First Subjects Implanted in ImThera Medical, Inc. Pivotal Study
THN3 study to expand the clinical evidence for this novel neurostimulation therapy for moderate to severe obstructive sleep apnea
SAN DIEGO, May 11, 2015 /PRNewswire/ -- ImThera Medical, Inc., a privately held global medical device company, today announced that the first two patients in its THN3 Clinical Study were recently implanted with the aura6000® System. The surgeries were performed by Sam Mickelson, M.D. at the Atlanta Outpatient Surgery Center in Sandy Springs, GA.
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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. THN Sleep Therapy stimulates the hypoglossal nerve increasing muscle tone of multiple tongue muscles and preventing the tongue from collapsing into the upper airway during sleep.
"The procedures were simple, fast and considerably less invasive than other sleep apnea surgeries," said Sam Mickelson, M.D., of Advanced Ear Nose & Throat Associates, Medical Director of Advanced Sleep Centers, Atlanta GA and a study investigator. "The procedures took between 60 and 90 minutes, and both patients went home less than three hours later."
The first two subjects, aged 48 and 61, suffered from obstructive sleep apnea for more than 7 and 25 years respectively and were unable to attain lasting benefit from continuous positive airway pressure or other surgical procedures.
"Too many patients are left untreated or under-treated by the currently available therapies for obstructive sleep apnea, and until now we've had very little to offer them," said Alan Schwartz, M.D. Professor of Medicine and Medical Director, Johns Hopkins Sleep Disorders Center at Bayview, Baltimore MD, and principal investigator of the THN3 study. "ImThera's device offers a unique approach to hypoglossal stimulation with its ability to selectively stimulate several muscles individually."
The THN3 Study (Targeted Hypoglossal Neurostimulation Study #3) is a FDA-approved, randomized, controlled, prospective, multi-center clinical trial. It is being conducted at leading medical centers in the United States and Europe. For more information on the THN3 Study visit www.THNStudy.com.
"This is a major milestone on our journey to make this life-changing therapy available to the millions of Americans with sleep apnea," said Marcelo Lima, President and CEO at ImThera Medical, "We look forward to the completion of the study, and the filing of a PMA application with the Food and Drug Administration."
About ImThera Medical, Inc.
San Diego-based ImThera Medical is a privately held company and a global leader in neurostimulation for the treatment of Obstructive Sleep Apnea (OSA). For more information, visit www.ImTheraMedical.com.
About OSA
OSA is characterized by repetitive episodes of respiratory arrest despite continuing breathing efforts. More than one million Americans are diagnosed annually with OSA. As many as 28 million Americans may suffer from OSA and only approximately 25 percent of this population is receiving treatment today.
While OSA is readily treated with continuous positive airway pressure therapy (CPAP), studies show that CPAP is a cumbersome treatment, and that a large number of patients cannot or will not comply with CPAP.
For more information on the THN3 Study visit www.THNStudy.com.
CAUTION: Investigational device. Limited by United States law to investigational use.
ImThera, aura6000, and THN Sleep Therapy are registered trademarks, and THN is a trademark of ImThera Medical, Inc.
© ImThera Medical, Inc. 2015. All rights reserved.
Brian Blischak (858) 259-2980 x12
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SOURCE ImThera Medical, Inc.
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