Intersect's new sinus implant receives FDA approval
Medical equipment company Intersect ENT has received the US Food and Drug Administration (FDA) approval for its steroid releasing sinus implant PROPEL Contour.
With an hourglass design, the implant allows treatment of patients with chronic sinusitis in the frontal and maxillary sinuses.
The latest approval enables use of the PROPEL line of steroid releasing implants to treat patients undergoing ethmoid, frontal or maxillary surgeries.
The PROPEL implants are designed to mechanically prop open the sinuses and release the steroid directly into the sinus lining then dissolve.
The Contour implant is developed to fit to the sinus ostia to enable drug delivery and mechanical support for maximum sinus surgery outcomes.
Its low-profile flexible delivery system allows easy access to tight areas of the sinus anatomy.
Intersect ENT president and chief executive officer 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 customise treatment based on their patients’ disease and anatomy will ultimately lead to broader overall usage.”
The firm has reported positive results from the prospective, randomised, blinded, multi-centre PROGRESS clinical trial of the PROPEL Contour.
The trial evaluated the safety and efficacy of the implant when placed in the frontal sinuses of 80 patients, after they have undergone surgery.
The company plans to launch PROPEL Contour in the second quarter of ths year.
Image: PROPEL Contour steroid releasing sinus implant. Photo: courtesy of Intersect ENT.