Integra LifeSciences Announces the Approval of DuraGen® in Japan
PLAINSBORO, N.J. and TOKYO, March 14, 2019 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART), a global leader in medical technology, announces the recent approval of DuraGen® Dural Regeneration Matrix in Japan. DuraGen is the first and only non-autologous collagen xenograft approved for use as a dural substitute in Japan.
“DuraGen’s proven clinical safety and efficacy at preventing CSF leaks, infections, and foreign body reactions, have benefited more than two million patients for more than 20 years,” said Mike McBreen, senior vice president and president, International. “We are confident that DuraGen will similarly impact practice in Japan, helping surgeons provide the benefits of improved dural closure to their patients.”
First introduced in the United States in 1999, Integra’s DuraGen products are the most studied and proven dural xenografts worldwide. In 10 published clinical studies involving more than 1,400 patients, DuraGen’s Ultra Pure Collagen™ and engineered pore structure have been shown to create an optimized environment for platelet aggregation and rapid fibrin clot formation to help prevent CSF leaks and other complications. DuraGen is expected to be commercially available in Japan in the third quarter of 2019.
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.
CONTACT: Integra LifeSciences Holdings Corporation
Senior Vice President, Strategy, Treasury and Investor Relations
+33 437 475 900
Integra Japan 株式会社