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.
Not yet. The Elevo™ Kit is an investigational device only and is not for sale in the United States. Elevoplasty™ procedures were performed in six cities in the multi-center S.I.LE.N.C.E. clinical trial in 2017. The outcomes data from this trial are being collected and will form the basis of a 510(k) application to the U.S. FDA in 2018. If the FDA grants a 510(k) clearance, then Zelegent will begin offering a training program for U.S. ENT physicians. Those physicians who have completed this training will then be able to offer Elevoplasty™ to their patients.
The Snoring Intervention via Elevoplasty™ in a Non-Surgical Clinical Environment (S.I.LE.N.C.E.) Study, sponsored by Zelegent, Inc., is an in-office clinical investigation of the Elevo™ Kit Snoring Intervention Device for the treatment of non-Obstructive Sleep Apnea (non-OSA) snoring. The Elevo™ Kit Snoring Intervention Device is an Investigational Device. CAUTION — INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (UNITED STATES) LAW TO INVESTIGATIONAL USE.
That is currently under investigation in the multi-center S.I.LE.N.C.E. clinical trial. We anticipate having the answer in mid-2018.
Today, you cannot. If the FDA grants a 510(k) clearance, then Zelegent will begin offering a training program for U.S. ENT physicians. Those physicians who have completed this training will then be able to offer Elevoplasty™ to their patients. At that time, Zelegent may offer a list of Elevoplasty™ trained physicians on its website.
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.
We anticipate being able to answer this question after the results of the multi-center S.I.LE.N.C.E. clinical trial have been made public.
This is a fair question, which we anticipate being able to answer after the results of the multi-center S.I.LE.N.C.E. clinical trial have been made public.
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.