Slowly but steadily, more doctors and hospitals are offering patients a medical device made by a Maple Grove company that uses electrical stimulation to stop them from waking up dozens of times per hour.
The Mayo Clinic recently signed contracts so it can buy the sleep-apnea device from its maker, Inspire Medical Systems. A University of Minnesota otolaryngologist is now trained to implant it at Fairview Medical Center in Minneapolis and Regions Hospital in St. Paul. Hospitals in St. Cloud and Robbinsdale offer it, and another in Duluth will start soon, Inspire Chief Executive Tim Herbert said.
"It's not just a clinical study at academic centers. It is now part of commercial hospitals," Herbert said.
It's been 18 months since the FDA approved the technology, and more than five years since patients were first enrolled in clinical trials. Now Inspire faces the tough job of convincing Medicare and private insurers that the $27,000 therapy is safe and cost-effective.
Herbert said 60 insurers have preapproved patients for the Inspire Upper Airway Stimulation (UAS) device on a case-by-case basis, while they evaluate whether their own patients do as well as those in the published literature from Inspire's STAR clinical study.
The device treats moderate to severe obstructive sleep apnea, which is marked by loud and chronic snoring and sometimes choking or gasping sounds. An estimated 18 million Americans are affected.
The Inspire UAS is like a pacemaker. It consists of a pulse generator implanted under the skin near the shoulder, plus two wires — one that senses breathing activity during sleep, and another that delivers mild electrical stimulation to the tongue and throat to keep the airway open. It is controlled by a patient sleep remote.
Another commonly used therapy for sleep apnea, called Continuous Positive Airway Pressure, or CPAP, is about 10 times cheaper than the Inspire UAS.
Herbert said Inspire's device is intended for patients who can't tolerate a CPAP, which has a breathing mask that is worn while sleeping. He noted that the roughly $27,000 price tag for the Inspire UAS includes the device and the medical procedure, and is typically covered by insurance. He said the 10-year cost of a CPAP runs at least $8,000.