Intersect ENT Announces Publication of PROGRESS Study for PROPEL mini in Patients With Frontal Sinus Disease
Posted on July 12, 2016 by Medtech[y] Staff
Intersect ENT announced the publication of results of the PROPEL® mini cohort of the PROGRESS study in The Laryngoscope. PROGRESS is a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of the PROPEL® mini steroid releasing sinus stent when used following frontal sinus surgery.
Intersect ENT's PROPEL® is a dissolvable implant for chronic sinusitis patients undergoing sinus surgery; the first and only sinus surgery product backed by Level 1-A evidence. The implant is inserted by a physician to maintain the surgical opening and the spring-like implant expands to prop open the ethmoid sinus, gradually delivering an advanced corticosteroid (mometasone furoate) with anti-inflammatory properties directly to the sinus lining as the implant dissolves.
More than 100,000 U.S. patients have been treated with PROPEL and PROPEL mini.
How PROPEL® Works
PROPEL® mini, a smaller version of PROPEL®, offers the same drug dose and clinical benefits. In March 2016 Intersect ENT received approval for an expanded indication from the U.S. Food and Drug Administration (FDA) for placement of PROPEL mini in the frontal sinuses, which are located behind the eyebrows.
As previously reported, the study met its primary efficacy endpoint, demonstrating a statistically significant 38% relative reduction in the need for post-operative interventions (p=0.007) at 30 days compared to surgery alone with standard post-operative care. Post-operative interventions included the need for additional surgical procedures and/or need for oral steroids. Clinical investigators also reported a 54% relative reduction in restenosis, a 56% relative reduction in the need for oral steroids, and a 75% relative reduction in the need for surgical interventions on sides treated with PROPEL mini compared to surgery alone at 30 days. The device placement success rate was 100% and there were no device-related adverse events.
“The results from the PROGRESS study are important because they demonstrate that PROPEL mini improves the outcomes of frontal sinus surgery when added to standard postoperative care in chronic sinusitis patients with frontal sinus disease undergoing sinus surgery,” said Randall Ow, M.D. of Sacramento Ear, Nose, and Throat, a lead enroller in the study. “The recent expanded indication for PROPEL mini was much anticipated because the frontal sinus is more difficult to operate on and to manage post-operatively, compared to the other sinuses.”
“The positive outcomes from PROGRESS add to the growing clinical evidence demonstrating the benefits of steroid releasing implants,” said Lisa Earnhardt, president and CEO, Intersect ENT. “Frontal sinusitis affects as many as one in four patients undergoing surgery for chronic sinusitis. We are excited that this patient population now has access to treatment with PROPEL mini.”
The original press release