Devices & Diagnostics

Inspire Medical gets regulator OKs for sleep apnea therapy

Medtronic Inc. spinout Inspire Medical Systems Inc. has received the go-ahead from regulators to sell its obstructive sleep apnea device in Europe and test it for the U.S. market.

Medtronic Inc. spinout Inspire Medical Systems Inc. has received the go-ahead from regulators to sell its obstructive sleep apnea device in Europe and test it for the U.S. market.

CE Marking in hand, the Maple Grove, Minnesota, device developer expects to mount a market development push for its Inspire Upper Airway Stimulation therapy in Europe near year-end 2011.

The company also has received a Food and Drug Administration nod to begin testing the device for safety and efficacy among patients with moderate or severe obstructive sleep apnea at several medical centers in the United States and Europe. U.S. patients enrolled in its STAR (Stimulation Therapy for Apnea Reduction) pivotal trial are expected to begin being implanted early next year.

Results of the pivotal trial likely will form the base for U.S. market approval of the device that delivers a gentle electrical pulse during sleep to restore tone to the muscles that hold the tongue in place. More than 15 million adults in the United States alone are believed to suffer from obstructive sleep apnea (OSA), a condition in which the airway relaxes too much during sleep, cutting off breathing.

Apnea can do more than steal sleep. “Patients with untreated sleep apnea are at higher risk of developing hypertension, heart failure and stroke,” said Dr. Meir Kryger, director of Sleep Medicine Research and Education at Gaylord Hospital in New Haven, Connecticut, in an Inspire Medical statement.

But several therapies for OSA, including continuous positive airway pressure (CPAP) systems, can significantly affect the lifestyles and comfort of patients and their bed partners, said Tim Herbert, Inspire Medical’s president and CEO, in his company’s statement.

“As a result, patient compliance for these front-line therapies is sub-optimal,” Herbert said. “A substantial number of patients suffering from OSA are looking for a new approach to treat this challenging condition.”

Inspire Medical’s therapeutic device and implant procedure may be one of those new approaches.

“Inspire’s stimulation therapy is well-suited to address the root cause of OSA for many patients, which is a decrease in airway muscle tone during sleep,” said Professor Paul Van de Heyning, director of Otolaryngology and Head and Neck Surgery at the University of Antwerp in Antwerp, Belgium, who recently implanted the first patient in the STAR trial.

“The Inspire implant procedure is less invasive than most OSA surgical techniques, which will likely contribute to faster patient recovery times,” Van de Heyning said in Inspire’s statement. “The STAR trial will provide valuable information on the potential role of upper airway stimulation therapy.”

Minnesota has become a bit of a hub for startups looking to correct breathing-related sleeping problems. Cardiac Concepts Inc. in Minnetonka recently raised $27.2 million for its pacemaker-like device that uses electricity to treat sleeping disorders. And Apnex Inc. in St. Paul is developing an implantable device that uses electricity to open airways closed by obstructive sleep apnea.

Inspire Medical last raised money in 2009 — a $17 million B Round led by Synergy Life Science Partners that included existing investors Kleiner Perkins Caufield & Byers, U.S. Venture Partners, Medtronic (NYSE:MDT) and Dr. Glen D. Nelson through GDN Holdings.

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