PLAINSBORO, N.J., Sept. 18, 2019 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART), a leading global medical technology company, today announced positive findings from its Cadence® Total Ankle System retrospective study. Tim Daniels, MD, FRCSC, Professor, University of Toronto and lead investigator for this study, reported that patients suffering from end-stage arthritis experienced improvements in quality of life, functional measures, and pain when treated with the Cadence prosthesis.
These findings were presented in an abstract during the annual American Orthopaedic Foot & Ankle Society (AOFAS) meeting held September 12-15 in Chicago, Illinois. The premier meeting for foot and ankle education, the AOFAS annual meeting features renowned speakers, the latest research and surgical advancements, and opportunities to connect with orthopaedic specialists from around the world.
In addition to this retrospective study, Integra also recently completed target enrollment ahead of schedule for two post-market studies – the U.S. and European Cadence Total Ankle System clinical studies. These studies are the first multi-center prospective studies ever conducted on the Cadence Total Ankle System.
The Cadence Total Ankle System was launched in 2016. These clinical studies are designed to understand performance and survivorship of the Cadence prosthesis in cemented (U.S. study) and uncemented (European study) surgical techniques and explore how Cadence addresses common clinical concerns such as loss of bone support and high complication rates associated with ankle arthroplasty.
Early feedback from the U.S. and European investigators is promising. “The physicians involved in the Cadence Total Ankle System post-market studies are excited that the implant has been performing very well,” said Dr. Daniels. “The undertaking of these studies signifies Integra LifeSciences’ commitment to scientific rigor and ensuring patient outcomes are being properly assessed and followed.”
About the Cadence U.S. and European Post-Market Studies
- The U.S. and European studies are evaluating two-year implant survivorship in patients receiving the Cadence Total Ankle System for primary ankle arthroplasty.
- Implant survivorship is further evaluated at five and 10 years post-operatively. Radiological, safety, clinical, and quality of life outcomes will be reported for all time points for both studies.
- For the U.S. Study, full enrollment of 131 patients at 12 participating study centers occurred between August 2017 and February 2019. Two-year follow-up data is expected to be published in 2021.
- For the European study, 61 patients were enrolled in six participating centers between September 2017 and June 2019.
Cadence® Total Ankle System is an 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).
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.
Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, Cadence®, Certas™, Codman®, CUSA®, DuraGen®, DuraSeal®, ICP Express®, Integra®, MediHoney®, MicroFrance®, PriMatrix®, Salto Talaris®, SurgiMend®, TCC-EZ®, Titan™ and VersaTru™. For the latest news and information about Integra and its brands, 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, 2018 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.