The US Food and Drug Administration (FDA) has approved for use in the United States Inspire Medical Systems Inc’s new sensing lead. Inspire intends to introduce the new sensing lead to its US medical center customers in March 2019.
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%, 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 ear-nose-throat surgeon.
“We are pleased to receive FDA approval of the new sensing lead for Inspire therapy,” says Tim Herbert, president and CEO of Inspire Medical Systems, in a release. “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.”
