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05/28/2015 in press release
ENT and Allergy Associates’ Renowned OSA expert Dr. Ofer Jacobowitz
Now enrolling volunteers in FDA Study of Neurostimulation for Obstructive Sleep Apnea
Tarrytown, NY –ENT and Allergy Associates® (ENTA) and ImThera Medical, Inc. announced that Dr. Ofer Jacobowitz is now enrolling volunteers in the U.S. Food and Drug Administration (FDA) approved THN3 (Targeted Hypoglossal Neurostimulation Study #3) Clinical Study. The THN3 Study is evaluating the safety and effectiveness of the aura6000® implantable neurostimulation system for moderate to severe obstructive sleep apnea (OSA) in individuals who are unable to comply or unwilling to try PAP therapy or other OSA treatments. The Study randomized, controlled, prospective clinical trial is being conducted at ENTA and other leading medical centers in the United States and Europe. ENTA’s nationally and internationally renowned Sleep Expert Ofer Jacobowitz, MD, PhD, FAASM is honored to serve as Principal Investigator at ENTA in this important and exciting study.
The aura6000 system is based on ImThera’s proprietary THN Sleep Therapy® technology. The system consists of two implantable components, a small rechargeable pulse generator placed under the skin near the collarbone, and a multi-electrode lead placed in the upper neck. The electrodes deliver mild pulses to the hypoglossal nerve, stimulating various muscles and thereby increasing muscle tone of multiple tongue muscles and preventing the tongue from collapsing into the upper airway during sleep. This innovative technology is designed to address nighttime upper airway blockage, permitting normal and restful sleep for OSA patients.
“Neurostimulation therapy is an ingenious approach to obstructive sleep apnea, a common disease that is difficult to treat” said Dr. Jacobowitz. “The treatment targets the core issue of sleep apnea—loss of muscle tone in sleep. I am excited to bringing this pivotal Study to New York City.”
For more information about the study and to see if you may qualify, visit www.THNStudy.com, or call Suzanne at 845-562-5941.
About Dr. Jacobowitz
Dr. Ofer Jacobowitz MD PhD FAASM is globally recognized as a preeminent expert in the treatment of OSA. He has served as an Expert Member of the Outcome Measures Task Force for Adult OSA of the American Academy of Sleep Medicine and as Chair of the sleep-related breathing disorders section and all membership sections from 2012 to 2013. Dr. Jacobowitz is the recipient of the honor award of the American Academy of Otolaryngology Head and Neck Surgery where he is also a member of the Sleep Disorders and the Medical Devices Committees. Dr. Jacobowitz serves as Assistant Director of Night and Day Sleep Services, a clinical subdivision of ENT & Allergy Associates that provides comprehensive sleep examinations at all its eight labs in New York and New Jersey in relaxing and private bedroom-style settings equipped with hotel style amenities.