The Propel Sinus Implant from Intersect ENT has received FDA Premarket approval. The product is a bioabsorbable implant that keeps areas within and around the sinuses patent after sinus surgery. A physician inserts the implant after functional endoscopic sinus surgery via a delivery system to the ethmoid sinus (sinus located between the nose and eyes). The self-retaining and self-expanding implant is made of a bioabsorbable copolymer that is absorbed by the body over the course of 4 to 6 weeks. A steroid, mometasone furoate, within the device decreases local inflammation while implanted.
The Propel Sinus implant is intended for adults who undergo ethmoid sinus surgery to help reduce the need for post-operative oral steroids and/or additional surgical procedures due to scar tissue formation. Results of a randomized, double-blind, multi-center study (ADVANCE II) will be presented at the annual American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) conference in September.
Image: 1) polyps obstructing the ethmoid sinus before surgery 2) stent delivery system in the ethmoid cavity 3) stent placed in the cavity.
Product page: Propel …