A Minnesota company wins the race to get FDA approval for the first implantable neurostimulation treatment for obstructive sleep apnea.
|The Inspire Upper Airway Stimulation System|
At one point of time, there were at least three companies in the U.S. aiming to win FDA approval to launch an implantable neurostimulator to treat obstructive sleep apnea.
Then there were just two.
Now, Maple Grove, Minnesota-based Inspire Medical has edged out the others in winning approval for the first implantable device to treat the sleep disorder. An in-state competitor Apnex Medical shut down in 2013 after it deemed that it would be unable to meet its primary endpoint in a clinical trial. The third company in the space - San Diego-based ImThera Medical - announced in September that it has completed enrollment in a pivotal trial to test its version of a device that uses mild electric pulses to control the symptoms of OSA.
The Inspire Upper Airway Stimulation (UAS) therapy can be used in patients with moderate to severe Obstructive Sleep Apnea (OSA) who are unable to use Continuous Positive Airway Pressure (CPAP), widely considered the gold standard in treating patients with the chronic condition. It will be available commercially in the second half of the year.
There are several kinds of sleep apnea, which affects more than 18 million Americans, according to the National Sleep Foundation. In obstructive sleep apnea, breathing starts and stops repeatedly during sleep because the muscles of the throat fail to keep the airway open even though person who is asleep is trying to breathe. In the pivotal trial, patients implanted with Inspire therapy saw a 68% reduction in apnea events, a 70 percent reduction in oxygen desaturation events, and signiﬁcant improvements in daytime functioning as measured by two validated questionnaires, according to the company. Results were published in the New England Journal of Medicine.
The Inspire system comprises three components -a small generator, a sensing lead and a stimulation lead - to sense breathing patterns and deliver mild electrical pulses to keep the key airway muscles open during sleep. An external handheld device serves as a remote control to turn the therapy on before bed and off upon waking.
"This therapy represents a major advance in sleep apnea treatment for some patients who are unable to use or tolerate CPAP therapy,” said Dr. Meir Kryger, professor, Yale School of Medicine, in a news release announcing the approval Thursday. “Patients with moderate to severe OSA who are not on effective treatment are at an increased risk for cardiovascular disease, accidents and death. There is a signiﬁcant need for safe, effective and well-tolerated new treatments in the sleep medicine ﬁeld.”
In comparison to the Inspire device, the rival aura6000™ System from ImThera Medical has two implantable components instead of three: a chargeable pulse generator placed under the skin near the collarbone, and a multi-electrode lead placed in the upper neck.
[Image Credit: Inspire Medical Website]