Smaller top implants in all Mobi-C footprints to handle affected person anatomy
WESTMINSTER, Colo., Aug. 10, 2023 (GLOBE NEWSWIRE) — ZimVie Inc. (Nasdaq: ZIMV), a world life sciences chief within the dental and spine markets, at the moment introduced that on August 1st, 2023, the U.S. Food and Drug Administration accredited a smaller top of the Mobi-C® Cervical Disc in seven footprints that may deal with the anatomical wants of the U.S. affected person inhabitants. Physicians have used the market-leading Mobi-C machine for cervical disc alternative at one degree or two contiguous ranges to deal with sufferers in France since 2004 and within the U.S. since 2013 when it grew to become the primary cervical disc accredited for one and two ranges by the FDA.
“The 4.5mm top implants are an necessary addition to the Mobi-C lineup,” mentioned Jad G. Khalil, M.D., orthopaedic spine surgeon at Michigan Orthopaedic Options, PLLC. “Surgeons will be capable to use the prostheses in additional considerably collapsed discs and keep away from over-distraction of the aspect joints. This can broaden the indications for cervical disc arthroplasty and subsequently extra sufferers can profit from the clinically compelling Mobi-C Cervical disc.”
Kee D. Kim, M.D., Professor and Chief of Spinal Neurosurgery on the College of California, Davis underscores the medical significance of the approval. “Improper sizing of a man-made disc can result in issues equivalent to prosthesis migration, subsidence, and segmental kyphosis. We additionally discovered from our biomechanical research that rising the peak of a man-made disc by simply 1mm decreased the vary of movement at that degree by round 50%. Even a 5mm top synthetic disc could also be too tight for some sufferers. Due to this fact, FDA approval of 4.5mm top Mobi-C disc is superb information for our sufferers and permits higher flexibility for the surgeons to decide on the very best becoming synthetic disc.”
“The approval of the 4.5mm Mobi-C is a win for our surgeons and their sufferers, in addition to a validation of considerate technique by our world Regulatory Affairs staff who utilized real-world medical proof gained from EU research to point out long-term security and efficacy and safe the FDA approval for the smaller disc,” mentioned Rebecca Whitney, World President of ZimVie Backbone. “We’re happy to offer surgeons the most important vary of footprint and top choices out there to carry movement preservation to their sufferers. We’ll commercialize the product within the U.S. this fall.”
Concerning the Mobi-C Cervical Disc
Mobi-C is the primary cervical disc prosthesis accredited by the FDA for reconstruction of a cervical disc at each one and two ranges (C3-C7). Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis that’s inserted in a single step, with out requiring bone chiseling or different vertebral anchorage equivalent to screws or keels. The Mobi-C Cervical Disc Prosthesis is indicated in skeletally mature sufferers for reconstruction of the disc from C3-C7 following discectomy at one degree or two contiguous ranges for intractable radiculopathy (arm ache and/or neurological deficit) with or with out neck ache or myelopathy as a result of abnormality localized to the extent of the disc area and a minimum of one of many following situations confirmed by radiographic imaging (CT, MRI or X-rays): herniated nucleus pulposus, spondylosis (outlined by the presence of osteophytes) and/or seen lack of disc top in comparison with adjoining ranges. The Mobi-C Cervical Disc Prosthesis is implanted utilizing an anterior strategy. Sufferers ought to have failed a minimum of six weeks of conservative therapy or demonstrated progressive indicators or signs regardless of nonoperative therapy previous to implantation of the Mobi-C Cervical Disc Prosthesis.
Widespread post-operative dangers from surgical procedure with the Mobi-C embody ache within the neck, arm, again, shoulder, or head, and dysphagia. For full indications, contraindications, warnings, and dangers on the Mobi-C Cervical Disc or to search out extra info on different ZimVie Backbone options, please go to https://www.zimvie.com/en/spine.html.
About ZimVie
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 help 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 spine options together with differentiated product platforms supported by intensive medical proof. For extra details about ZimVie, please go to us at www.ZimVie.com. Comply with @ZimVie on Twitter, Fb, LinkedIn, or Instagram.
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This press launch incorporates forward-looking statements throughout the that means of the protected harbor provisions of the Personal Securities Litigation Reform Act of 1995. Ahead-looking statements embody, however are usually not restricted to, statements regarding ZimVie’s expectations, plans, prospects, and product and repair choices, together with new product launches and potential medical successes. Such statements are primarily based upon the present beliefs, expectations, and assumptions of administration and are topic to important dangers, uncertainties, and adjustments in circumstances that might trigger precise outcomes and outcomes to vary materially from the forward-looking statements. For an inventory and outline of a few of such dangers and uncertainties, see ZimVie’s periodic studies filed with the U.S. Securities and Alternate Fee (SEC). These elements shouldn’t be construed as exhaustive and ought to be learn along with the opposite cautionary statements which might be included in ZimVie’s filings with the SEC. Ahead-looking statements converse solely as of the date they’re made, and ZimVie disclaims any intention or obligation to replace or revise any forward-looking statements, whether or not on account of new info, future occasions, or in any other case. Readers of this press launch are cautioned to not depend on these forward-looking statements, since there might be no assurance that these forward-looking statements will show to be correct. This cautionary be aware is relevant to all forward-looking statements contained on this press launch.
Media Contact Info:
ZimVie
Laura Driscoll • Laura.Driscoll@ZimVie.com
(774) 284-1606
ZimVie Backbone
Mark Richards • Mark.Richards@ZimVie.com
(512) 913-9572
Investor Contact Info:
Gilmartin Group LLC
Marissa Bych • Marissa@gilmartinir.com
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