The Tether™ gadget now deemed “medically needed” for the therapy of pediatric scoliosis in further sufferers coated by Highmark and BCBS North Dakota.
WESTMINSTER, Colo., March 15, 2023 (GLOBE NEWSWIRE) — ZimVie Inc. (Nasdaq: ZIMV), a world life sciences chief within the dental and spine markets, at this time introduced that Highmark, one in all America’s main medical insurance organizations and an impartial licensee of the Blue Cross Blue Defend Affiliation, which covers primarily Pennsylvania, New York, Delaware, and West Virginia, and BCBS North Dakota, the biggest payer within the state of North Dakota, have issued optimistic medical coverage choices relevant to vertebral physique tethering (VBT). Efficient January 30, 2023 for Highmark and March 6, 2023 for BCBS North Dakota, the insurance policies define the standards for medical necessity and develop potential therapy eligibility to sufferers indicated for VBT throughout the 4+ million members coated below Highmark and the 280,000+ lives coated by BCBS North Dakota.
“The Highmark and BCBS North Dakota protection choices validate the expectation we famous after we introduced the Anthem BCBS optimistic protection determination in July, that further coverage updates would comply with. It’s encouraging to see broader endorsement of this chance to positively affect the lives of youngsters with scoliosis via a movement preserving various to spinal fusion,” stated Rebecca Whitney, SVP and President of World Backbone for ZimVie. “We’re honored to work with orthopedic and neurosurgeons to develop vertebral physique tethering options that will enable kids with scoliosis to return to their energetic every day lives.”
ZimVie’s Tether™ gadget, a first-of-its-kind non-fusion scoliosis therapy, is the primary and solely FDA-approved gadget for VBT. Its humanitarian gadget exemption (HDE) was granted primarily based on over seven years of scientific information validating the protection and effectiveness of The Tether in scoliosis correction. Over 1,300 kids have obtained The Tether since HDE approval in August of 2019, with roughly 65 U.S. surgeons performing the process at this time.
“Highmark’s current optimistic coverage determination for vertebral physique tethering highlights the developments which have come via diligent analysis in understanding the optimum affected person indications for this promising know-how,” stated Amer Samdani, M.D., board-certified neurosurgeon, chief of surgical procedure for Shriners Hospitals for Kids – Philadelphia, and pioneer in vertebral physique tethering. “As VBT depends on remaining progress potential, I’m thrilled that this well timed approval will enable an elevated pediatric affected person inhabitants to entry therapy with out lacking the window of alternative.”
Highmark’s coverage determination could be discovered right here:
https://securecms.highmark.com/content material/medpolicy/en/highmark/wv/business/insurance policies/Surgical procedure/S-279/S-279-001.html
The BCBS North Dakota coverage determination could be discovered right here:
For extra data on ZimVie Backbone options for restorative procedures, please go to https://www.zimvie.com/en/spine.html.
ZimVie is a world life sciences chief within the dental and spine markets that develops, manufactures, and delivers a complete portfolio of merchandise and options designed to deal with a variety of spine pathologies and assist dental tooth alternative and restoration procedures. The corporate was based in March 2022 as an impartial, publicly traded spin-off of the Dental and Backbone enterprise items of Zimmer Biomet to breathe new life, devoted vitality, and strategic focus to its portfolio of trusted manufacturers and merchandise. From its headquarters in Westminster, Colorado, and extra amenities across the globe, the corporate serves clients in over 70 nations worldwide with a strong providing of dental and spine options together with differentiated product platforms supported by intensive scientific proof.
For extra details about ZimVie, please go to us at www.ZimVie.com. Comply with @ZimVie on Twitter, Fb, LinkedIn, or Instagram.
The Tether is a Humanitarian Gadget. Licensed by Federal regulation to be used within the therapy of skeletally immature sufferers that require surgical therapy to acquire and keep correction of progressive idiopathic scoliosis, with a significant 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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Media Contact Info:
Laura Driscoll • Laura.Driscoll@ZimVie.com
Mark Richards • Mark.Richards@ZimVie.com
Investor Contact Info:
Gilmartin Group LLC
Marissa Bych • Marissa@gilmartinir.com