Bloomington, Ind., and La Jolla, Calif. – Cook Medical and Zelegent, Inc. today announced results from the Snoring Intervention via Elevoplasty in a Non-surgical Clinical Environment (S.I.Le.N.C.E.) clinical trial. The study was recently published in the peer-reviewed journal, Laryngoscope Investigative Otolaryngology.
The study featured 52 participants receiving Elevoplasty®, the procedure performed using the Elevo® Snoring Intervention Device, in physician offices at eight US-based centers. Prior to receiving Elevoplasty, home sleep tests were performed to measure the participants’ snoring severity, such as the snoring visual analog scale (sVAS), as well as industry-wide sleep evaluations–the Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI). These measurements were all repeated at 30, 90, and 180 days post-procedure.1
The results demonstrated a 30.3% reduction in sVAS at 180 days post-procedure. Three out of four patients also saw a reduction in snoring 30 days after having the procedure. On average, patients saw a reduction in daytime sleepiness and an improvement in sleep quality.1
The study concluded that “the current study demonstrates the safety and efficacy of the Elevoplasty procedure in reducing snoring severity over a follow-up period of six months.”1
“Elevoplasty satisfies many of the priorities both patients and physicians have when seeking to reduce snoring severity,” said M. Boyd Gillespie, MD, professor and chair of the Department of Otolaryngology–Head and Neck Surgery at the University of Tennessee Health Science Center. “This recently published clinical evidence supports the effectiveness of the procedure, shows that it can be performed in the office, and allows patients to return to their regular diet and lifestyle post-procedure.”
Elevo’s delivery tool allows physicians to place specially shaped suture implants that provide lift to the soft palate and then are naturally dissolved by the body.2 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.1 This procedure can be performed under local anesthesia in an office setting without the need for surgery.
“Effective snoring management requires a comprehensive, multi-level approach,” said Gillespie. “Elevoplasty fits into this paradigm by reducing snoring at the palatal level.”
Physicians must complete training prior to purchasing Elevo. Physicians who are interested in attending an Elevo product training, want to learn more about Elevoplasty, or want to connect with your local Cook sales representative, visit CookMedical.com/Snoring.
Elevo and Elevoplasty are registered trademarks of Zelegent, Inc.
Dr. Gillespie is a paid consultant of Cook Medical and has a financial interest in Zelegent, Inc.
About Zelegent, Inc.
Zelegent, Inc., is a medical technology manufacturer founded and majority-owned by sleep disorder specialist physicians to create innovative tools to treat sleep disorders. The company developed and grew in the EvoNexus corporate incubator. The company’s mission is to develop and provide minimally invasive devices to effectively alleviate snoring and snoring-related sleep disorders. Elevoplasty is a patented, office-based procedure for sale in the United States, sold to physicians by Cook Medical, Inc. For updates, find Zelegent online at zelegent.com, or on Facebook, Twitter, LinkedIn and Pinterest.
About Cook Medical
Since 1963, Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: our patients, our employees, and our communities. Find out more at CookMedical.com, and for the latest news, follow us on Twitter, Facebook and LinkedIn.
1. Friedman M, Gillespie MB, Shabdiz FA, et al. A new office-based procedure for treatment of snoring: the S.I.Le.N.C.E. study. Laryngoscope Investig Otolaryngol. 2020;5(1):24–30.
2. Elevo kit snoring intervention device. Premarket notification 510(k) K181107.
