August 30th, 2013 Renowned Hudson Valley ENT Sleep Specialist Selected to Participate in FDA Study of New Obstructive Sleep Apnea Treatment
Renowned Hudson Valley ENT Sleep Specialist Selected to Participate in FDA Study of New Obstructive Sleep Apnea Treatment
Middletown, NY (PRWEB) June 24, 2013
Ofer Jacobowitz, M.D., PhD. FAASM, FAAOA, an Otolaryngologist and Sleep Medicine specialist, is one of only three doctors in the United States who have been selected by the sponsor to participate in the current FDA study for ImThera Medical’s aura6000tm, a neurostimulation device for treating Obstructive Sleep Apnea (OSA). Dr. Jacobowitz, a nationally and internationally recognized expert in sleep apnea, has implanted the device in five patients to date. The procedures were performed at Orange Regional Medical Center (ORMC) located in Middletown, NY, where Dr. Jacobowitz serves as Associate Medical Director of the ORMC Center for Sleep. Dr. Jacobowitz is the only physician conducting the study in New York State and the study is the only one taking place on the East Coast.
The aura6000 device delivers electrical pulses to generate targeted motions of the tongue in order to keep patients’ airways open during sleep. The device is implanted in a surgical procedure that averages approximately 60 minutes. The system uses ImThera Medical’s patented Targeted Hypoglossal Neurostimulation (THN™ Sleep Therapy) to focus neurostimulation on certain muscles of the tongue, and acts as a “pacemaker” preventing the tongue from blocking the airways during sleep, the primary cause of obstruction in a majority of sleep apnea patients. The aura6000 is one of the world’s smallest implantable rechargeable stimulators and does not require external sensors to function. Prior to sleep, patients simply turn it on with the push of a button on a remote controller.
ImThera Medical, Inc. announced European CE Mark (Conformité Européenne) approval of its aura6000 system in March 2012. The device is investigational in the US.
“I am extremely honored to have been selected to conduct the FDA trials,” said Dr. Jacobowitz. “Many sleep apnea patients will not wear cumbersome air pressure devices to get a good, healthy and safe night’s sleep and others will not even seek treatment for the same reason. New innovations offer hope to those patients for whom the appropriate treatment for their condition may seem as onerous as the condition itself. I look forward to the results from my patients and those of my esteemed colleagues.” In addition to Dr. Jacobowitz’s study in New York, additional study sites are in Chicago and Denver in the United States, and in Europe in Brussels and several cities in Germany.
Dr. Jacobowitz is a member of the sleep disorders and the medical drugs and devices committees at the American Academy of Otolaryngology/Head and Neck Surgery and is a founding member of the International Surgical Sleep Society. He serves on the clinical outcomes task force of the American Academy of Sleep Medicine and has served as Chair of the sleep-related breathing disorders section and all membership sections from 2012 to 2013. He is also an assistant Professor of Otorhinolaryngology Head and Neck Surgery at the Mount Sinai Hospital in NY, Columbia/New York Presbyterian Hospital in NY and a practicing partner at Hudson Valley ENT in Middletown, New York.
More than 800,000 patients in the U.S. are diagnosed with OSA annually. The industry estimates that as many as 38 million Americans may suffer from OSA and that approximately only 20 percent of the population is getting treatment today. Left untreated, OSA may lead to many serious consequences, including: hypertension, congestive heart failure, atrial fibrillation, stroke, type II diabetes, weight gain, depression and traffic accidents.
About ImThera Medical, Inc and THN Sleep Therapy
ImThera Medical has developed a novel neurostimulation system for the treatment of OSA. The aura6000 system delivers the THN Sleep Therapy via a multi-contact electrode array that can selectively stimulate different portions of the hypoglossal nerve to increase muscle tone in key tongue muscles during sleep, thereby opening the upper airway. In addition, the aura6000 neurostimulator cycles stimulation between several tongue muscles to prevent fatiguing any single muscle.
ImThera’s mission is to provide a safe and effective alternative for OSA patients who cannot comply with CPAP so that they can live longer and enjoy better lives, while substantially reducing health care costs related to the serious complications associated with untreated obstructive sleep apnea.
CAUTION: The aura6000 is an investigational device, limited by United States law to investigational use.
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