Sinuva Sinus Implant Launched to Treat Recurrent Nasal Polyps
Intersect ENT has announced that Sinuva (mometasone furoate) Sinus Implant is now available for patients ≥18 years of age to treat nasal polyp disease in those who have had previous ethmoid sinus surgery. The corticosteroid-eluting implant was approved last November by the Food and Drug Administration (FDA) based on data from clinical studies of 400 patients, including the RESOLVE II study.
Sinuva can be implanted during a routine physician visit under local or topical anesthesia. Once implanted, Sinuva expands into the sinus cavity and delivers the steroid directly to the site of polyp disease for 90 days.
"The clinical data supporting the use of the Sinuva implant is compelling. I believe this innovative treatment option will be attractive for many of my patients," said Satish Govindaraj, MD, Department of Otolaryngology of Mount Sinai Medical Center, one of the trial sites involved in the pivotal study of Sinuva.
Sinuva is made from bioabsorbable polymers designed to soften over time; as the implant softens and the polyps decrease, the implant may be expelled out of the nose via forceful nose blowing. The implant can also be removed earlier than 90 days at a physician's discretion, however repeat administration of Sinuva has not been investigated.
The most common adverse events with Sinuva in clinical trials were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis.
The American Rhinologic Society endorsed the use of drug-eluting sinus cavity implants in 2016.
For more information visit Sinuva.com.