The FDA has approved a pre-market approval (PMA) application from Intersect ENT for its Propel mometasone furoate drug delivery implant for the treatment of chronic sinusitis. The dissolvable device is inserted in the sinus cavity during surgery and maintains the opening of the ethnoid sinus while it delivers the corticosteroid to the sinus lining.
David W. Kennedy, professor of Otorhinolaryngology at the University of Pennsylvania Health System said, “Propel reduces the occurrence of inflammation and scarring in the post-operative period. As a result, it promises to substantially improve long-term outcomes for sinus surgery and, as my research has demonstrated, reduced scarring and inflammation correlates with absence of the need for further surgery. I believe the combination of minimally invasive techniques and local drug delivery will be the wave of the future in sinus treatment.”
Intersect President and CEO Lisa Earnhardt commented, “The FDA approval of Propel marks an exciting milestone for Intersect ENT as well as sinus sufferers and their physicians who will now have an important new treatment option, clinically
proven to maintain the benefits of sinus surgery.” The company plans to launch the product in the fall of 2011.
Read the Intersect ENT press release.
