Intersect Ent PMA Approved for Sinus Implant Delivery

FDA has approved an Intersect Ent PMA for its Straight Delivery System for use in placing the company’s Propel Mini steroid-releasing implant in the ethmoid sinus. The company says Propel is intended to help 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 device is intended for use in patients 18 years of age and older following ethmoid/frontal sinus surgery to maintain patency of the ethmoid sinus or frontal sinus opening, the company says. It “separates/dilates surrounding mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces inflammation,” it says. Additionally, it reduces the need for post-operative intervention such as surgical adhesion lysis or use of oral steroids.