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By AMANDA PEDERSEN

Medical Device Daily Senior Staff Writer

A company focused on selling a drug-releasing implant for chronic sinusitis patients has received premarket approval (PMA) from the FDA for its Propel mometasone furoate implant offering localized, controlled drug delivery for chronic sinusitis patients.

Chronic sinusitis is a condition in which patients' sinuses become swollen and inflamed, leading to difficulty breathing, facial pain or headache, and reduced sense of smell and taste. The condition is common, affecting one in seven adults in the U.S., and greatly impacts quality of life, Intersect ENT (Palo Alto, California) noted.

"We're obviously very excited to be at this point, I see ENT as an area of huge unmet clinical need," Lisa Earnhardt, president/CEO of Intersect ENT, told Medical Device Daily.

The company's device, Propel, is designed to maintain sinus patency after surgery by propping open the sinuses in a spring-like fashion and providing for safe, effective and localized delivery of steroid directly to the sinus lining. The self-expanding implant conforms to the highly variable sinus anatomy then effectively delivers anti-inflammatory medication where it's needed most as the implant dissolves.

Safety and efficacy of the Propel implant has been studied in three prospective clinical trials conducted in the U.S. enrolling a total of 205 patients. These trials include a randomized double-blind Pilot Study, the ADVANCE safety study, and the ADVANCE II randomized, double-blind clinical trial. Results from the ADVANCE II study, which will be presented at the annual American Academy of Otolaryngology-Head and Neck Surgery (Alexandria, Virginia) conference in San Francisco, and findings from a meta-analysis of data from the pilot study and from ADVANCE II will be announced in September, the company said.

Earnhardt said there is no question sinus surgery is effective, but that most patients experience a reoccurrence of symptoms within the first year of surgery and that as many as 25% undergo revision surgery due to recurrent obstruction of the sinus cavity. So Intersect ENT's goal with the product was to improve post-operative outcomes.

"The device itself is implanted as delivery system very easily in the sinus cavity," Earnhardt said. She added that it's easy for the surgeon to implant and that patients don't actually feel the device once it's in.

The company plans to launch the Propel device in select U.S. markets this fall to gain commercial experience and real-life usage of the product before a full market launch.

"One of the things that make it so unique is it's the first and only product approved to deliver steroid in a safe and controlled fashion to the sinuses," Earnhardt said. She calls it both a mechanical and a medical benefit compared to current methods of delivery, including oral steroids which are associated with significant side effects, and topical steroid sprays that work fine for allergies but don't get the drug far enough into the sinus cavity for it to be effective for sinusitis patients.

Earnhardt also said that the company's PMA pathway was pretty straightforward, which she says is a "good sign" for others in the space.

Propel is the first of a new category of products offering localized, controlled delivery of steroid directly to the sinus tissue, the company noted. Inserted by a physician following endoscopic sinus surgery, 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 to maintain sinus patency.

"The FDA approval of this innovative new product is great news for ENT clinicians and patients," said David Kennedy, MD, a professor of otorhinolaryngology at the University of Pennsylvania Health System (Philadelphia). "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."

"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," Earnhardt said. "We look forward to launching our product to clinicians and their patients in select U.S. locations this fall."

Amanda Pedersen, 912-660-2282
amanda.pedersen@ahcmedia.com



Published  August 22, 2011

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