FDA label update eases access to Inspire's sleep apnea implant

Inspire Medical Systems has won an expanded label from the FDA for its eponymous medical device for obstructive sleep apnea (OSA) that should expand the number of people it can be used to treat.

OSA is a common condition that causes interruptions in breathing during sleep, which can have serious health consequences including an elevated risk of high blood pressure, heart attack, stroke and diabetes. It is estimated to affect around 20 million adults in the United States alone, many of whom are undiagnosed.

The Inspire nerve-stimulating implant provides mild stimulation to a nerve in a patient's jaw during sleep, helping to keep part of the upper airway open by moving the tongue forward, and is turned off and on by the patient using a remote.

Like a pacemaker, the device is implanted in the chest\ and is seen as an alternative to the more common—and bulky—continuous positive airway pressure therapy or CPAP machines, which require a mask to be worn at night.

The device was first approved by the FDA in 2014 as a second-line therapy for moderate to severe OSA who have not been able to manage the condition with weight loss, positional therapy, or CPAP devices.

Their label included some other restrictions, namely that patients must not have complete blockage of the airway, could not be treated with a tonsillectomy or other corrective soft tissue surgery, were unable to tolerate CPAP therapy and were not highly obese. It was also cleared for use in patients with an average of no more than 65 apnea and hypopnea episodes that occur per hour of sleep, a measure known as the Apnea Hypopnea Index (AHI).

Now, that maximum AHI has been raised to 100 episodes, a level that places patients at the upper end of the severe category. At the same time, the label changes the wording of a warning label for the device, which formerly said that it had not been tested in people with a BMI greater than 32, raising that to a BMI of 40.

Inspire CEO Tim Herbert said in a June 9 press release that changes have come on the back of a registry study called ADHERE that “demonstrated that Inspire is a safe and effective treatment for [these patients] who experience severe OSA and have historically had limited treatment options available.”

While Inspire remains the only FDA-approved implantable device for OSA it does have some rivals in the market, such as Signifier Medical Technologies’ eXciteOSA, which also uses electrical muscle stimulation to treat the condition.

In this case, however, the removable device is used while the patient is awake to improve the muscle function of the tongue, helping to prevent it from collapsing backward and obstructing the airway during sleep. eXciteOSA was approved by the FDA in 2021.

Inspire meanwhile is still working on refinements to the implant, including adding in software that would record sleep apnea patterns and transfer the data via Bluetooth for review by a clinician.