PROPEL Contour steroid releasing implant approved by FDA

Chronic sinusitis, or chronic rhinosinusitis, is an ordinary condition that causes the inflammation and swelling of cavities around the nasal passages. It can persist for up to 12 weeks in spite of treatment attempts. Recently, Intersect ENT, a California-based company, has earned clearance from the FDA for its Propel Contour steroid-releasing sinus implant. The implant is developed for treating the chronic sinusitis in the maxillary, that is, behind the cheeks, and frontal, that is, behind the forehead, sinuses.

PROPEL Contour is the newest member to the PROPEL umbrella of steroid liberating sinus implants, which is developed specifically to fit the sinus ostia, concentrating on mechanical support and drug delivery where it is required so as to maximize sinus surgery endpoints. The implant presents a low-profile supple delivery system for making the access to tight regions of the sinus anatomy simpler.

By gaining the approval, PROPEL Contour will be permitted for treating patients undergoing frontal, maxillary, or ethmoid surgeries that embody the majority of processes for the of chronic sinusitis treatment.

Intersect ENT’s President and CEO, Lisa Earnhardt, said, “PROPEL Contour’s approval by FDA makes the addition of a third device within the PROPEL family, increasing our contribution of steroid-releasing implants to advance surgical results. With its relevant clinical verification, we look forward to that PROPEL Contour will expand implementation of our sinus implants in the offices and the operating rooms. And further providing physicians with a broad array of products to tailor treatment on the basis of their patients’ anatomy and disease will eventually lead to wider overall use.”

Satisfying data from the PROGRESS trial, which is a randomized, prospective, multicenter, blinded study consisting of 80 patients evaluating the efficacy and safety of the PROPEL Contour steroid-releasing implant when rested in the frontal sinuses after surgery encouraged its approval. The study successfully accomplished its primary efficiency endpoint, representing a statistically considerable 65% relative decrease in the requirement for postoperative medications, including the need for add-on surgical process or the requirement of oral steroid prescription, in comparison to surgery alone.

So, now people with chronic sinusitis can heave a sigh of relief. Isn’t it?

Vaibhav Bhosale undertook the post of Content Writer at Medical Device News in November 2016, following a 1.2-year of experience as an Project Lead; Instructional Writer at eNyota Learning Pvt. Ltd. His immense interest in reading brought him in this field.

He can be reached at vaibhav@medicaldevicenews.net