Vivasure Medical Scores CE Mark for Closure Device
Vivasure Medical has obtained the CE mark for its percutaneous vascular closure device for large-bore femoral arteriotomies.
According to Vivasure, the device is fully bioabsorbable, sutureless and fully synthetic. It includes a delivery system and single-use, patch-like device.
Clinical studies with patients in four EU countries showed achieved 97 percent device technical success with no major device-related complications.
The device is currently not approved in the U.S. — Michael Cipriano