Intersect ENT has secured approval from the US Food and Drug Administration (FDA) for its Propel Contour steroid releasing sinus implant.
Featuring an advanced hourglass design, the implant will help to treat patients with chronic sinusitis in the frontal (behind the forehead) and maxillary (behind the cheeks) sinuses.
The approval allows the firm to use Propel family of steroid releasing implants for the treatment of patients undergoing ethmoid, frontal or maxillary surgeries.
Intersect ENT’s new Propel family product has been developed to adjust to the sinus ostia (openings), helping to focus on drug delivery and mechanical support where it is required.
The implant includes a low-profile flexible delivery system to access tight areas of the sinus anatomy.
The approval was based on the positive data of the Propel Contour cohort of the Progress study, which assessed the safety and efficacy of the implant when placed in the frontal sinuses following surgery.
Propel products, which are claimed to be the first and only FDA-approved dissolvable steroid releasing sinus implants, will mechanically prop open the sinuses and release mometasone furoate.
Mometasone furoate is an advanced corticosteroid with anti-inflammatory properties, directly into the sinus lining then dissolve.
Intersect ENT president and CEO Lisa Earnhardt said: “The approval of PROPEL Contour adds a third product under the PROPEL umbrella, expanding our offering of steroid releasing implants to improve surgical outcomes.
“With its strong clinical evidence, we expect that Propel Contour will extend adoption of our sinus implants both in the operating room as well as in the office, and that offering physicians a wide range of products to customize treatment based on their patients’ disease and anatomy will ultimately lead to broader overall usage.”
Image: Intersect ENT's Propel Contour steroid releasing sinus implant. Photo: courtesy of Business Wire.