganshorn SpiroScout Spirometer Cleared by FDA

The FDA has given Ganshorn Medizin Electronic GmbH good news by giving 510(k) clearance for its SpiroScout Spirometer. The SpiroScout is a complete spirometer based on the unique ultrasonic measurement principle of Ganshorn. But the SpiroScout is much more than just a spirometer. The SpiroScout is the first ultrasonic spirometer to simultaneously measure flow and gas density providing all necessary information about the volume and gas exchange from one single measurement. Other unique features of the SpiroScout are: high precision spirometry due to direct to flow measurement, easy to clean, easy to operate, all ATS/ERS repeatability criteria built-in the software, no perceived resistance increasing patient comfort, teal-time BTPS correction, drift free and highly accurate, and no volume calibration and warm-up time necessary. Ganshorn Medizin Electronic GmbH has been creating innovative medical products in the respiratory field for over 30 years and finally decided in 2016 to bring their innovative pulmonary function product line to the United States. If you would like to find out more information about the SpiroScout or would like to learn more about the Ganshorn technology visit www.ganshorn.us.

New Clinical Symposium

Fisher & Paykel is hosting a symposium on January 22 in Hawaii entitled Optiflow Nasal High Flow: What Really Matters? Hosted in the Hilton Hawaiian Village, Mid-Pacific Tower, Coral 3 Ballroom, the event features guest speakers Dr Nicholas Hill and Dr Francois Stephan. At the end of the session, participants will be able to:

  1. Identify the current evidence for Nasal High Flow (NHF) therapy
  2. Evaluate the emerging and clinically significant applications for NHF therapy
  3. Direct evidence-based process change regarding the use of NHF therapy.

GUEST SPEAKERS

Dr Hill received his MD from Dartmouth Medical School in 1975. He completed a fellowship in Cardiovascular Medicine at the University of Massachusetts Medical Center and in Pulmonary Medicine at Boston University School of Medicine. He has conducted extensive research and published in the fields of noninvasive ventilation and pulmonary hypertension. He is a Past President of the ATS and has received a Distinguished Scholar Award from the Chest Foundation of the American College of Chest Physicians. Dr Stephan earned his fellowship in Anesthesiology and Critical Care Medicine at Assistance Publique-Hôpitaux de Paris in Paris and spent a year in Geneva at the Hôpitaux Universitaires de Genève, Switzerland. Dr Stéphan’s research interests include the understanding and diagnosis of nosocomial infections, mechanisms of thrombocytopenia in the ICU, and improving the care of patients withrespiratory failure. Dr Stéphan has published over 50 peer-reviewed papers. To take part in the event, pease register at nasalhighflowevents@fphcare.com.

Company Invests in New Personalized Product Line

Electromed announced the expansion of its SmartVest SQL Airway Clearance System product line to include new SmartVest garment and SQL generator colors, offering patients with chronic impaired airway clearance more opportunities to personalize their HFCWO therapy experience. The expanded SmartVest garment and SQL generator colors were set to make their debut at the North American Cystic Fibrosis Conference in Orlando, Florida, October 27 – 29. For the SmartVest garment, the company unveiled seven designs, including green camouflage, pink camouflage, and black. The SmartVest features Velcro-like closures, soft-touch fabric, and a single-hose design to make treatment easy and comfortable. As for the SmartVest SQL generator, it's considered the lightest HFCWO generator on the market, and is now available in four unique colors to fit a patient's personal style: blue, red, bright blue, and gray. "The SmartVest and SQL color expansion provides greater customization of one's HFCWO therapy to promote patient satisfaction, which ultimately encourages therapy adherence," commented Kathleen Skarvan, President and Chief Executive Officer of Electromed. "We're proud to stand by our commitment to continued innovation by delivering market-driven HFCWO therapy solutions." With the expansion to seven garment colors and four generator enclosure colors, patients receive a greater opportunity to uniquely customize their SmartVest system. Higher personalization can positively influence satisfaction with therapy and may improve adherence, along with the SmartVest's ease of use, ergonomic comfort, and lifestyle convenience. The new color selection is marketed for domestic homecare use only. The SmartVest system is designed to promote airway clearance and enhance bronchial drainage through high frequency chest wall oscillation (HFCWO), a proven clinical therapy that helps clear the lungs of excess secretions, reducing the risk of respiratory infections and hospitalizations. Airway clearance therapies must be consistently followed to have their intended benefit, and as with any treatment, poor adherence can compromise its effectiveness.

New Research Shows Benefits of Nasal High Flow Therapy

Fisher & Paykel Healthcare welcomes new research on the benefits of its Optiflow nasal high flow therapy. This research will be presented at the American Association of Respiratory Care (AARC) Congress in San Antonio, Texas from October 15-18. Earlier in October, the prestigious Journal of the American Medical Association (JAMA) published another study led by Associate Professor Hernández MD, which investigated the use of nasal high flow (NHF) therapy in comparison to non-invasive ventilation (NIV) for patients at high-risk of reintubation. The randomised clinical trial was conducted across three intensive care units and used Fisher & Paykel Healthcare's Optiflow nasal cannula. The research showed that among high-risk adults who had undergone extubation, NHF was not inferior to NIV for preventing reintubation and post-extubation respiratory failure. The multicentre randomised non-inferiority clinical trial, involving 604 adults in three intensive care units in Spain, found that the proportion requiring reintubation was 22.8% with NHF therapy vs 19.1% with NIV, and post-extubation respiratory failure was observed in 26.9% with NHF vs 39.8% with NIV, reaching the non-inferiority threshold. As secondary outcomes, median time to reintubation was not significantly different in the two groups but median ICU length of stay after randomisation was lower in the NHF group: 3 days vs 4 days. In addition, adverse effects requiring withdrawal of the therapy were observed in none of the patients in the NHF group vs 42.9% of patients in the NIV group. This research follows on from an earlier study in 2016 by Assoc. Prof Hernández and colleagues, which found that the use of Optiflow NHF therapy reduced the risk of escalation for extubated patients within 72 hours when compared to conventional oxygen therapy. The much better comfort and tolerance of NHF compared with NIV, permitting nearly 24 hours of daily use, are significant advantages3 and together, these two studies published by Assoc. Prof Hernández comprise compelling clinical evidence of the benefits of Optiflow NHF therapy.

Intelligent Humidification Presented

As a manufacturer of Intelligent Ventilation solutions, Hamilton Medical provides caregivers with technologies that allow them to focus on the important aspects of patient care. To expand the Intelligent Ventilation concepts to devices directly involved in critical care ventilation was the next logical step. "Humidification is an important part of respiratory care. When we developed the HAMILTON-H900 humidifier, we talked to many clinicians to understand what they would improve in conventional humidification," explains Jens Hallek, President of Hamilton Medical. Easier handling of circuits, cables and connections, an improved user interface, reduction of rain-out, and increased safety were the most requested enhancements. The HAMILTON-H900 aims at improving humidification in exactly these areas. The HAMILTON-H900 comprises only two components, which are delivered pre-assembled and ready to use: The wall-heated breathing set including the new all-in- one connectors, integrated temperature probe, water refill tube, Y-piece, and water chamber, and the humidifier base with the user interface and the heating plate. This saves time, increases efficiency, and facilitates the handling of the humidifier, as well as reducing the risk of contamination. With no need to worry about extra cables to connect or disconnect anymore, the caregiver only needs to slide the water chamber into the humidifier and connect the breathing circuit to the patient. The breathing circuits for the HAMILTON-H900 integrate the heater wires into the circuit wall. This eliminates the cold interface between heated breathing gas and ambient temperatures, and leads to significantly reduced condensation and rain-out effects in the breathing circuit. To perfectly adapt the humidification therapy to the individual patient and environmental conditions, the HAMILTON-H900 humidifier allows for manual adjustment of the chamber temperature and temperature gradient. Having too much condensation in the tubing can, therefore, be avoided by adjusting the temperature gradient. By reducing the need to open the circuit to drain condensate, the HAMILTON-H900 minimizes the potential for the spread of pathogens associated with the development of ventilator-associated pneumonia (VAP). Due to the ergonomic design, the user interface can be easily seen and operated from a standing position, and provides all the information the caregiver needs at a glance. The large, high-contrast LC display provides excellent readability, even in direct sunlight. Alarms are displayed with self-explanatory icons on the LC display, and can be heard and seen from afar thanks to the bright alarm lamps and audible alarm.

Investment Drives Forward for Companies

Clayton, Dubilier & Rice ("CD&R") announced an agreement under which CD&R-managed funds will make a significant equity investment alongside existing management in Drive DeVilbiss Healthcare ("Drive"), a global manufacturer of medical products. Terms of the transaction were not disclosed. Formed in 2000, Drive has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. The company's high-quality, diverse product portfolio, channel footprint and global operating scale were strategically built by its executive leadership team to take advantage of favorable underlying demographic and industry trends. Drive's products include a full suite of mobility, respiratory, sleep, bath and personal care, specialty beds, pressure prevention, rehabilitation and other related products, and are sold into the homecare, long-term care, retail and e-commerce channels. Drive serves a customer base of more than 15,000 dealers, home healthcare providers, healthcare distributors, retailers and e-commerce companies and sells its branded products in more than 80 countries around the world. "Drive's management team has done an exceptional job of identifying and capitalizing on the increasing demand for its products across multiple channels," said CD&R Partner Richard J. Schnall. "We intend to play a constructive role by supporting a very talented management team as it continues to grow the business organically and through acquisitions, pursue operational excellence and serve its customers with the highest quality products." Since 2002, Drive has completed 25 acquisitions that have expanded its product portfolio, geographic reach and manufacturing capabilities. In July 2015, Drive completed the transformational acquisition of DeVilbiss Healthcare, a global manufacturer of respiratory and sleep products. The acquisition provided Drive with a strong platform and a significant cross-selling opportunity in the fast-growing respiratory and sleep market segments, while increasing the company's manufacturing capabilities and its market presence around the world. Since the successful integration of DeVilbiss, Drive has operated under the name of Drive DeVilbiss Healthcare. Derek Strum, CD&R Principal, added: "We believe Drive has substantial runway for continued organic growth given the company's strong value proposition, partnership approach with its customers and significant product breadth. Drive also has a strong pipeline of acquisitions, which should result in continued robust growth in the years ahead." Richard Kolodny, President of Drive, said, "As successful as we have been since our founding in 2000 and with the support we received from Ferrer Freeman & Company over the past eight years, we believe that our growth story is just beginning. With CD&R as our partner, we are confident that we will realize the full potential of the company." CD&R has obtained committed financing from Barclays, JPMorgan Chase Bank, N.A., Citigroup Global Markets, Inc., Capital One, National Association and HSBC Securities (USA) Inc. Barclays, J.P. Morgan Securities LLC and Citi acted as financial advisors and Debevoise & Plimpton LLP acted as legal advisor to CD&R in connection with the transaction, which is expected to close in the fourth quarter of 2016.  Drive's financial advisor was Robert W. Baird & Co., and its legal advisor was Bryan Cave LLP.

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.


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