Integra LifeSciences Announces First Patient Enrolled in Cadence® Total Ankle System Post-Market Study
PLAINSBORO, N.J., Sept. 21, 2017 (GLOBE NEWSWIRE) -- 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.
Cadence 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.
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.
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