The Tether™ gadget now thought of “medically obligatory” for remedy of pediatric scoliosis.
WESTMINSTER, Colo., July 12, 2022 (GLOBE NEWSWIRE) — ZimVie Inc. (Nasdaq: ZIMV), a world life sciences chief within the dental and backbone markets, at the moment introduced that Anthem Blue Cross Blue Protect (BCBS), a subsidiary/working firm of Elevance Health, has issued a constructive medical coverage determination relevant to anterior vertebral physique tethering (AVBT), efficient July 6, 2022. The choice expands potential remedy eligibility to sufferers indicated for AVBT inside the 30+ million members coated below Anthem BCBS, and descriptions the medical necessity standards that should be met for protection of AVBT.
“This determination marks a big win for Anthem BCBS sufferers and the broader pediatric scoliosis neighborhood,” stated Rebecca Whitney, SVP and President of ZimVie Backbone. “Earlier than the event of anterior vertebral physique tethering, the first surgical possibility for youngsters with scoliosis was a spinal fusion with inflexible rods that would restrict mobility. The protection determination from Anthem will present youngsters with higher entry to AVBT as a movement preserving different that will enable them to return to their lively every day lives. We hope that this determination additionally paves the way in which for coverage updates from extra payers to positively impression the lives of kids with scoliosis.”
ZimVie’s Tether™ gadget, a first-of-its-kind non-fusion scoliosis remedy, is the primary and solely FDA-approved gadget for AVBT. Its humanitarian gadget exemption (HDE) was granted primarily based on over seven years of scientific information validating the security and effectiveness of The Tether in scoliosis correction. Over 1,200 youngsters have obtained The Tether since HDE approval in August of 2019, with roughly 50 U.S. surgeons performing the process at the moment.
“This coverage change is a victory for households with scoliosis who want surgical procedure, have researched their choices, and have chosen a surgical procedure that has the potential to take care of movement and reduce future issues,” stated Jaren Riley, M.D., a board-certified, fellowship-trained pediatric orthopedic surgeon and the primary within the Rocky Mountain Area to carry out vertebral physique tethering. “I’m additionally grateful to Anthem BCBS for taking the time to satisfy with me personally and study the promising information I introduced.”
Anthem’s coverage determination will be discovered right here: https://www.anthem.com/dam/medpolicies/abcbs/lively/insurance policies/mp_pw_a053519.html
For extra info on ZimVie Backbone options for restorative procedures, please go to https://www.zimvie.com/en/backbone.html.
ZimVie is a world life sciences chief within the dental and backbone markets that develops, manufactures, and delivers a complete portfolio of merchandise and options designed to deal with a variety of backbone pathologies and assist dental tooth alternative and restoration procedures. The corporate was based in March 2022 as an unbiased, publicly traded spin-off of the Dental and Backbone enterprise items of Zimmer Biomet to breathe new life, devoted power, and strategic focus to its portfolio of trusted manufacturers and merchandise. From its headquarters in Westminster, Colorado, and extra services across the globe, the corporate serves prospects in over 70 international locations worldwide with a sturdy providing of dental and backbone options together with differentiated product platforms supported by in depth scientific proof.
For extra details about ZimVie, please go to us at www.ZimVie.com. Observe @ZimVie on Twitter, Fb, LinkedIn, or Instagram.
The Tether is a Humanitarian System. Licensed by Federal legislation to be used within the remedy of skeletally immature sufferers that require surgical remedy to acquire and preserve correction of progressive idiopathic scoliosis, with a serious Cobb angle of 30 to 65 levels whose osseous construction is dimensionally enough to accommodate screw fixation, as decided by radiographic imaging. Sufferers ought to have failed bracing and/or be illiberal to brace put on. The effectiveness of this gadget for this use has not been demonstrated.
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