FDA approves first drug-eluting implant for chronic sinusitis | Regulatory Roundup

August 16, 2011 by MassDevice staff

Intersect ENT touts a landmark PMA win for its Propel implanted drug-delivery device for treatment of chronic sinusitis.

Intersect ENT

Intersect ENT Inc. announced a landmark win for its flagship Propel drug-eluting implant for treatment of chronic sinusitis.

The Palo Alto, Calif.-based company's device claims to be the first of a new category of devices offering localized, controlled steroid delivery directly to sinus tissue.

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 a press release. While surgery is often effective, as many as 25 percent of patients require revision surgery to clear recurrent obstruction of the airways.

Propel is implanted during sinus surgery, propping open the sinuses in a "spring-like" fashion that conforms to the individual's cavity to delivery anti-inflammatory medication as the implant dissolves.

Intersect closed a $30 million funding round joined by Medtronic Inc. (NYSE:MDT) in November 2010.

Regulatory Roundup