Determination clears the best way for enrollment of U.S. sufferers in a groundbreaking medical examine of cervical arthroplasty adjoining to fusion
WESTMINSTER, Colo., Sept. 26, 2023 /OrthoSpineNews/ — ZimVie Inc. (Nasdaq: ZIMV), a world life sciences chief within the dental and spine markets, immediately introduced that on September 7, 2023, the U.S. Food and Drug Administration accepted its Mobi-C® Cervical Disc Hybrid Investigational Machine Exemption (IDE) software. The choice authorizes ZimVie to start enrolling U.S. sufferers within the examine, which can observe sufferers who obtain simultaneous cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) at adjoining ranges between C3 and C7. In some circumstances, the very best two-level remedy could also be simply such a hybrid assemble, the place the disc alternative and fusion will be accomplished in a single surgical procedure, offering a medical profit to the affected person and surgeon in addition to an financial profit to stakeholders within the healthcare supply system. Surgeons have implanted over 200,000 Mobi-C implants for cervical disc alternative at one degree or two contiguous ranges since 2004. In 2013, Mobi-C turned the primary cervical disc accepted for one and two ranges by the FDA and stays the market-leading machine for cervical disc alternative.
Not like some aggressive implants, the Mobi-C cervical disc options low-profile endplates that don’t require keel cuts or extra {hardware} that would intrude with implants at an adjoining degree. This has made Mobi-C a compelling selection for surgeons performing two-level disc alternative, and can probably show enticing in hybrid constructs with fusion at an adjoining degree.
Kee D. Kim, M.D., Professor and Chief of Spinal Neurosurgery on the College of California, Davis, and one of many investigators within the examine, shared, “The FDA approval of the IDE software will enable us to maneuver ahead with this necessary examine. Good medical knowledge is a crucial step in broadening the accepted indications for cervical disc alternative in hybrid constructs with fusion at an adjoining degree. I’m delighted to be a part of this groundbreaking examine, which can in the end result in extra sufferers having access to probably the most applicable remedy.”
“The choice to maneuver ahead with the Mobi-C hybrid examine demonstrates our ongoing management and vital funding in persevering with to develop the cervical arthroplasty market,” stated Rebecca Whitney, International President of ZimVie Backbone. “We’re dedicated to and enthusiastic about driving the growth of this market to supply a higher variety of sufferers with the present of movement. We’re happy to be on the forefront of necessary medical research to make movement preservation a actuality for extra sufferers.”
The corporate intends to start enrollment over the subsequent a number of months and conduct the IDE examine with a number of surgeons at six websites over the subsequent 5 years.
In regards to the Mobi-C Cervical Disc
Mobi-C is the primary cervical disc prosthesis accepted 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 resembling 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 attributable to abnormality localized to the extent of the disc house 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 method. Sufferers ought to have failed a minimum of six weeks of conservative remedy or demonstrated progressive indicators or signs regardless of nonoperative remedy previous to implantation of the Mobi-C Cervical Disc Prosthesis.
Frequent post-operative dangers from surgical procedure with the Mobi-C embrace ache within the neck, arm, again, shoulder, or head, and dysphagia. For full indications, contraindications, warnings, and dangers of 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 impartial, publicly traded spin-off of the Dental and Backbone enterprise models 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 prospects in over 70 international locations worldwide with a strong providing of dental and spine options together with differentiated product platforms supported by in depth medical proof.
For extra details about ZimVie, please go to us at www.ZimVie.com. Observe @ZimVie on Twitter, Fb, LinkedIn, or Instagram.
Cautionary Word Concerning Ahead-Wanting Statements
This press launch comprises forward-looking statements throughout the which means of the secure harbor provisions of the Non-public Securities Litigation Reform Act of 1995. Ahead-looking statements embrace, however aren’t 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 based mostly upon the present beliefs, expectations, and assumptions of administration and are topic to vital dangers, uncertainties, and adjustments in circumstances that would trigger precise outcomes and outcomes to vary materially from the forward-looking statements. For a listing and outline of a few of such dangers and uncertainties, see ZimVie’s periodic studies filed with the U.S. Securities and Change Fee (SEC). These components shouldn’t be construed as exhaustive and must be learn along side the opposite cautionary statements which are 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 will 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
Discussion about this post