Drug-delivery devices maker Intersect ENT touted FDA approval for its 2nd-generation Propel mini implant, a smaller version of its previously approved device for treating chronic sinusitis.
The newly approved Propel mini will be offered in select U.S. hospitals this month, with full nationwide launch expected in 2013 alongside a planned sales force expansion, according to a press release.
The Menlo Park, Calif.-based device maker in August 2011 won FDA approval for the original Propel mometasone furoate implant, which was the 1st of a new category of devices offering localized, controlled steroid delivery directly to sinus tissue.
The Propel implants prop open a patient’s sinus in order to gradually deliver an advanced steroid with anti-inflammatory properties directly to the sinus lining, according to the company. The implant, which dissolves into the body over time, reduces the need for systemic steroid dosing and may prevent additional surgical procedures.
"We are excited that the significant clinical benefits of Propel will now be available to more patients suffering from chronic sinusitis, a condition that has a severe impact on quality of life," Intersect president & CEO Lisa Earnhardt said in prepared remarks. "Propel mini and Propel, clinically proven to maintain sinus patency after surgery, are the 1st and only products for patients undergoing sinus surgery to be backed by Level 1-A clinical evidence."
Chronic sinusitis is a common condition affecting on in seven U.S. adults and frequently requires a combination of surgical and medical treatments, according to the company. While surgery is often effective, as many as 25% of patients require revision surgery to clear recurrent obstruction of the airways.