Inspire Medical Systems Announces FDA Approval of New Sensing Lead

Inspire Medical Systems (NYSE:INSP) a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea, announced today that the U.S. Food and Drug Administration has approved for use in the U.S. Inspire’s new sensing lead.  Inspire intends to introduce the new sensing lead to its U.S. medical center customers in March 2019.

As quoted in the press release:

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 Chief Executive Officer 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.”

Click here to read the full press release.