Intersect ENT, based in Menlo Park, California, is releasing in the U.S. its SINUVA sinus implant for treating nasal polyp disease in adults that underwent previous surgical sinus procedures. The device elutes mometasone furoate, a corticosteroid, to reduce inflammation directly at the polyps. The drug is released for approximately 90 days after the SINUVA is implanted in an in-office procedure.
“After years of development and multiple clinical studies, we are thrilled to provide physicians with SINUVA to treat patients with nasal polyps. SINUVA offers an alternative to patients who have exhausted routine medical management who don’t want to return to the operating room for a repeat surgery,” in a statement said Lisa Earnhardt, president and CEO of Intersect ENT. “We are introducing SINUVA through a targeted launch, working to build success through positive initial adoption and positioning SINUVA for the long-term growth we believe is achievable.”
Some details about an important study of the SINUVA, according to Intersect ENT:
The efficacy of the SINUVA Sinus Implant was demonstrated in the landmark RESOLVE II pivotal study in 300 patients who were indicated for repeat sinus surgery. RESOLVE II met both co-primary efficacy endpoints as patients receiving SINUVA experienced (1) a statistically significant reduction from baseline to 90 days in bilateral polyp grade (p=0.007), which corresponded to 74% relative reduction in the extent of ethmoid polyp disease; and (2) a significant reduction from baseline to 30 days in nasal obstruction/congestion score (p=0.007), which corresponded to 30% relative improvement, compared to controls. Four of the five pre-specified secondary endpoints achieved statistical significance through day 90 favoring the SINUVA group, including reduction in percent ethmoid sinus obstruction, reduction of nasal obstruction/congestion symptoms, improvement in sense of smell, and reduction in the proportion of patients still indicated for repeat sinus surgery.
Product page: SINUVA…
Via: Intersect ENT…
