FDA Approves the Inspire 3028 Neurostimulator for Sleep Apnea Treatment

Inspire Medical System Inc., manufacturer of the only U.S. Food and Drug Administration (FDA)-approved implantable device for obstructive sleep apnea (OSA), has received FDA approval for its next-generation device, the Inspire 3028 implantable pulse generator, which includes magnetic resonance conditional labeling, allowing patients to undergo magnetic resonance imaging (MRI) safely.
 
“The continuous positive airway pressure (CPAP) intolerant patients I see want to lead active and engaging lives,” said Alan Kominsky, M.D., a practicing ENT-otolaryngologist at the Cleveland Clinic. “With conditional MRI labeling, the new Inspire device provides my OSA patients peace of mind now that MRIs are an option. Similar to approvals in the cardiac and neurological implantable device arenas, this labeling expansion is a welcome addition to the upper airway stimulation therapy.”
 
In addition to the conditional MRI labeling, the newly approved implantable device provides many OSA patients with a size profile that meets the needs of patients who cannot use or get benefit from CPAP. The Inspire 3028 device is 40 percent smaller and 18 percent thinner than the current Inspire neurostimulator, which received FDA approval in April 2014. 
 
“We have received consistent feedback from the medical community that providing the ability for patients to have an MRI is very important,” said Tim Herbert, president and CEO of Inspire Medical Systems. “We incorporated features to allow for an MRI and redesigned the device to have both a smaller footprint as well as being significantly thinner without compromising product functionality or device battery life which remains at about 11 years. We believe that the peace of mind and improved patient comfort with this next generation device will have a direct and positive impact on the commercial opportunity for Inspire therapy.”
 
Inspire therapy is currently being implanted in more than 100 medical centers across the United States and over 25 centers in Europe. More than 1,700 patients worldwide are currently using Inspire therapy, and objective and subjective patient outcomes have proven the therapeutic benefit of the technology.
 
Inspire also announced that two key publications have been issued in peer-reviewed medical journals further describing the safety and efficacy of Inspire therapy. First, the four-year long-term follow-up clinical data of patients in the STAR phase III pivotal trial was published last month in Otolaryngology–Head and Neck Surgery. The results of the four-year follow-up showed sustained quality of life improvements in patients who have used the therapy for over four years.
 
Also published in Otolaryngology–Head and Neck Surgery (in April) was the first multi-center trial conducted to validate the results of the STAR trial. This second trial was conducted in Germany with 60 patients implanted with the Inspire device. The authors concluded that selective upper airway stimulation is a safe and effective therapy for patients with obstructive sleep apnea and represents a powerful option for its surgical treatment.
 
“Inspire therapy is proving to be a valuable option for patients who are unable to tolerate CPAP,” said Kingman Strohl, M.D., professor of medicine at Case Western Reserve University School of Medicine and program director, Sleep Medicine at UH Cleveland Medical Center.  “I remain convinced that we will continue to see outstanding patient outcomes with the Inspire therapy system and am confident this next generation of smaller and thinner devices with conditional MRI labeling will be an important therapy for my untreated OSA patients.”
 

Inspire Upper Airway Stimulation therapy is an FDA-approved treatment for some people with moderate to severe OSA who are unable to use or get consistent benefit from continuous positive airway pressure. In contrast to CPAP, Inspire therapy is implanted inside the body and works with a patient’s natural breathing process. Controlled by the small handheld sleep remote, the system includes a breathing sensor and a stimulation lead powered by a small battery. During sleep, the system senses breathing patterns and delivers mild stimulation to the tongue and other soft tissues of the throat to keep the airway open.
 
Based in Minneapolis, Minn., Inspire Medical Systems develops OSA therapy. The company is privately held and investors include Amzak Health, Aperture Venture Partners, GDN Holdings, Johnson & Johnson, Kleiner Perkins Caufield & Byers, Medtronic plc, OrbiMed Advisors, Synergy Life Science Partners, TGap Ventures and U.S. Venture Partners.