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.