Anastomosis System Gets CE Approval for Coronary Artery Bypass Surgery
Cardica Inc. received the European CE Mark (Conformite Europeenne) for the C-Port Flex A Anastomosis System, a device that facilitates the automated anastomosis during less invasive coronary artery bypass graft (CABG) procedures.
The C-Port Flex A Anastomosis System is a variation of Cardica's C-Port xA Distal Anastomosis System product line. The C-Port Flex A system features several modifications to Cardica's C-Port xA system, which is designed to enable automated, reliable and reproducible connections of blood vessels during CABG surgery. The C-Port Flex A system has a flexible, rather than rigid, shaft; reportedly creates compliant anastomoses in vessels as small as one millimeter in internal diameter and, can be used in either on- or off-pump CABG procedures. The flexible shaft assists surgeons in positioning the device to create a secure connection even in difficult to reach areas of the heart.
The Flex A received 510(k) clearance from the U.S. Food and Drug Administration in March 2007.