U.S. Approves First-of-Its-Kind Implant for Sleep Apnea
U.S. regulators have approved a first-of-its-kind implant that can help ward off moderate to severe sleep apnea, a chronic disorder that affects up to 18 million Americans.
Sleep apnea is a condition in which the breathing passage collapses or becomes blocked during sleep. Complications can include heart disease and increased risk of accidents and death.
The Inspire Upper Airway Stimulation therapy, which has been given the green light by the U.S. Food and Drug Administration, is designed for patients unable to benefit from available therapies.
The device contains a small neurostimulation generator that is surgically implanted in the chest, along with a lead that stimulates a nerve that runs from the ear to the jaw, and another sensing lead that goes to the chest.
Once implanted, the device can be activated before bedtime with a remote control.
The product is expected to be available to consumers later this year, but a spokeswoman for the Minnesota-based Inspire Medical Systems said a price has not been determined.
Research published earlier this year in the New England Journal of Medicine found that it led to a 68 percent reduction in apnea events and significant improvements in daytime function.
“This therapy represents a major advance in sleep apnea treatment for some patients,” said Meir Kryger, professor at the Yale School of Medicine.
“There is a significant need for safe, effective, and well-tolerated new treatments in the sleep medicine field.”