In December, the FDA issued a 510(k) clearance for Zelegent Inc’s Elevo Kit Snoring Intervention Device.
The specialized tool is designed to enhance patient treatment options for snoring. Elevo’s delivery system allows placement of specially-shaped sutures that provide lift to the soft palate and then are naturally dissolved by the body. It is indicated for symptomatic, habitual, and social snoring due to palatal flutter.
Elevo is used in Elevoplasty, a procedure that provides lift and stiffening to the soft palate tissue in the mouth. Elevoplasty can be performed under local anesthesia in an office setting without the need for surgery.
Zelegent also recently announced a collaboration with Cook Medical to market the new device.
“Elevoplasty is like a mini-face lift for the soft palate,” says Alexander K. Arrow, MD, Zelegent CEO, in a release. “We are honored to have the Elevo product adopted into a minimally invasive and innovative Cook product portfolio whose reputation dates back to Cook’s early work supporting pioneering physicians.”
Cook will begin training physicians on the Elevo Kit later this year.