Inspire Medical Systems Inc., a medical technology company focused on the development and commercialization of minimally invasive solutions for patients with obstructive sleep apnea, has received U.S. Food and Drug Administration (FDA) approval of its new sensing lead. Inspire is introducing the new sensing lead to its U.S. medical center customers this month.  
 
The sensing lead monitors a patient’s respiratory pattern as the implanted Inspire system delivers stimulation to the upper airway in order to prevent obstructions during sleep. The new sensing lead has a significantly smaller profile, including a reduction in diameter of 49 percent, as compared to the prior design. This smaller profile is intended to improve the patient’s comfort. The new design also incorporates several features to enable easier implanting and potentially reduce surgical time for an ENT surgeon.
 
“We are pleased to receive FDA approval of the new sensing lead for Inspire therapy,” said Tim Herbert, president and CEO of Inspire Medical Systems. “The improved features of the sensing lead have led to more reliable and simpler implant procedures, as demonstrated by our recent European experience with the new sensing lead since its introduction in Europe in October 2018. We believe that the product enhancements with this next generation sensing lead will continue to have a positive impact on the commercial opportunity for Inspire therapy.”
 
Inspire is a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.