Steroid releasing implant receives FDA approval

27th February 2017
Posted By : Enaie Azambuja
Steroid releasing implant receives FDA approval

Intersect ENT announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for its PROPEL Contour steroid releasing sinus implant. PROPEL Contour features an innovative hourglass design that facilitates treatment of patients with chronic sinusitis in the frontal (behind the forehead) and maxillary (behind the cheeks) sinuses.

With this approval, Intersect ENT’s PROPEL family of steroid releasing implants allows for treatment of patients undergoing ethmoid, frontal or maxillary surgeries, which represent the majority of procedures for the treatment of chronic sinusitis.

PROPEL Contour, the latest in the PROPEL family of steroid releasing sinus implants, is specifically designed to conform to the sinus ostia (openings), focusing drug delivery and mechanical support where it is needed in order to maximise sinus surgery outcomes. The implant features a low-profile flexible delivery system to make it easier to access tight areas of the sinus anatomy.

“The approval of PROPEL Contour adds a third product under the PROPEL umbrella, expanding our offering of steroid releasing implants to improve surgical outcomes,” said Lisa Earnhardt, president and CEO of Intersect ENT.

“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 customise treatment based on their patients’ disease and anatomy will ultimately lead to broader overall usage.”

Positive data from the PROPEL Contour cohort of the PROGRESS study, a prospective, randomised, blinded, multi-center trial of 80 patients designed to assess the safety and efficacy of the implant when placed in the frontal sinuses following surgery, supported the approval.

The study met its primary efficacy endpoint, demonstrating a statistically significant 65% relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or the need for oral steroid prescription, compared to surgery alone.

“The introduction of PROPEL steroid releasing implants has led to meaningful benefits in how we as surgeons manage our patients, especially by reducing our reliance on oral steroids to prevent post-operative complications,” said Robert Weiss, M.D., director and founder of CT ENT Sinus and Allergy Hearing and Balance in Norwalk, Conn., and one of the PROGRESS study investigators.

“With PROPEL Contour, we are able to offer those benefits to a significant range of our chronic sinusitis patients, regardless of their unique anatomy, and to do so with the comfort of the same rigorous clinical evidence for which the PROPEL family of products is known. With this base of solid evidence pointing to a clear benefit, there are strong reasons to include PROPEL as part of standard clinical practice.”

The company expects to launch PROPEL Contour broadly in the second quarter of 2017 and maintains its previously stated 2017 revenue guidance of $87-$89 million.

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