Inspire Medical Systems Inc, manufacturer of the only FDA-approved implantable device for obstructive sleep apnea (OSA), has received Food and Drug Administration (FDA) approval for its next-generation device, the Inspire 3028 implantable pulse generatorThis version includes magnetic resonance (MR) 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,” says Alan Kominsky, MD, a practicing ENT-otolaryngologist at the Cleveland Clinic, in a release. “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% smaller and 18% 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,” says 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 over 100 leading medical centers across the United States and over 25 centers in Europe. Over 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 in the journal, Otolaryngology–Head and Neck Surgery, in May 2017. 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 the April 2017 of Otolaryngology–Head and Neck Surgery, was a 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,” says Kingman Strohl, MD, 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 announced the approval of the Inspire 3028 neurostimulator at SLEEP 2017. Further, several physicians who have investigated the safety and efficacy of Inspire therapy will present their results during this meeting including the 5-year long-term clinical data from the STAR phase III pivotal as well as additional independent clinical trials and reporting on long-term compliance to the therapy.
Where is this product manufactured?