Bloomington, Ind., and La Jolla, Calif. – Cook Medical and Zelegent, Inc., are now training physicians throughout the U.S. on the Elevo® Snoring Intervention Set after it received FDA 510(k) clearance in January. The set is used to treat snoring at a palatal level, and it expands treatment options for snoring. Elevo was officially introduced at the International Surgical Sleep Society (ISSS) annual meeting. Earlier this year, Cook Medical and Zelegent, Inc., announced an agreement which would position Cook Medical to coordinate global sales, marketing, training, and distribution support.
During the ISSS annual meeting, Cook hosted a lunch symposium for more than 400 physicians, led by M. Boyd Gillespie, MD, and Yosef P. Krespi, MD, FACS. Drs. Gillespie and Krespi presented the proper use of the Elevo Snoring Intervention Set, the benefits and risks of the Elevoplasty® procedure, and the importance of patient selection.
“It’s the first new office-based product for snoring to come out in over 10 years and has some unique design advantages compared to previous treatments,” said Dr. Gillespie, professor and chair of the Department of Otolaryngology–Head and Neck Surgery at the University of Tennessee Health Science Center. “The thing that gets me excited about Elevo is that it’s office-based, doesn’t involve tissue removal or a permanent implant, and deals with one of the main issues of snoring, which is tissue laxity.”
Cook and Zelegent, Inc., have begun to host a series of Vista® training courses across the U.S. that will continue throughout 2019. These courses are designed to give attendees the knowledge and practical skills they will need to feel confident with the product during their first Elevoplasty patient cases.* Participating in the practical course should equip physicians with the knowledge and expertise that they need to bring this procedure to their practice.
“We had physicians who were able to witness four live cases with the Elevo Snoring Intervention Set, all of which were performed in an office setting,” said Thomas Cherry, MedSurg global business leader. “Throughout these training courses, there was a tremendous amount of excitement and engagement from both the presenting surgeons and attendees. This was a highly encouraging beginning to our educational program for Elevo.”
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. 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. This procedure can be performed under local anesthesia in an office setting without the need for surgery.1
*Please note that a physician must complete product training prior to purchasing Elevo.
Elevo and Elevoplasty are registered trademarks of Zelegent, Inc.
Dr. Boyd Gillespie is a paid consultant of Cook Medical and has a financial interest in Zelegent, Inc.
Dr. Yosef Krespi is a consultant of Cook Medical and has a financial interest in Zelegent, Inc.
. Elevo kit snoring intervention device. Premarket notification 510(k) K181107. Submitted by Zelegent, Inc. Prepared December 3, 2018.