ZimVie Announces FDA Approval to Launch Mobi-C® Hybrid Study
26 9월 2023 - 9:00PM
ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the
dental and spine markets, today announced that on September 7,
2023, the U.S. Food and Drug Administration approved its Mobi-C®
Cervical Disc Hybrid Investigational Device Exemption (IDE)
application. The decision authorizes ZimVie to begin enrolling U.S.
patients in the study, which will follow patients who receive
simultaneous cervical disc arthroplasty (CDA) and anterior cervical
discectomy and fusion (ACDF) at adjacent levels between C3 and C7.
In some cases, the best two-level treatment may be just such a
hybrid construct, where the disc replacement and fusion can be
completed in one surgery, providing a clinical benefit to the
patient and surgeon as well as an economic benefit to stakeholders
in the healthcare delivery system. Surgeons have implanted over
200,000 Mobi-C implants for cervical disc replacement at one level
or two contiguous levels since 2004. In 2013, Mobi-C became the
first cervical disc approved for one and two levels by the FDA and
remains the market-leading device for cervical disc replacement.
Unlike some competitive implants, the Mobi-C cervical disc
features low-profile endplates that do not require keel cuts or
additional hardware that could interfere with implants at an
adjacent level. This has made Mobi-C a compelling choice for
surgeons performing two-level disc replacement, and will likely
prove attractive in hybrid constructs with fusion at an adjacent
level.
Kee D. Kim, M.D., Professor and Chief of Spinal Neurosurgery at
the University of California, Davis, and one of the investigators
in the study, shared, “The FDA approval of the IDE application will
allow us to move forward with this important study. Good clinical
data is an important step in broadening the approved indications
for cervical disc replacement in hybrid constructs with fusion at
an adjacent level. I am delighted to be part of this groundbreaking
study, which may ultimately lead to more patients gaining access to
the most appropriate treatment.”
“The decision to move forward with the Mobi-C hybrid study
demonstrates our ongoing leadership and significant investment in
continuing to develop the cervical arthroplasty market,” said
Rebecca Whitney, Global President of ZimVie Spine. “We are
committed to and passionate about driving the expansion of this
market to provide a greater number of patients with the gift of
motion. We are pleased to be at the forefront of important clinical
studies to make motion preservation a reality for more
patients.”
The company intends to begin enrollment over the next several
months and conduct the IDE study with multiple surgeons at six
sites over the next five years.
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 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.
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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