Intersect ENT has received a nod from FDA for a new delivery system to use for its sinus implant. The Menlo Park, CA-based company said the approval was for its Straight Delivery System for use to place the Propel Mini steroid releasing sinus implant in the ethmoid sinus.
PROPEL Mini helps maintain the sinus opening while delivering mometasone furoate directly where it is needed, improving outcomes of frontal (behind the forehead) and ethmoid (behind the bridge of the nose) sinus surgery. The new SDS is designed to help physicians achieve precise and easy delivery of the PROPEL Mini implant to the ethmoid sinus. The company said the original curved delivery system will continue to be packaged with the Propel Mini sinus implant and used for implant delivery to the frontal and ethmoid sinuses.
“We listened to feedback from physicians offering PROPEL Mini to their patients, and we are pleased to deliver this new delivery system, developed specifically with ease of use and overall procedure time in mind,” Tom West, president and CEO of Intersect ENT, said in a release. “The Straight Delivery System provides physicians with another opportunity to customize treatment to achieve the best possible patient results.”
The approval comes on the heels of Intersect ENT’s long-time CEO Lisa Earnhardt stepping down for a position of Head of Devices at Abbott Laboratories.