ZimVie Announces First U.S. Surgery with the 4.5mm Mobi-C® Cervical Disc
WESTMINSTER, Colo., Oct. 31, 2023 (GLOBE NEWSWIRE) -- ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental and spine markets, today announced that the first patient in the United States has received the newly approved 4.5mm Mobi-C® Cervical Disc. Introduced in France in 2004, Mobi-C became the first cervical disc approved for one and two levels by the FDA in 2013. The smaller 4.5mm height Mobi-C implants, available in seven footprints to match patient anatomy, were approved by the FDA in August of this year.
On October 30, 2023, Gregory D. Lopez, M.D., orthopaedic spine surgeon with Midwest Orthopaedics at Rush in Chicago, Illinois, implanted the first 4.5mm Mobi-C in the United States. “The 59-year-old patient presented with a significantly collapsed C5-6 disc, and the new lower profile Mobi-C implant allowed me to avoid over-distracting the facet joints. The 4.5mm height Mobi-C makes it possible for me to offer pain relief and motion preservation to more of my patients with cervical disc degeneration.”
“It is an honor to celebrate the first U.S. implantation of the 4.5mm Mobi-C Cervical Disc. ZimVie is dedicated to bringing the right products to the market, and it really hits home to know that patients are benefiting from our efforts,” said Rebecca Whitney, Global President of ZimVie Spine. “We are excited about the recent wins for our market-leading Mobi-C portfolio, including the August FDA approval for the 4.5mm range of implants and the September approval of the Mobi-C Hybrid Investigational Device Exemption (IDE) application, allowing ZimVie to enroll patients in the first ever cervical arthroplasty-fusion study in the United States.”
About the Mobi-C Cervical Disc
Mobi-C is the first cervical disc prosthesis approved by the FDA for reconstruction of a cervical disc at both one and two levels (C3-C7). Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that is inserted in a single step, without requiring bone chiseling or other vertebral anchorage such as screws or keels. The Mobi-C Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or neurological deficit) with or without neck pain or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C Cervical Disc Prosthesis.
Common post-operative risks from surgery with the Mobi-C include pain in the neck, arm, back, shoulder, or head, and dysphagia. For complete indications, contraindications, warnings, and risks of the Mobi-C Cervical Disc or to find more information on other ZimVie Spine solutions, please visit https://www.zimvie.com/en/spine.html.
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:
Laura Driscoll • Laura.Driscoll@ZimVie.com
Mark Richards • Mark.Richards@ZimVie.com
Investor Contact Information:
Gilmartin Group LLC
Marissa Bych • Marissa@gilmartinir.com