Drug-eluting sinus implant gets FDA premarket approval

Palo Alto, CA-based Intersect ENT has earned FDA premarket approval for its Propel drug-eluting implant for treatment of chronic sinusitis. The company says Propel is the first in a new category of devices offering localized, controlled steroid delivery directly to sinus tissue. Inserted by a physician to maintain the surgical opening, the spring-like implant expands to prop open the sinus and gradually delivers an advanced corticosteroid with anti-inflammatory properties directly to the sinus lining as the implant dissolves, according to the company.

"Propel reduces the occurrence of inflammation and scarring in the post-operative period," David W. Kennedy, a researcher in functional endoscopic sinus surgery at the University of Pennsylvania Health System, said in a statement. "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."

In November 2010, the company raised $30 million with the help of new investor Medtronic and existing investors PTV Sciences, Kleiner Perkins Caufield & Byers and U.S. Venture Partners.

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- and a report in Mass Device