FDA Clears Elevo Kit Snoring Intervention Device
The Elevo device allows for lift to the soft palate, thereby expanding the diameter of the airway.
Zelegent, in collaboration with Cook Medical, has received clearance from the Food and Drug Administration (FDA) to market the Elevo Kit Snoring Intervention Device for use in the treatment of symptomatic, habitual, and social snoring due to palatal flutter.
The Elevo device allows for lift to the soft palate, thereby expanding the diameter of the airway, using proprietary sutures; these specially-shaped sutures are then naturally dissolved by the body. The procedure, known as Elevoplasty, was investigated in the S.I.L.E.N.C.E. study (Snoring Intervention via Elevoplasty in a Non-surgical Clinical Environment) which included 52 patients.
Cook Medical will be handling physician training on Elevo later this year. The minimally-invasive procedure can be performed in the office setting under local anesthesia.
“Elevoplasty is like a mini-face lift for the soft palate,” said Alexander K. Arrow, MD, chief executive officer of Zelegent. “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.”
For more information, visit Cook Medical.