ZimVie Announces FDA Approval for New Mobi-C® Implant
10 8월 2023 - 9:00PM
ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the
dental and spine markets, today announced that on August 1st, 2023,
the U.S. Food and Drug Administration approved a smaller height of
the Mobi-C® Cervical Disc in seven footprints that will address the
anatomical needs of the U.S. patient population. Physicians have
used the market-leading Mobi-C device for cervical disc replacement
at one level or two contiguous levels to treat patients in France
since 2004 and in the U.S. since 2013 when it became the first
cervical disc approved for one and two levels by the FDA.
“The 4.5mm height implants are an important addition to the
Mobi-C lineup,” said Jad G. Khalil, M.D., orthopaedic spine surgeon
at Michigan Orthopaedic Solutions, PLLC. “Surgeons will be able to
use the prostheses in more significantly collapsed discs and avoid
over-distraction of the facet joints. This will expand the
indications for cervical disc arthroplasty and therefore more
patients can benefit from the clinically compelling Mobi-C Cervical
disc.”
Kee D. Kim, M.D., Professor and Chief of Spinal Neurosurgery at
the University of California, Davis underscores the clinical
importance of the approval. “Improper sizing of an artificial disc
can lead to problems such as prosthesis migration, subsidence, and
segmental kyphosis. We also found from our biomechanical study that
increasing the height of an artificial disc by just 1mm reduced the
range of motion at that level by around 50%. Even a 5mm height
artificial disc may be too tight for some patients. Therefore,
FDA approval of 4.5mm height Mobi-C disc is very good news for our
patients and allows greater flexibility for the surgeons to choose
the best fitting artificial disc.”
“The approval of the 4.5mm Mobi-C is a win for our surgeons and
their patients, as well as a validation of thoughtful strategy by
our global Regulatory Affairs team who utilized real-world clinical
evidence gained from EU studies to show long-term safety and
efficacy and secure the FDA approval for the smaller disc,” said
Rebecca Whitney, Global President of ZimVie Spine. “We are pleased
to provide surgeons the largest range of footprint and height
options in the market to bring motion preservation to their
patients. We will commercialize the product in the U.S. this
fall.”
About the Mobi-C Cervical DiscMobi-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 on the
Mobi-C Cervical Disc or to find more information on other ZimVie
Spine solutions, please visit
https://www.zimvie.com/en/spine.html.
About ZimVieZimVie 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
StatementsThis 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:
ZimVieLaura Driscoll •
Laura.Driscoll@ZimVie.com(774) 284-1606
ZimVie SpineMark Richards •
Mark.Richards@ZimVie.com(512) 913-9572
Investor Contact Information:
Gilmartin Group LLCMarissa Bych •
Marissa@gilmartinir.com
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