ZimVie Announces Over 2,000 Children Have Received The Tether™ VBT
- Over 2,000 children worldwide have been treated with The Tether™ Vertebral Body Tethering System, a milestone achievement for ZimVie Inc.
- The Tether™ was approved as a Humanitarian Device by the FDA in 2019, based on over seven years of clinical data.
- Fifty surgeons have performed VBT using The Tether™ system to treat patients diagnosed with adolescent idiopathic scoliosis.
- None.
WESTMINSTER, Colo., Oct. 24, 2023 (GLOBE NEWSWIRE) -- ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental and spine markets, today announced that over 2,000 children worldwide have been treated with The Tether™ Vertebral Body Tethering System. The Tether was approved as a Humanitarian Device by the FDA in 2019, based on over seven years of clinical data. Over fifty surgeons have performed VBT using the market-leading Tether system to treat patients diagnosed with adolescent idiopathic scoliosis.
Dr. Baron Lonner, Chief of Minimally Invasive Scoliosis Surgery and Pediatric Spine at Mount Sinai Hospital and Professor of Orthopaedic Surgery at Icahn School of Medicine in New York, shared, “I have been in practice dedicating my career to the treatment of patients with scoliosis for 28 years. The Tether has been an amazing advance that has allowed my patients to have correction of their scoliosis while avoiding a fusion, with a faster return to sports and other activities. It has been a game changer.”
“Having brought this technology to over 2,000 children is a milestone that serves as a reminder of our commitment to put patients first, especially those for whom our products can have such profound and prolonged impact,” added Rebecca Whitney, Global President of ZimVie Spine. “The Tether is an important and inspirational part of our motion preservation portfolio. We remain dedicated to developing the market for vertebral body tethering and restoring daily life for this special group of patients.”
About The Tether™
The Tether is a Humanitarian Device authorized by Federal law for use in the treatment of skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear. The effectiveness of this device for this use has not been demonstrated. Post-operative risks include inadequate curve correction, overcorrection of the instrumented curve, cord breakage, and bone screw migration. Full contraindication and risk information can be found at myscoliosis.com.
About ZimVie
ZimVie is a global life sciences leader in the dental and spine markets that develops, manufactures, and delivers a comprehensive portfolio of products and solutions designed to treat a wide range of spine pathologies and support dental tooth replacement and restoration procedures. The company was founded in March 2022 as an independent, publicly traded spin-off of the Dental and Spine business units of Zimmer Biomet to breathe new life, dedicated energy, and strategic focus to its portfolio of trusted brands and products. From its headquarters in Westminster, Colorado, and additional facilities around the globe, the company serves customers in over 70 countries worldwide with a robust offering of dental and spine solutions including differentiated product platforms supported by extensive clinical evidence. For more information about ZimVie, please visit us at www.ZimVie.com. Follow @ZimVie on Twitter, Facebook, LinkedIn, or Instagram.
Cautionary Note 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 concerning ZimVie’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs, expectations, and assumptions of management and are subject to significant risks, uncertainties, and changes in circumstances that could cause actual outcomes and results to differ materially from the forward-looking statements. For a list and description of some of such risks and uncertainties, see ZimVie’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in ZimVie’s filings with the SEC. Forward-looking statements speak only as of the date 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 otherwise. Readers of this press release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary note is applicable to all forward-looking statements contained in this press release.
Media Contact Information:
ZimVie
Laura Driscoll • Laura.Driscoll@ZimVie.com
(774) 284-1606
ZimVie Spine
Mark Richards • Mark.Richards@ZimVie.com
(512) 913-9572
Investor Contact Information:
Gilmartin Group LLC
Marissa Bych • Marissa@gilmartinir.com
FAQ
How many children have been treated with The Tether™ Vertebral Body Tethering System?
When was The Tether™ approved by the FDA?
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