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www.fdanews.com/articles/172068-intersect-ent-enrolls-first-nova-sinus-implant-patient

Intersect ENT Enrolls First Nova Sinus Implant Patient

July 10, 2015

Menlo Park, Calif.-based Intersect ENT said it has enrolled the first patient in its pivotal study evaluating the drug-eluting Nova sinus implant.

The multicenter clinical trial will enroll 80 patients to assess the safety and efficacy of the implant, which releases a bioabsorbale steroid to clear the sinuses and reduce inflammation following surgery.

This trial serves as the second cohort of a larger study. The first cohort investigated Intersect ENT’s Propel mini drug-eluting implant, approved for ethmoid sinus, to expand its indication.

The FDA has designated the Nova implant for investigational use only. — Jason Scott