WESTMINSTER, Colo., July 12 10, 2022 (GLOBE NEWSWIRE) — ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental and spine markets, today announced that Anthem Blue Cross Blue Shield (BCBS), a subsidiary/operating company of Elevance Health, issued an affirmative medical policy ruling applicable to anterior vertebral body tethering (AVBT), effective July 6, 2022. The ruling extends potential treatment eligibility to patients listed for AVBT among the more than 30 million members covered by Anthem BCBS, and outlines the medical necessity criteria that must be met for AVBT coverage.
“This decision marks an important victory for Anthem BCBS patients and for the broader pediatric scoliosis community,” said Rebecca Whitney, Senior Vice President and President of ZimVie Spine. “Before the development of the anterior vertebral body tether, the primary surgical option for children with scoliosis was spinal fusion with rigid rods that could limit mobility. Anthem’s coverage decision will provide children with better access to AVBT as a motion preservation alternative that could enable them to return to their active daily lives. We hope this decision will also pave the way for additional payer policy updates to positively impact the lives of children with scoliosis.
ZimVie’s Tether™ device, a first-of-its-kind fusionless scoliosis treatment, is the first and only FDA-cleared device for AVBT. Its Humanitarian Device Exemption (HDE) was granted based on more than seven years of clinical data validating the safety and effectiveness of The Tether in the correction of scoliosis. More than 1,200 children have received The Tether since HDE approval in August 2019, and approximately 50 US surgeons perform the procedure today.
“This policy change is a victory for families with scoliosis who need surgery, have researched their options, and chosen surgery that has the potential to maintain movement and reduce future complications,” said said Jaren Riley, MD, a board-certified fellow. -Trained pediatric orthopedic surgeon and the first in the Rocky Mountain region to perform vertebral body tethering. “I’m also grateful to Anthem BCBS for taking the time to meet with me personally and review the promising data I presented.”
Anthem’s policy decision can be viewed here: https://www.anthem.com/dam/medpolicies/abcbs/active/policies/mp_pw_a053519.html
For more information on ZimVie Spine solutions for restorative procedures, please visit https://www.zimvie.com/en/spine.html.
ZimVie is a global life science leader in the dental and spine markets that develops, manufactures and supplies a comprehensive portfolio of products and solutions designed to treat a wide range of spine pathologies and support the dental tooth replacement and restoration procedures. The company was founded in March 2022 as an independent, publicly traded spin-off of Zimmer Biomet’s Dental and Spine business units to breathe new life, dedicated energy and strategic direction into its brand and product portfolio of trust. From its headquarters in Westminster, Colorado, and additional facilities around the world, the company serves customers in more than 70 countries around the world with a strong offering of dental and spinal solutions, including product platforms differentiated supported by extensive clinical evidence.
For more information about ZimVie, please visit us at www.ZimVie.com. Follow @ZimVie on Twitter, Facebook, LinkedInWhere instagram.
The Tether is a humanitarian device. Authorized by federal law for use in the treatment of skeletally immature patients who require surgical treatment to achieve and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose bone structure is dimensionally adequate to allow screw fixation, as determined by radiographic imaging. Patients must have failed and/or be intolerant to wearing the splint. The effectiveness of this device for this use has not been demonstrated.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding expectations, plans, prospects and products and service offerings, including new product launches and potential clinical successes. These statements are based on management’s current beliefs, expectations and assumptions and are subject to important risks, uncertainties and changes in circumstances that could cause actual results to differ materially from the forward-looking statements. For a list and description of some of these risks and uncertainties, see ZimVie’s periodic reports filed with the United States Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements included in ZimVie’s filings with the SEC. Forward-looking statements speak only as of the date on which they are made, and ZimVie disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or other. Readers of this press release are cautioned not to rely on any such forward-looking statements, as there can be no assurance that such forward-looking statements will prove to be accurate. This cautionary statement applies to all forward-looking statements contained in this press release.
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