FEATURES

GO WITH THE FLO
Maxtec, Salt Lake City UT is pleased to announce our new MaxFLO2. The MaxFLO2 provides an affordable method for mixing and monitoring air and oxygen in both high flow (0-50 liters per minute) and low flow (0-10 liters per minute) applications. Each unit comes equipped with dual flow meters and a mixed gas analysis port for intermittent or continuous monitoring of FiO2. When used in conjunction with our MaxO2+A handheld oxygen analyzer, users can mix and measure accurate oxygen concentrations with added confidence. Gas ratios are also visibly identified on the face of the unit to allow for fast, accurate flow settings. Every unit also includes a built-in pole mount and is backed by a Maxtec 24 month warranty. Contact (800) 748.5355, www.maxtecinc.com.

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

DELIVERY
Smiths Medical introduces its new paraPAC plus Oxygen delivery platform. The paraPAC plus gives you the versatility to deliver oxygen therapy, CPAP, demand oxygen and mechanical ventilation all from one compact, lightweight unit. The paraPACTM plus is designed for the most demanding environments: Emergency, Ambulance, Aircraft, Hospital and MRI. This ventilator is tested and approved for these extreme situations to ensure the optimum patient care can be delivered by the user. The paraPAC plus is the latest addition to the Pneupac range offering the reliability you expect, plus: use in MRI scanner to 3 Tesla, built in oxygen therapy facility, CPAP, DEMAND system allowing the patient to breathe with the ventilator, lighter weight, ruggedness, manual breath with Pneupac patented volume limiter, fits to existing Pneupac brackets, luminescent manometer, display of inspiratory and expiratory pressure, integrated PEEP function, air worthiness certification, and hyperinflation accessory for neonatal ventilation. Contact smiths-medical.com.

COLLABORATION
Covidien and GE Healthcare announced a five-year, global collaboration to incorporate Covidien measurement technologies into GE Healthcare patient monitors. The Nellcor Respiratory Function portfolio, which includes Nellcor pulse oximetry with OxiMax Technology, and the BIS Brain Monitoring system, are now available on many GE Healthcare patient monitors. This includes the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. The Covidien collaboration reflects GE Healthcare’s commitment to maintain an open monitoring architecture, bringing together streams of patient data and making it usable for clinicians at the point of care. The collaboration leverages the Covidien portfolio of patient monitoring technologies, including: Nellcor pulse oximetry with OxiMax Technology, a cardiac-based pulse oximetry platform, which accurately monitors patients at all acuity levels and in challenging conditions. The Nellcor pulse oximetry solution from Covidien offers SpO2, Pulse Rate and Respiration Rate in a single sensor design. INVOS Cerebral/Somatic Oximetry monitors site-specific oxygen levels to optimize end-organ perfusion and help protect against devastating major organ morbidity and neurological injury. BIS Brain Monitoring measures the effects of anesthetics and sedatives on the brain. Contact covidien.com or gehealthcare.com.

ACQUISITION
Newport Medical announced that it has signed a definitive agreement to be acquired by Covidien. Covidien designs and manufactures the Puritan Bennett ventilators. Its current product portfolio includes the Puritan Bennett 840 ventilator and the portable Puritan Bennett 540 ventilator. Newport reported that Covidien’s products are an excellent complement to Newport’s ventilation solutions.

CO-OXIMETRY WEBINAR
The Illuminations Webinar Series is presenting New Perspectives on Reducing Pre-analytical Errors: CO-Oximetry Testing, Wednesday, May 9, 11 AM to 12 PM, ET. The speaker is John J. Ancy, MA, RRT, Senior Clinical Consultant, Instrumentation Laboratory, Bedford, MA. Credit is 1.0 Professional Education Program hour through P.A.C.E. and AARC. The program includes: clinical impact of pre-analytical errors on CO-Oximetry testing; evaluation of oxygenation measurement technologies, methods, and measured vs calculated values; identification of critical pre-analytical factors; exploration of the hemoglobin-oxygen relationship; clinical relevance of dyshemoglobins; strategies to identify and reduce error in the POC environment; and case analysis of effective methods for optimizing the pre-analytical phase. This is part two of a three-part series. To register, go to www.ilus.com/illuminations.

APPROVED
Discovery Laboratories, Inc announced that the United States Food and Drug Administration (FDA) has approved SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine. Discovery Labs anticipates that SURFAXIN will be commercially available in the United States in late 2012. The safety and efficacy of SURFAXIN for the prevention of RDS in premature infants was demonstrated in a large, multinational phase 3 clinical program that included 1294 patients. For more visit www.surfaxin.com

INNOVATIVE PRODUCTS
Respiralogics, based in San Marcos, CA and owned and operated by the management team of David Thompson and Beth Keifer, collectively brings more than 60 years of clinical, educational and technical expertise in the critical care field. The longtime partners’ goal is to free clinicians to focus on patient care. The company’s suite of products focuses on the respiratory care field. Respiralogics’ product line includes: Babi.Plus Bubble nCPAP System for delivery of non-invasive respiratory support for premature and small infants; Sil.Flex Stoma Pad and Sil.Flex TC Pad, ergonomically designed cushions intended to redistribute pressure at stoma sites, improving patient comfort and minimizing skin breakdown; Danny Ties, unique tracheostomy tube holders with a softer and more comfortable fit around the neck for patients of all ages; and Venti.Plus Test Lungs and Babi.Plus nTest Lung, great tools to simulate the respiratory system that demonstrate mechanical ventilator applications and perform ventilator circuit testing prior to clinical use. (Babi.Plus, Sil.Flex and Venti.Plus are trademarks of A Plus Medical. Danny Ties is a trademark of Leckie Medical Products, Inc.) Visit www.respiralogics.com.

LAWSUIT
Newport Medical Instruments Inc announced that it filed a patent infringement lawsuit in the US District Court for the Middle District of Florida against Flight Medical Innovations Ltd of Israel. The suit claims that Flight Medical’s Flight 60 ventilator infringes upon a US patent owned by Newport Medical. "In our 30 year history, we have never filed a lawsuit. We had hoped to avoid litigation altogether”, stated Hong-Lin Du, MD, President of Newport Medical. “Unfortunately, Flight Medical gave us no choice but to file this lawsuit in order to protect our valuable intellectual property rights." Newport Medical is a privately owned company based in Costa Mesa, CA. Newport ventilators, designed for use in hospitals, sub-acute facilities, medical transportation and homecare, are distributed in over 116 countries.

TRANSPORT CLEARANCE
Dräger has received FDA 510(k) Clearance for Oxylog 3000 plus Emergency Transport Ventilator. With the Oxylog 3000 plus, critically ill or injured patients can be ventilated whether they are in emergency situations, during air-ambulance transport, or intra-hospital. New features previously only found on intensive care ventilators such as AutoFlow and integrated capnography are now available during transport. Dräger continues its leadership in advanced mechanical ventilation with the release of the Oxylog 3000 plus. A full range of ventilation modes such as VC-CMV, VC-AC, VC-SIMV, SPN-CPAP, PC-SIMV+, and now the addition of AutoFlow offers clinicians the continuity of care when transporting outside of the ICU. AutoFlow also allows for spontaneous breathing at the lowest inspiratory pressures as it takes the patient’s lung mechanics into account when delivering ventilatory support. Integrated capnography is now an available option with the Oxylog 3000 plus. For field clinicians, this can be an invaluable tool to recognize proper airway placement, as well as the ability to monitor a patient’s change in metabolism especially in confined spaces such as the air ambulance. The Oxylog 3000 plus is making its debut in the United States at the annual congress of the AARC on November 5th in Tampa, FL. For more information, please contact Draeger Medical, Inc at (800) 437-2437 or email at info.usa@draeger.com.

APPROVED
3B Products, LLC announced FDA approval of its 3B Flex-Lite nasal mask, a light, flexible and comfortable alternative to standard CPAP masks. The Flex-Lite, patterned on a cannula design, comes with multiple sized nasal pillows for a perfect fit and increased patient compliance. The cannula design is often preferable for patients unable to tolerate standard 22mm CPAP air tubing on or near the face. Comfortable for both back and side sleepers. Contact 3Bproducts.com.

PETITIONED
FDA petitioned to retract pediatric extension for Ikaria’s INOmax nitric oxide product:  The US Department of Health and Human Services has been sent a Citizen Petition requesting that the Food and Drug Administration rescind the Pediatric Exclusivity extension approved for Ikaria in 2010 that extends their patent protection for their nitric oxide gas for six months beyond the US patent expiration date. The Pediatric Exclusivity Statute was designed to give extended protection to pharmaceutical companies that perform new pediatric studies at the request of the FDA. FDA documents disclosed that Ikaria first approached the FDA in April of 2008 requesting that the FDA write them a letter requesting additional studies for INOmax nitric oxide gas to study the effects on premature infants to prevent BPD.1 Ikaria submitted three studies, two of which were statistically negative trials, to fulfill the requirements of the Statute. The third study demonstrated a statistical benefit, however the FDA found that because of issues raised by their analysis (data quality, different post hoc statistical analyses, and lack of p value adjustments for interim analyses), the statistical determination was difficult to discern.2 However, the Pediatric Exclusivity Guidance Document specifically states that, “FDA does not believe it would be consistent with the intent of the statute to accept data collected prior to the Written Request if such data are already known to provide no useful information.”3 The petitioner cited the irregularity of the Ikaria request in that all three studies were completed by March of 2008, two of which were completed in 2005. Therefore, at the time of the Ikaria letter to the FDA and the subsequent FDA letter to Ikaria, the data from the negative trials had been collected (two of the trials were published in 2006)4,5 and therefore as negative trials, should never have been submitted or accepted by the FDA in applying for coverage by this statute. The petitioner argued that this extension granted to Ikaria prevents generic suppliers of pharmaceutical nitric oxide gas from entering the market. The petitioner expects that the FDA will review their granting of the Pediatric Exclusivity and hopefully open the market to generic competition six months earlier, potentially saving the US healthcare system tens of millions of dollars in that period. [Footnotes: 1. Curtis J. Rosebraugh, Department of Health and Human Services, Food and Drug Administration, Written Request, IND 106088, NDA 020845, Application Type: GI-1, Ino Therapeutics Inc., 04/30/2010. 2. Medical Officer Review, Division of Pulmonary, Allergy and Rheumatology Drug Products (HFD-570), Application #: 20-845, Proprietary Name: INOmax, Review Date: November 19, 2010. 3. Guidance for Industry, Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act,  U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Revised, September 1999. 4. Kinsella JP, et al. Early Inhaled Nitric Oxide Therapy in Premature Newborns with Respiratory Failure. N Engl J Med 2006;355:354-64. 5. Ballard RA, et al.  Inhaled Nitric Oxide in Preterm Infants Undergoing Mechanical Ventilation.  N Engl J Med 2006;355:343-53.

PRESSURE MONITOR
VORTRAN Medical Technology 1, Inc introduced the VORTRAN-APM (Airway Pressure Monitor), MSRP $425. The VORTRAN-APM, battery operated device connects to the patient through connection tubing to monitor conditions of resuscitators, like the VAR (VORTRAN Automatic Resuscitator). The APM is available for both pediatric and adult patients with differing alarm limits. The APM displays PIP, PEEP, Respiratory Rate, Inspiratory and Expiratory Time, and I:E Ratio. The APM provides NON-CYCLING, HIGH RATE, and HIGH PIP alarms with predetermined limits. The APM has audible alarms and a flashing red LED, with alarm conditions displayed on a LCD screen. Contact www.vortran.com.

PARTNERING
Hamilton Medical and Rega are joining together, with Hamilton’s recently-launched HAMILTON T1 mobile ventilator to be used on Rega’s fleet of air ambulances. Rega is the first air rescue service in the world to equip their fleet of air ambulances with this advanced mobile intensive care ventilator HAMILTON-T1 as launching partner. The HAMILTON-T1 ventilator features a compact, powerful design that increases the availability of appropriate modes of therapy for ventilated intensive care patients outside the hospital. It covers the full range of clinical requirements: invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV) – invented by Hamilton Medical, and non-invasive ventilation (NIV). This portable transportation platform is appropriate for all patients, from pediatric to adult. Hamilton manufactures al its products at its green manufacturing facility in Switzerland. Contact www.hamilton-medical.com.

REVEILLE
CareFusion announced the launch of the ReVel ventilator, a new high performance, portable device designed for pediatric to adult (min 5Kg) patients who require breathing support during transport. The ReVel ventilator is a complementary addition to CareFusion’s Alternate Care portfolio, including emergency and military respiratory care, which is focused on helping clinicians improve patient care, optimizing ventilator therapy and reducing costs. Specifically, the ReVel has the capability to manage the most critical, intubated and non-invasively ventilated patients from the initial point of emergency, during transport and through the hospital allowing for potentially lifesaving ventilation during transport. The ReVel weighs 9.5 pounds compared to the typical 20+ pound systems. Its small size and ergonomic design mounts easily in ground and air emergency vehicles, including ambulances, helicopters and military aircraft. The ReVel allows clinicians to provide pediatric and adult patients with the highest level of care with a light-weight and portable system through the continuum of care. It also provides monitoring and clinical tools to assist clinicians in best managing and caring for patients in hospital or alternate care facilities. Its Spontaneous Breathing Trial (SBT) technology provides data to help clinicians decide when to safely wean patients from ventilation. The device also features an integrated pulse oximeter to monitor a patient's pulse rate and oxygen saturation level during transport situations in lieu of costly additional equipment. Contact carefusion.com/revel.

INTEGRATED
Maquet Critical Care and Aerogen, Ireland, have announced the release of their partnered product, an integrated unit which provides state of the art nebulizers for the Maquet SERVO-i ventilator.  Maquet has been a long term distribution partner for Aerogen. Maquet and Aerogen have jointly created this product which can fit neatly into the Maquet ventilator, enabling the user to benefit from the advanced Aerogen OnQ micropump technology. The Aerogen technology in the form of the Aeroneb Solo nebulizer allows drugs to be nebulized into a fine particle mist that can be absorbed through the lungs while maintaining drug integrity. The aerosol is based on a vibrating mesh which, when powered, acts as a micropump creating predictable sized droplets enabling targeted drug delivery to the lungs. The technology offers an alternative to the existing nebulizer offerings, this unique technology allows for the caregiver to nebulize suspensions and solutions, without heating or degrading the drug. Recently, Aerogen began work on an integrated solution for the SERVO-i ventilator, which will enable users to replace the existing nebulizer with the high efficiency Aeroneb nebulizer. The integration will enable caregivers to control the Aeroneb nebulizer directly from the user interface, providing ability to nebulize in both intermittent and continuous modes. The integrated product is available to new SERVO-i customers and can be retrofitted into the SERVO-i’s currently in use. The Aerogen integration is available for purchase through Maquet dealers. The unit can be installed before purchase or retro-fitted by a Maquet service engineer.

TREATMENT APPROVED
Novartis announced that the FDA has approved once-daily Arcapta Neohaler (indacaterol inhalation powder) 75 mcg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma. The decision makes Arcapta, formerly known as QAB149, the first once-daily therapy in the long-acting beta2-agonist (LABA) class to be approved in the US for maintenance treatment of airflow obstruction in COPD patients. Arcapta 75 mcg was studied in 641 COPD patients in two key Phase III trials lasting 12 weeks. Results at week 12 showed that Arcapta significantly improved lung function at 24 hours compared to placebo. Lung function improvements were seen five minutes after the first dose and consistently maintained over 12 weeks. Arcapta also significantly reduced the need for patients to use daily rescue medication. Additionally, Arcapta improved health-related quality of life compared to placebo, as measured with the St George’s Respiratory Questionnaire (SGRQ). The SGRQ is widely used in clinical trials to measure symptoms, activities, and impact of COPD on daily life as reported by patients. The clinical trial program supporting US submission evaluated safety in 2,516 patients who received Arcapta for at least 12 weeks at doses of 75 mcg or more, with results supporting the safety and tolerability profile of Arcapta. The most common adverse reactions in 449 patients taking Arcapta 75 mcg (ie those reported in more than 2% of patients and with higher incidence than placebo) were cough, nasopharyngitis, headache, nausea, and oropharyngeal pain. Contact www.novartis.com.

SAFE AND CONTINUOUS
Aerogen of Galway, Ireland, has launched a new syringe and tube-set that enables medical personnel to safely continuously nebulize a patient by completely eliminating the danger of tubing misconnections. Luer connector systems, common to many healthcare catheters, tubes, administration sets, extension sets, and syringes, have been at the heart of many catheter/tubing misconnections. The ease of connection between these luer lock connectors have led to misconnections that have inadvertently linked unrelated systems, and at times, have resulted in serious adverse events. Until now, this risk was inherent in continuous nebulization set-ups. Aerogen’s new continuous nebulization tube set incorporates non-standard connectors that cannot be misconnected onto any other device being used with the patient. The new tube set is compliant with the European Harmonised Standard EN 13455-1 and with the FDA guidelines on prevention of tubing misconnections. Contact www.aerogen.com, or Tri-anim, Aerogen’s US distributor.

REINTUBATION & SURFACTANT
Discovery Laboratories, Inc announced that the Journal of Neonatal-Perinatal Medicine recently published a manuscript reviewing an important data analysis from the Surfaxin (lucinactant) Phase 3 clinical trial program. The manuscript is entitled “Reintubation and risk of morbidity and mortality in preterm infants after surfactant replacement therapy” (Guardia et al, Volume 4, Number 2, 2011). This is the first peer-reviewed manuscript describing neonatal patient compromise following reintubation.The analysis demonstrates that, for preterm infants at risk for respiratory distress syndrome (RDS) who received prophylactic surfactant therapy and were extubated, subsequent reintubation is a highly predictive risk factor for mortality and major complications of prematurity. The analysis also indicates that infants treated with Surfaxin had a significantly lower incidence of subsequent reintubation and improved survival without reintubation, compared with infants who received animal-derived surfactants Survanta (beractant) and Curosurf (poractant alfa), the current standard of care. Infants who are extubated following surfactant therapy often relapse and require reintubation. Although increased mortality and morbidity in adults requiring reintubation is well described in medical literature, the consequences of reintubation in preterm infants have not been previously reported. Data from Discovery Labs’ Phase 3 RDS clinical trials were assessed in a post-hoc analysis to evaluate the consequences of reintubation as well as the potential effect of surfactant choice on reintubation rates and subsequent clinical outcomes in preterm infants. The recently published manuscript highlights the following observations: Infants who were successfully extubated and did not require reintubation experienced low mortality rates across all treatment groups, while infants who were subsequently reintubated had a statistically significant higher mortality rate, 0.5% vs. 18%, respectively (p < 0.05). Infants who required reintubation had significantly higher rates of six major complications of prematurity, including BPD, necrotizing enterocolitis, sepsis, and intraventricular hemorrhage. Infants treated with Surfaxin demonstrated a significantly lower reintubation rate compared with those infants treated with animal-derived surfactants, Curosurf (33% vs. 47% respectively; p < 0.05) and Survanta (35% vs 43% respectively; p < 0.05). Infants treated with Surfaxin demonstrated a significantly higher combined outcome of survival without reintubation compared with those infants treated with animal-derived surfactants, Curosurf (67% vs 53% respectively; p < 0.05) and Survanta (65% vs 57% respectively; p < 0.05). Surfaxin is an investigational drug product that has not been approved by the FDA or any other world health regulatory authority. Top-line data of this post-hoc analysis was previously presented at the 2008 AARC. International Respiratory Congress. Contact www.discoverylabs.com.

TRAVEL-FRIENDLY
Healthcare providers in the US whose patients require a reliable supply of oxygen while traveling by air, train or automobile now have access to a 24-hour oxygen travel service while traveling anywhere in the world. Using the travel-friendly and clinically sound oxygen supply system from Chart SeQual Technologies Inc, the Linde Eclipse portable oxygen concentrator is now available in the from LifeGas, the medical gases business of Linde North America. LifeGas provides a full line of medical and quality critical gases and equipment to over 1,000 hospitals, clinics, nursing facilities, emergency management services and home healthcare providers. The Linde Eclipse portable oxygen concentrator is an advanced travel oxygen delivery system developed by Chart SeQual Technologies Inc, a San Diego-based medical device manufacturer. The Linde Eclipse portable oxygen concentrator comes with a sleek carbon graphite look and feel, and is custom packaged for Linde in a plastic corrugated case intended for repeat courier shipments. The Linde unit is equipped with standard Eclipse accessories, including the universal cart that allows battery access while attached to the Linde Eclipse portable oxygen concentrator, AC and DC power supplies, a power cartridge, and an accessory bag. With continuous flow settings up to three liters per minute and pulse dosing up to 192 milliliters per bolus, the Linde Eclipse portable oxygen concentrator also utilizes Chart SeQual Technologies’ well-known autoSATTM technology. The Linde Eclipse portable oxygen concentrator is a 24/7 device meeting stationary, ambulatory and travel needs. Visit www.sequal.com or www.us.lindegas.com or www.lifegas.com.

SATISFACTION GUARANTEED
Hamilton Medical’s ventilation systems have earned the top User Satisfaction Ratings in all categories in MD Buyline’s Quarterly User Satisfaction Report. Hamilton Medical, Inc is entering its third year holding the top composite score in ventilation as rated by the clinical members of MD Buyline. Hamilton Medical, Inc continues to stand behind the quality of its ventilation technology products and it is passing its commitment to continued superior performance along to our customers. Beginning January 2011, all new ventilation systems purchased from Hamilton Medical, Inc will have a one year labor and three year parts warranty included standard on every system. Contact www.hamilton-medical.com, (800) 426-6331.

HOME WORK
CareFusion has introduced a portable ventilator for adults and children who require mechanical ventilation at home. The CareFusion LTV 1100 ventilator is designed to significantly enhance the mobility of patients with spinal injuries or neuro-muscular diseases who require continuous ventilation to breathe. The LTV1100 ventilator offers features common to ventilators used in hospital intensive care units, but in a small, easy-to-use, durable package for patient and caregivers. The system enables all-day portability for active, ambulatory patients in vehicles, wheelchairs, walkers or scooters, or can be attached to a wall, bedside table or patient gurney. For patients with chronic ventilatory failure, the LTV 1100 ventilator enables non-invasive positive pressure ventilation, an approach reported to reduce the risk of respiratory infection, improve voice function and enhance quality of life.  The LTV 1100 ventilator also features a spontaneous breathing trial (SBT) mode, which uses a rapid shallow breathing index to evaluate a patient’s readiness to be weaned off of the ventilator. Clinicians can customize the SBT setting to individual patients, ensuring optimal levels of support as patients are tested on their required level of breathing support.  Contact www.carefusion.com.

PRODUCT LAUNCH
Pharmaxis announced the commercial launch of ARIDOL (mannitol inhalation powder) Bronchial Challenge Test Kit, the first new bronchial challenge test in more than two decades and the company’s first product launch in the US. ARIDOL is used to assess bronchial hyperresponsiveness in patients six years of age and older who do not have clinically apparent asthma. ARIDOL is a single-use, indirect test that takes about 20 minutes to administer, requires minimal preparation time and a 15% reduction in lung function from baseline for a positive test. The ARIDOL test requires patients to inhale increasing doses of dry powder mannitol from a simple, hand-held device, which causes airways to narrow and contract when airway inflammation is present. The doses are contained in capsules that are administered at one-minute intervals until a positive response is achieved or until all the capsules have been inhaled, indicating a negative result. A positive response is indicated when there is a 15% reduction in lung function from baseline compared to a 20% fall required by a methacholine challenge test. The safety and efficacy of ARIDOL as a bronchial challenge test were verified in two global Phase III clinical trials. Contact www.pharmaxis.com.

TWO FROM SMITHS
The babyPAC emergency and transport ventilator from Smiths Medical is MRI compatible and allows for precise oxygen concentrations. Its variable gas mixing system extends cylinder life and allows precise selection of oxygen concentration. Calibrated inspiratory pressure control provides continuous adjustment of the end inspiratory pressure. Separate controls provide careful management of inspiratory/expiratory time and pressure to suit patient breathing requirements. It ,as four operating modes: CMV+PEEP; CMV+ Active PEEP, IMV+CPAP and CPAP. Adjustable pneumatic pressure relief with alarm provides a wide range of options. Dual function PEEP/CPAP control allows continuous adjustment of  pressure... The Pneupac VR1 emergency ventilator offers a single control for setting the frequency  and tidal volume, including a clock-stop setting at the recommended adult position. This portable ventilator enables rapid setup in demanding circumstances. Auto /manual controls, a patient demand system, MR compatibility, and other features provide the means to manage respiratory emergencies. Its oxygen powered unit eliminates the need for electricity. Linked manual controls allow it to be used in a variety of chest compression and ventilation options in cardiac life support. MR compatibility provides maximum flexibility for transport within the hospital. Contact www.smiths-medical.com/pneupac.

CLASSIFIED ADS NOW AVAILABLE ON THIS WEBSITE!
Respiratory Therapy is now accepting JOB LISTINGS on this website, for healthcare institutions seeking employees, including respiratory therapists, respiratory care nurses, sleep therapists, or any relevant positions. For details on this opportunity, please click on the Classified Advertising Information menu above. For further inquiries, please contact the publisher at s.gold4@verizon.net.

NEW PLATFORMS
Covidien announced that three new platforms for its Puritan Bennett 840 ventilator — the Puritan Bennett 840 Neonatal ventilator, the Puritan Bennett 840 Universal ventilator and the Puritan Bennett 840 Pediatric-Adult ventilator — are now available in the United States.  The Puritan Bennett 840 Neonatal ventilator helps clinicians safely deliver, manage and monitor a ventilation regimen tailored for even the smallest and most critically ill neonatal patients. It offers the ability to set a tidal volume as small as 2 mL for neonates weighing as little as 300 grams without having to change to another ventilator. The Puritan Bennett 840 Universal ventilator for every patient type, from neonatal to adult, includes a neonatal CPAP mode that enables clinicians to flexibly deploy noninvasive ventilation in neonates. It supports patient-ventilator synchrony, which has been shown to facilitate spontaneous breathing. The ventilator includes features that effectively match the patient’s respiratory demand and adapt to changes in patient condition. The Puritan Bennett 840 Pediatric-Adult ventilator for pediatric to adult patients helps clinicians provide improved levels of ventilatory support by offering multiple therapies of ventilation, including invasive and noninvasive methods, as well as more advanced modes of ventilation.* [* Xirouchaki N, Kondili E, Vaporidi K, et al. Proportional assist ventilation with load-adjustable gain factors in critically ill patients: comparison with pressure support. Intensive Care Med. 2008; 34(11):2026-2034; Alotaibi G, Kacmarek R, Scanlan C.  Comparison of dual mode ventilation among selected adult critical care ventilators using a programmable lung simulator. Respir Care. 2004. (Abstract).] Contact www.covidien.com.

ACQUISITION
RoundTable Healthcare Partners, a healthcare industry private equity firm, has acquired a majority interest in Salter Labs, which was founded in 1976 by Peter Salter. Salter is a manufacturer of disposable respiratory and sleep diagnostic products for homecare and acute care markets. Salter is RoundTable’s first platform investment. It manages $1.9 billion in capital. More info can be found at www.roundtablehp.com. Salter Labs develops, manufactures and sells single-use, disposable products for homecare and hospitals, and holds 31 patents, with numerous patent applications pending. Contact www.salterlabs.com

Name Change
Sleep Solutions, the pioneer and largest national service provider of home sleep tests for obstructive sleep apnea (OSA), has changed its name to NovaSom, Inc, a Delaware corporation. The company changed its name to better reflect its history and commitment to providing the most accurate and cost effective home tests on the market for the diagnosis of obstructive sleep apnea (OSA). Historically, expensive and uncomfortable laboratory testing has been a barrier to diagnosis for many patients. Now the NovaSom Home Sleep Test provides affordable testing in the privacy and comfort of the person’s natural sleep environment, making it easier for people at risk of OSA to be tested. NovaSom provides sequential night testing which overcomes the single night snapshot of traditional test methods, for a more accurate picture of sleep disordered breathing patterns. The company provide the resources that primary care physicians need to identify people at risk for OSA and determine appropriate candidates for both in-home and laboratory tests. NovaSom has a field-based medical education force and have made significant investments in CME and non-CME educational programs aimed at primary care. It has a large client care team and offers live clinical/technical support, 24 hours a day, 7 days a week, to patients undergoing the home sleep test. The company continues to actively partner with insurance companies to ensure widespread access to NovaSom diagnostic services. Medicare and most major payers cover the test. NovaSom is a Medicare-approved Independent Diagnostic Testing Facility (IDTF) and is fully accredited as an Ambulatory Care Sleep Diagnostic Center by The Joint Commission. The home testing system manufactured and distributed by NovaSom has FDA clearance for the diagnostic evaluation of OSA in adults. Contact www.sleepsolutions.com.

Sleep Support
Philips Respironics and biopharmaceutical company, Cephalon Inc are supporting efforts  to bring untreated sleep apnea to the forefront of discussion among primary care physicians (PCP). As the program enters its second year, Cephalon joins the device makers in responding to educational grant requests to fund a series of independent continuing medical education (CME) activities on this important topic. The education providers' goal of educating 7,200 clinicians was surpassed in the first year with more than 7,800 participants. Prior to participating in the program, 40% of surveyed clinicians felt confident in recognizing the signs and symptoms of sleep apnea. After participating in the CME program, 85% felt confident in their ability to assess and recognize sleep apnea signs and symptoms.  For the new program year, the educational activities have expanded to 24 US cities. The first series of OSA CME activities will be conducted at Primary Care Education's Best Practices in Primary Care, accredited by Primary Care Network. OSA education will also be conducted at Pri-Med's Conference & Exhibitions with those programs accredited by pmiCME. The programs run from October 2010 through June 2011. This year's goal is to educate 10,200 clinicians. The activities have been designed with the objective of improving understanding in identifying, treating and managing patients with OSA. They are available to primary care, family practice and internal medicine physicians, nurse practitioners and physician assistants. [Source: Young T, Peppard E, and Gottlieb D. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med 2002; 165:1217-1239.] For information about Primary Care Education's Best Practices program contact www.primarycareed.com or call (877) 594-1770. For Pri-Med's Conference & Exhibitions contact www.pri-med.com or call (877) 263-5127., or contact resmed.com, philips.com, or cephalon.com.

Memorial Scholarship
SUNY Upstate Medical University alumnus, Robert Councilman, RRT ('85) passed away suddenly at age 46 due to a massive heart attack.  A memorial scholarship was established through the help of his long-time friend and fellow alumnus Ed Coombs, MA RRT-NPS, director of marketing for Respiratory Care Systems at Dräger Medical, Inc and Joseph Sorbello, MSEd, RT, RRT, chair of the Department of Respiratory Therapy Education at SUNY Upstate. Dräger assisted this scholarship drive through a monetary donation to the Foundation for Upstate Medical University Health Professions Alumni Association. Joseph Sorbello commented, "The gift will help promising students while remembering Bob as compassionate patient advocate." The scholarship is scheduled to be given to a deserving student in September 2011. For more information, please contact the Foundation for Upstate and the Health Professions Alumni Association at (315) 464-4416 or www.foundationforupstate.org/chpalumni.

Fleet
Dräger has made available to its customers a fleet of Evita XL ventilators that can be rented under a short term or long term agreement. Whether the need is due to an acute increase in patient census or for continuous use, Dräger can now help better serve the needs of its ventilation customers. The rental fleet of Evita XL ventilators will be delivered with the latest software platform to ensure customers have the newest technology. Contact (800) 437-2437, info.usa@draeger.com.

FDA Clearance
Instrumentation Laboratory (IL) announced that it has received clearance from the FDA to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns. The new tBili assay is performed on IL's GEM Premier 4000 critical care analyzer. It allows clinicians to receive lab-quality test results in 90 seconds from whole blood in the Neonatal Intensive Care Unit (NICU), rather than waiting up to an hour for results from the lab, using traditional chemistry methods. tBili assays performed on the GEM Premier 4000 are not affected by moderate turbidity or hemolysis, ensuring accuracy. Additionally, from a single whole blood sample, a full range of analytes can be measured, including Blood Gas, Electrolytes, Glucose, Lactate and full CO-Oximetry, for an efficient and comprehensive assessment of patient status. IL announced the FDA clearance of the tBili assay at the Annual Meeting of the American Association for Clinical Chemistry in Anaheim, CA. At the meeting, IL also introduced GEMweb Plus Custom Connectivity, software for automated information management. GEMweb Plus is the only software to provide system-wide, bi-directional capabilities from any networked PC of GEM Premier 4000 analyzer. GEMweb Plus provides complete control of all networked analyzers, regardless of location, to enhance quality assurance and regulatory compliance. GEM Premier 4000 critical care analyzer provides blood gas, electrolyte and metabolite analysis with integrated CO-Oximetry testing. It features IL's patented Intelligent Quality Management (iQM), a real-time, automated, quality assurance system that continuously detects, corrects and documents, to assure quality results and compliance, 24/7, regardless of operator or testing location. iQM, coupled with its cartridge-based technology and ease of use, allows the GEM Premier 4000 analyzer to provide consistent, accurate, lab-quality results throughout the hospital. Products mentioned above are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies. Contact www.ilus.com.

FDA Approval
Epocal, Inc, a leading edge provider of point of care technology, announced today that it has received US Food and Drug Administration (FDA) clearance to market its new lactate test on the epoc Blood Analysis System. Lactate measurements from the epoc System are used to evaluate acid-base status and for diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). The addition of lactate to the epoc BGEM Test Card, which includes in vitro diagnostic tests for pH, pO2, pCO2, Na, K, iCa, Hct and Glu (plus calculated values), further expands the clinical utility of the company's point of care blood gas and electrolyte platform. Lactate on the BGEM Test Card represents the second metabolite cleared for use on the epoc System in the past 12 months. It is also the ninth measured analyte on the single-use test card, surpassing most competitive point of care systems which may require multiple test devices in order to match the same menu. Epocal, Inc develops, manufactures and markets the epoc Blood Analysis System. epoc (enterprise point of care) is healthcare's first cost effective point of care testing solution to leverage SmartCard technology and the power of wireless communication to provide critical caregivers with real-time, laboratory quality test results at the patient's bedside. Contact www.epocal.com.

Comprehensive Education
Teleflex Medical announced the introduction of a comprehensive education program in respiratory therapy, designed to provide an in-depth curriculum focused on maximizing humidification and minimizing challenges through the therapeutic levels outlined in the Respiratory Pyramid of Care. The courses are accredited by the American Association for Respiratory Care (AARC). The program's four modules cover humidification basics, passive humidification, active humidification and navigating the Respiratory Pyramid of Care and its five therapeutic levels that form the basis for effective, informed management of patients who require oxygen therapy and/or ventilatory support. Through the sponsorship of Teleflex Medical, an expert panel of respiratory therapy thought leaders was assembled to form the Council for Advances in Respiratory Therapy. Clinical contributors from this group were charged with the development of the content for this education curriculum based upon an extensive literature review to summarize current evidence and best practices. The program is designed to provide practical solutions for clinicians and joins other clinical education offerings from Teleflex Medical, including programs for vessel health and preservation and regional anesthesia best practices. Contact teleflexmedical.com

Siemens RAPIDLab® 1200
Siemens RAPIDLab® 1200 series of blood gas analyzers offers neonatal bilirubin (nBili) point of care testing with 60 second turnaround time,detects elevated levels of bilirubin. If undetected, this condition can lead to a variety of health issues in newborn infants, from jaundice to neurological disorders, and in severe cases, brain damage.

Siemens neonatal bilirubin (nBili) test requires 100uL sample of whole blood, measuring 2 - 30 mgdl and does not require any sample preparation, while providing fast and accurate results and does not increase monthly operating costs. Siemens RAPIDLab systems, nBili testing is conducted as part of a neonatal test panel that includes blood gas, pH, electrolytes, metabolites, total hemoglobin and CO-oximetry, with no additional reagents needed for nBili testing. For additional information, visit www.usa.siemens.com/bloodgas.