×

ENT and Allergy Associates(R) Announce ImThera Medical Clinical Study

TARRYTOWN, N.Y., May 28, 2015 (GLOBE NEWSWIRE) -- The following is a message from Dr. Ofer Jacobowitz, partner of ENT and Allergy Associates:

Sleep apnea is a serious and dangerous disease where the airway obstructs numerous times during sleep. This can lead to heart attacks, strokes, diabetes, daytime sleepiness, car accidents, mood problems and low productivity.

Treatments for sleep apnea are readily available but the most common form of treatment, CPAP, which pressurizes the airway with air, is often rejected or poorly tolerated in the long term. Many patients do not tolerate or accept wearing a mask of their face during sleep or an appliance in their mouth. Others are reluctant to undergo reconstructive surgery of the throat.

Now there is a new investigational treatment for sleep apnea. Dr. Ofer Jacobowitz is now enrolling volunteers in the U.S. Food and Drug Administration (FDA) approved THN3 (Targeted Hypoglossal Neurostimulation pivotal 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.

When we sleep, we lose muscle tone and this is why the airway closes during sleep in sleep apnea patients. Dr Jacobowitz surgically implants a tiny neurostimulator under the skin of the upper chest and connects it to the nerve that activates muscle tone in the tongue. With a push of a button on a remote controller, the patient can now activate tone in the tongue during sleep, and sleep "soundly", without the frequent awakenings that occur with sleep apnea. It's a form of muscle training, and there is preliminary data that it may make the tongue more fit over time.

When we turned the device off after a year, the next night with the device off we did not see sleep apnea return.

Dr. Jacobowitz is the only physician in NY conducting the study and has implanted the largest number of implants in the US with ImThera Medical's (San Diego, CA) device in the preceding trial. He is a nationally and internationally recognized expert in the treatment of obstructive sleep apnea. He is a partner with ENT and Allergy Associates in NY and assistant professor at Mount Sinai hospital.

Dr. Jacobowitz would be happy to discuss this further with you, so your readers who suffer with Sleep Apnea can be a part of this ground breaking clinical study.

I appreciate your time and consideration, if you're interested in learning more, please email Jason Campbell at JCampbell@entandallergy.com or call at 914-984-2531. Or contact our Clinical Research team at, ClinicalResearch@entandallergy.com, direct line 845-562-5941.

CONTACT: Keith Arluna 560 White Plains Rd Suite 615 Tarrytown, NY 10591 karluna@entandallergy.com 914-575-1934

Source: Ent and Allergy