FDA
4th March 2014

FDA Device Panel Votes Favorably for First-in-Class Treatment of Obstructive Sleep Apnea

The U.S. Food and Drug Administration’s (FDA’s) Anesthesiology & Respiratory Therapy Devices Panel recommended Inspire Medical’s.

FDA Device Panel Votes Favorably for First-in-Class Treatment of Obstructive Sleep Apnea

The U.S. Food and Drug Administration’s (FDA’s) Anesthesiology & Respiratory Therapy Devices Panel recommended Inspire Medical’s (Maple Grove, MN) Inspire II Upper Airway Stimulator (UAS) for approval for the treatment of moderate to severe obstructive sleep apnea (OSA) at last week’s panel meeting. Innovative Science Solutions (ISS) assisted Inspire Medical in the preparation of this panel meeting, providing our state-of-the art project management and slide management system – DataTrove®, as well as participating in the mock rehearsals leading up to the meeting. ISS looks forward to learning of FDA’s final decision for this unique treatment option.

The panel voted unanimously in favor (with 1 abstention) for each question regarding the device’s safety, efficacy and benefit risk profile. In the briefing materials released prior to the panel meeting, FDA’s reviewers highlighted concerns with non-serious adverse events such as tongue soreness, irritation and abrasion, mouth dryness, mechanical pain and discomfort associated with electrical stimulation. The advisors further examined the durability of the therapy, proper screening methods, and post-approval study protocols.

Inspire II’s primary study results stemmed from a multicenter, prospective trial – STAR (Stimulation Therapy for Apnea Reduction), and were published in the New England Journal of Medicine in January of this year. In response to the treatment, two thirds of patients experienced a clinically significant reduction in sleep apnea episodes as well as a reduction in daytime sleepiness, and improvement in quality of life.

The Inspire II UAS utilizes electrical stimulation of the hypoglossal nerve to keep airways open during sleep, specifically preventing the tongue from collapsing and obstructing the patient’s breathing. During implantation, a stimulation electrode is placed on the hypoglossal nerve, a sensing lead is placed between intercostal muscles to sense breathing patterns, and a neurostimulator is implanted below the clavicle. Patients turn the device on at night using an external controller. In a marked contrast to other surgical procedures available to treat obstructive sleep apnea, the Inspire therapy does not require alteration of the patient’s anatomy. Other existing therapies for OSA include oral devices and continuous positive airway pressure (CPAP).

CPAP is a non-invasive medical device consisting of a mask placed over a patient’s nose and mouth during sleep. While CPAP can be very effective in patients when used, it has been found to have a poor rate of compliance. CPAP failure or CPAP intolerance is a predicate for treatment with the Inspire II UAS, effectively making Inspire a second-line treatment. OSA affects approximately 12 million people in the U.S. alone. Repeated episodes of apnea due to airway collapse can lead to daytime fatigue leading to a decreased quality of life and increased risk for work-place and motor vehicle accidents. OSA also increases a person’s risk for more severe complications, typically cardiovascular in nature.

Currently, the Inspire Therapy is CE Marked and approved for sale in Europe. While FDA is not bound by the panel’s decision, they normally follow their recommendation.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

Interested in learning about ISS’ expert approach to Advisory Committee Meetings? Click below in order to find out for yourself!

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