The body of published data supporting Inspire therapy grew this past week, with the publication of two papers. The first paper, published online in Otolaryngology–Head and Neck Surgery, finds that withholding Inspire therapy causes a worsening of both objective and subjective measures of sleep-disordered breathing, leading the paper’s authors to directly attribute the reduction in obstructive sleep apnea (OSA) severity and improvement of quality of life for patients to Inspire therapy.
Inspire therapy is an FDA-approved treatment for a subset of people with moderate to severe OSA who are unable to use CPAP and meet the patient selection criteria. The fully implanted system delivers mild stimulation to keep a patient’s airway open during sleep and does not require a mask.
The researchers conducted a randomized controlled therapy withdrawal study to assess the efficacy and durability of upper airway stimulation to treat OSA. Participants were randomized to either a therapy maintenance (”ON”) group or a therapy withdrawal (”OFF”) group. Short-term withdrawal effect as well as therapy durability at 18 months were assessed.
Both groups demonstrated significant improvements at 12 months compared to study baseline. In the randomized assessment, the therapy withdrawal group experienced a return of their OSA, while the therapy maintenance group remained effectively treated. At 18 months with Inspire therapy ON in all patients, both groups showed sustained improvements similar to 12 months.
In addition, a second paper published online by the European Respiratory Journal reports on research to define the mechanism of how Inspire therapy works to relieve systems of OSA. The research demonstrated that Inspire therapy increases the airway at multiple levels including near the back of the tongue as well as at the level of the soft palate.
The researchers of the two papers presented their findings at the 75th annual scientific meeting of the American Academy of Otolaryngology (AAO), taking place September 19-23 in Orlando, Fla.
“Upper Airway Stimulation for obstructive sleep apnea has been researched for over 20 years,” reports Dr B. Tucker Woodson from the Medical College of Wisconsin in Milwaukee, in a release. “The therapy is approved in the United States, and there is strong evidence to support the use of the therapy in select patients who are unable to use CPAP.”
“OSA is a prevalent disorder affecting millions of adults in the United States and our Inspire therapy technology is helping to fill a tremendous unmet need for innovative, easy to use therapies. This growing body of data supports the use of Inspire therapy for patients who are unable to find relief from front line treatments for OSA such as CPAP,” says Tim Herbert, Inspire Medical Systems president and CEO. “Since receiving FDA approval in April, there has been strong interest from both patients and physicians. Inspire therapy is now available at leading medical centers in the United States and Europe.”