d04a1.jpg (11248 bytes)Respironics Announces New Sleep Diagnostic Device
Respironics Inc, Pittsburgh, recently announced the US and international market launch of its new, high-performance Stardust™ Sleep Diagnostic Device, a powerful, seven-channel, three-sensor, portable sleep diagnostic tool. The product can be used in both the home and sleep laboratory and has a wide range of patient applications for screening and diagnosing sleep disordered breathing. It was designed to be one of the smallest, lightest, and most comfortable sleep recorders in the sleep diagnostic marketplace.

The Stardust Recorder is worn on the patient’s chest and records physiological data while he or she sleeps. Three sensors plug directly into the recorder, allowing patients more freedom of movement while they sleep compared to the more traditional, larger sleep diagnostic units. The sleep data are then downloaded and analyzed by Stardust’s host software. The software is based on Alice® 4 technology that is used in Respironics’ more sophisticated sleep laboratory systems.

“The simplicity of Stardust allows health care providers the flexibility to send the unit home with patients for initial sleep studies or follow-up studies to ensure compliance,” comments John Miclot, Respironics’ home care division president. “Our small, lightweight diagnostic equipment frees the patient from bulky large recorders, allowing a more natural sleep to take place while the study is being performed. The Stardust Sleep Diagnostic Device enhances Respironics’ leadership in developing innovative technologies and programs,” Miclot concludes. (800) 962-1266; www.respironics.com

d04b.jpg (12337 bytes)Aerogen Appoints James B. Fink, MS, RRT, FAARC, Director of Respiratory Programs
AeroGen Inc, Sunnyvale, Calif, a privately held company, announced the appointment of James B. Fink, MS, RRT, FAARC, as director of respiratory programs. Fink was previously the administrative analyst of medical services at Hines Veterans Affairs Hospital and a research associate in the Department of Pulmonary and Critical Medicine at Loyola University Stritch School of Medicine, Chicago.

“Jim’s expertise in the field of respiratory medicine and his 25 years of management and administrative experience make him an extremely valuable addition to the AeroGen management team,” says Jane E. Shaw, MD, AeroGen’s chairman and CEO. “His extensive involvement in the study of aerosols and their implication in the treatment of asthma and other chronic lung diseases is a perfect fit for the important work we are doing at AeroGen in developing improved pulmonary drug delivery products for respiratory and systemic therapies.”

While at the Hines VA Hospital, Fink established an aerosol research laboratory, in collaboration with Loyola University, resulting in publication of original research, as well as numerous reviews, chapters, and textbooks associated with clinical aerosol medicine. Fink has been involved in the development of evidence-based clinical practice guidelines on aerosols for both the American Association for Respiratory Care and the American College of Chest Physicians as a member of the Science and Health Policy Committee. He is currently chairman of the Chicago Asthma Consortium and also participated in writing the system-wide Clinical Practice Guidelines for Management of COPD and Asthma for the Department of Veterans Affairs and subsequently a collaborative revision with the Department of Defense. www.aerogen.com.

Masimo Receives FDA Clearance
Masimo Corp, Irvine, Calif, announced that it has received clearance from the Food and Drug Administration (FDA) to expand the indications for use for its Radical Signal Extraction pulse oximeter to include mobile environments. Masimo SET® is the first technology ever to receive FDA clearance for accurate monitoring under conditions of patient motion and low perfusion, on all patient populations, including adults, children, and neonates. The Masimo SET technology’s ability to work under motion and other challenging conditions makes it the ideal technology for mobile environments.

Masimo SET is the only pulse oximetry technology that has been clinically proven accurate in more than 20 independent, peer-reviewed clinical studies to work under motion artifact, low perfusion, and when it is needed the most. These published studies concluded that Masimo SET pulse oximetry exhibits far fewer false alarms and failures, while being more reliable in detecting true alarms.

The Radical Signal Extraction pulse oximeter is three pulse oximeters in one—a stand-alone device for bedside monitoring, a detachable handheld unit for easy portable monitoring, and a monitor interface to upgrade existing multi-parameter patient monitors to Masimo SET technology. Radical can provide continuous and reliable arterial oxygen saturation monitoring anywhere throughout the continuum of care, including emergency medical services, during transport, and in the emergency department, operating room, intensive care unit, recovery room, home, any specialty clinic, the general floor, and mobile environments.

Radical’s unique upgrade capability gives clinicians a quick, easy, and affordable way to upgrade their existing conventional pulse oximeters to Masimo SET performance. The existing upgrade option for most multi-parameter monitors is to purchase an additional upgrade module. Radical’s Satshare™ feature allows the upgrade to be done through the standard patient cable input without the additional module. This plug and play method will save hospitals time and as much as $2,000 for each unit. (877) 4-MASIMO; www.masimo.com.

3Ci Signs Two Respiratory Deals
3Ci, Norcross, Ga, recently signed two exclusive 4-year agreements in the areas of sleep disorders and cystic fibrosis (CF) care.
The first agreement, with Breathing Disorder Services Inc, Oklahoma City, involves StartSmart LLC, a turnkey diagnostic sleep program that addresses one of the country’s most persistent yet misunderstood maladies—sleep disorders. Developed by nationally known sleep diagnostic expert Andrew Macias, RPSGT, StartSmart allows hospitals and clinics to set up their own sleep diagnostic departments without incurring huge capital and labor expenditures.

The company provides up to 2 weeks of in-depth training on polysomnography, along with all necessary policies, procedures, job descriptions, marketing materials, and education on reimbursement issues. Sleep diagnostic instrumentation is available for purchase, lease, or rental.

StartSmart also offers real-time analyses of locally conducted sleep studies by a crew of registered polysomnographic technologists. RPSGTs access the local sleep center’s studies via the Internet, conduct the scoring and analysis (number of times the subject stops breathing during sleep, sleep stages, blood oxygen levels), and put them in a format for interpretation and action by a StartSmart physician boarded in sleep medicine or by the local physician.

3Ci’s second agreement is with Electromed Inc, Minnetonka, Minn, for its MedPulse™ respiratory vest system. The system received FDA 510(k) clearance late last year following a 5-year period of development. It is designed to assist CF and other pulmonary patients in more effective evacuation of excess mucus, which can lead to respiratory infections and life-threatening conditions.

MedPulse consists of a portable generator and vest, which together deliver a continuous series of air pulses to the chest wall. The resulting “pulse therapy” can both free and mobilize mucus in the airways of the lungs. The mobilized mucus may then be suctioned out or coughed out by the patient.

Electromed’s automated chest physical therapy (CPT) can replace traditional methods, in which a certified respiratory therapist or other trained individual manipulates the patient’s chest to dislodge mucus. Traditional treatments are costly and often unavailable for many pulmonary patients. This can lead to inadequate treatments and less favorable outcomes. Similarly, hospitalized patients may not always receive as many CPT treatments as were sought.

Electromed anticipates that many patients using the self-contained MedPulse system in the hospital will need to continue self-administered therapy at home. Consequently, it has been designed to present many user-friendly features while remaining nonintrusive.

Grass-Telefactor Selected to Produce Polysomnographic Records
Grass-Telefactor Product Group of Astro-Med Inc, West Warwick, RI, recently completed the Sleep Study Reproduction Project for the American Board of Sleep Medicine (ABSM). The specialized continuous-feed laser reproductions of actual sleep recordings were printed on four of Grass-Telefactor’s digital printers, each printing more than 16 pages per minute. More than 180,000 pages were provided for the annual ABSM examination, which was held on April 17, 2000 in Dallas. For the second and final section of the examination, candidates were required to review every page of the several hundred page record and score the printout to identify the various stages of sleep.

The ABSM has administered sleep medicine board examinations since 1991, when there were only 82 candidates. This year, the number jumped to 240. Grass-Telefactor was selected to provide the polysomnographic records for the 2000 examination after a quality inspection of more than 3,000 sample printouts it supplied to the ABSM last fall. (877) 472-7779; www.grass-telefactor.com.

Monaghan Medical Announces New VP of Sales and Marketing
Monaghan Medical Corp, Syracuse, NY, recently announced the appointment of Jon Schoeler to the position of vice president of sales and marketing, effective on April 10. Prior to joining Monaghan, he was executive officer and vice president of sales and marketing with Gliatech, Cleveland. He has also held senior positions, predominantly at the vice president level, with major medical device companies such as Johnson and Johnson, Becton Dickinson, and St Jude’s Medical.

Mitchell A. Baran, president of Monaghan Medical, says, “This important appointment reinforces Monaghan’s long-term commitment to the respiratory health care community. Jon’s 25 years of industry experience will help to ensure quality execution of the many planned new product launches in the Monaghan pipeline.” (800) 343-9071.

Respironics Awarded 2-Year Contract
Respironics Inc, Pittsburgh, recently announced that it has been awarded a 2-year contract to provide continuous positive airway pressure (CPAP) ventilation products to American Homepatient, Brentwood, Tenn. The company selected Respironics as its primary supplier for all CPAP, bi-level, and noninvasive ventilation products and accessories. In addition, Respironics was awarded dual vendor status for oximetry, infant apnea monitors, ventilators, nebulizers, and related accessories. The 2-year contract went into effect on April 1, 2000 and expires on April 1, 2002.

American Homepatient provides home health care services and products to patients through its more than 300 centers in 38 states. The company has three principal services or product lines, which include home respiratory services, home infusion services, and home medical equipment and supplies. Home respiratory services include oxygen systems, nebulizers, aerosol medications, and ventilators, and are provided primarily to patients with severe and chronic pulmonary diseases.

James W. Liken, president and CEO of Respironics, comments, “American Homepatient and Respironics have been partners for over 10 years and we are certainly excited about this opportunity to continue to work with them. This contract further solidifies our relationship with American Homepatients.” (800) 962-1266; www.respironics.com.