Integra LifeSciences Announces First Patient Enrolled in Cadence® Total Ankle System Post-Market Study
September 21 2017 - 05:00PM
Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading
global medical technology company, today announced the first
Cadence® Total Ankle System has been implanted by Dr. David
Pedowitz with the Rothman Institute in Philadelphia, Pennsylvania
in the Cadence Total Ankle System non-randomized, prospective,
multi-center post-market study.
“While this patient represents only one of many who have already
benefited from the Cadence Total Ankle System, she is the first of
my patients who will be a part of this important study, documenting
the unique benefits of this new system in terms of ease of use,
patient satisfaction, and survivability,” said Dr. David
Pedowitz.
The primary objective of the study is to evaluate 2-year implant
survivorship in subjects who received the Cadence Total Ankle
System for primary ankle arthroplasty. Implant survivorship will
further be evaluated at 5 and 10 years post-operatively. All
patients in the study will receive the Cadence Total Ankle
System.
About CadenceCadence Total Ankle System, is a
new ankle prosthesis developed in partnership with four world
leading foot and ankle surgeons – Dr. Tim Daniels (University of
Toronto, Toronto, Canada), Dr. David Pedowitz (Rothman Institute,
Philadelphia, Pennsylvania), Dr. Selene Parekh (Duke University,
Durham, North Carolina) and Dr. Christopher Hyer (Orthopedic Foot
& Ankle Center, Westerville, Ohio). To date, more than 350
Cadence total ankle procedures have been successfully performed in
seven countries.
The Cadence system has garnered positive feedback among its
users for advancements in implant and instrument design, along with
a streamlined surgical technique. Cadence incorporates several
features to accommodate various patient anatomies, reduce potential
clinical complications, and address common challenges associated
with ankle arthroplasty procedures. Key implant features
include:
- Side-specific, anatomical tibial components, designed to avoid
fibular impingement.
- Side-specific, anatomical talar components, designed to
minimize resected talar bone and to preserve vascularity in the
ankle.
- Bearing insert components manufactured from a highly
crosslinked ultra-high molecular weight polyethylene (HXL UHMWPE)
for improved wear characteristics, and patent pending-biased
sagittal profile options to address patients with subluxed talar
anatomy.
About Integra Integra LifeSciences is dedicated
to limiting uncertainty for clinicians, so they can concentrate on
providing the best patient care. Integra offers innovative
solutions, including leading plastic and regenerative technologies,
in specialty surgical solutions, orthopedics and tissue
technologies. For more information, please visit
www.integralife.com.
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include, but are not limited to,
statements concerning the products and services provided by
Integra. Such forward looking statements involve risks and
uncertainties that could cause actual results to differ materially
from predicted or expected results. Among other things, the
willingness of surgical professionals to use Integra products may
affect the prospects for their use in surgical procedures. In
addition, the economic, competitive, governmental, technological
and other factors, identified under the heading "Risk Factors"
included in Item IA of Integra's Annual Report on Form 10-K for the
year ended December 31, 2016 and information contained in
subsequent filings with the Securities and Exchange Commission
could affect actual results.
CONTACT: Integra LifeSciences Holdings Corporation
Investor Relations Contact:
Michael Beaulieu609-750-2827michael.beaulieu@integralife.com
Media Contact:
Laurene Isip609-750-7984Laurene.isip@integralife.com
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