Frequently Asked Questions
This page outlines some of the most frequently asked questions regarding Zelegent and the Elevoplasty® procedure. Click on a question below to view the answer. For questions not answered on this page, please contact us.
Elevoplasty® is now available in the United States. You can undergo Elevoplasty as soon as you find a U.S. physician who has completed his/her training and offers the procedure. If your ENT physician does not yet offer Elevoplasty, encourage him/her to contact his/her local Cook Medical sales representative and arrange to attend an Elevoplasty training event.
The Snoring Intervention via Elevoplasty® in a Non-Surgical Clinical Environment (S.I.LE.N.C.E.) Study, sponsored by Zelegent, Inc., was a 2017-18 in-office clinical investigation of the Elevo® Set Snoring Intervention Device for the treatment of non-Obstructive Sleep Apnea (non-OSA) snoring.
The Elevo® suture implant is made of Polydioxanone, which is known to fully resorb in tissue in six months.
Elevoplasty® is now available in the United States. If your ENT physician does not yet offer the procedure, encourage him/her to contact his/her local Cook Medical sales representative and arrange to attend an Elevoplasty® training event.
The ‘Z’ is evocative of sleep. Zelegent rhymes with intelligent and sounds somewhat like elegant, which fits our mission to create the most elegant, simple-to-use, effective and desirable snoring-corrective surgical tool. Also, the name contains ENT, like successful ENT companies Acclarent, Entellus, ENTrigue, and Intersect ENT.
Elevoplasty has been shown in an 8-center, 52-patient U.S. clinical study to safely and effectively reduce snoring in some patients without sleep apnea. The procedure avoids the drawbacks of most other snoring interventions, because it does not require the patient to wear a nighttime appliance, does not rely on moving the tongue, and does not involve surgery nor general anesthesia.
Elevoplasty® avoids the drawbacks of most other snoring interventions, because it does not require the patient to wear a nighttime appliance, does not rely on moving the tongue, and does not involve surgery nor general anesthesia.
Elevoplasty™ is performed as an outpatient, in-office procedure, with no general anesthesia. We may be able to comment more specifically on the mean procedure time after the FDA review of the data from the multi-center S.I.LE.N.C.E. clinical trial.
No. The Elevoplasty™ procedure is expected to be an entirely non-reimbursed procedure. In this respect, it should be thought of economically like an elective self-improvement procedure, such as cosmetic plastic surgery.