Minnesota-based Inspire Medical Systems has a date with the FDA tomorrow, when the agency’s expert Anesthesiology & Respiratory Therapy Devices Panel will review data and make a recommendation on the Inspire II Upper Airway Stimulator.
Inspire Medical was spun out of medtech titan Medtronic (NYSE:MDT) in 2007, taking with it therapy concepts stemming from trials begun in 1998. The company’s Inspire II device is a permanent implant designed to stimulate nerves to keep the airways open during sleep. The implant delivers mild electrical stimulation to the hypoglossal nerve, preventing the tongue from obstructing breathing.
Inspire Medical won CE Mark approval in 2010 to market the device in the European Union.
In materials released ahead of tomorrow’s panel review, FDA regulators highlighted concerns with non-serious adverse events associated with long-term use of the implant and asked its advisors to consider the durability of the therapy, proper screening methods, post-approval study protocols and other aspects of the technology and its potential entry to the U.S. market.
In a draft of questions for the panel, the FDA asks reviewers to dig into the adverse events seen during Inspire’s clinical trials, including cases of tongue soreness, irritation and abrasion, mouth dryness, mechanical pain and discomfort associated with electrical stimulation. Some of the adverse events remained unresolved by the end of the trial, regulators noted. Inspire had recommended a 12-month follow-up study to watch for specific adverse events, but the FDA’s review team is leaning toward 5 years since the device is a permanent implant and adverse events seen in trials were long-lasting, the agency said.
The FDA further asked the panel to consider that some patients in the clinical trials underwent several titrations or fine-tuning of their stimulators to address discomfort. Given the need for multiple titrations, the FDA asked reviewers to consider whether the trial had a meaningful thread of time to demonstrate durability in treatment and how best to address potential tuning needs in the device’s label.
Tomorrow’s panel will also address patient screening methods to determine which are best candidates for the therapy as well as trial parameters and protocols for post-approval studies. The reviewers will meet tomorrow from 8 a.m. to 6 p.m.