Zimmer Release: Synovasure PJI Test Earns Certification To Clear Way For European Sales
WARSAW, Ind., Nov. 19, 2014 /PRNewswire/ -- Zimmer today announced Synovasure PJI Alpha Defensin Test for Periprosthetic Joint Infection, the first and only test specifically designed for the diagnosis of Periprosthetic Joint Infection (PJI), is now eligible for sale in several European countries after earning key overseas certification this month.
Synovasure received its Certificate of CE (IVD) Notification and European Authorized Representative (EAR) certificate, according to European Council directives. With both certificates in place, Zimmer, in conjunction with its manufacturing partner CD Diagnostics, is now cleared to launch the Synovasure PJI Test to an initial Tier 1 group of countries, including Germany, Italy, Netherlands, Spain, Switzerland and the UK.
"The Synovasure PJI Test already delivers unparalleled accuracy, performance and ease of use in the U.S., and we are very excited to make the same technology available to doctors and patients in Europe," said Matt Monaghan, Senior Vice President of Global Hips and Reconstructive Research for Zimmer. "By being able to accurately determine PJI within 10 minutes, the Synovasure PJI Test brings a new level of diagnostics to the European market."
With 97 percent sensitivity, 96 percent specificity and test results available within 10 minutes, the Synovasure PJI Test will provide surgeons in Europe critical information to enable earlier and more accurate diagnosis of PJI.
The Synovasure PJI Test is expected to officially launch for use in the Tier 1 group of countries in Europe this month. For more information, visit synovasure.zimmer.com/eu.
About the Company
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopaedic reconstructive, spinal and trauma devices, dental implants, and related surgical products. Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer's 2013 sales were approximately $4.6 billion. The Company is supported by the efforts of more than 9,000 employees worldwide. More information about Zimmer is available at www.zimmer.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon the current beliefs and expectations of Zimmer's management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties include, but are not limited to: future test results or patient experiences being inconsistent with test findings to date; actions of regulatory bodies or other governmental authorities; changes in laws and regulations; competitive developments; and other risks and uncertainties described in Zimmer's periodic reports filed with the U.S. Securities and Exchange Commission. Zimmer disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in Zimmer's periodic reports. Readers of this communication are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.
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SOURCE Zimmer Holdings, Inc.