Newly Cleared Cardica Device Connects Blood Vessels in CABG Surgeries
Cardica Inc. has announced that it has received FDA 510(k) clearance to market its C-Port Flex A Anastomosis System in the U.S.
The Flex A is a variation of Cardica's C-Port xA Distal Anastomosis System product line and further facilitates the automated anastomosis, or attachment of blood vessels and grafts, during less invasive coronary artery bypass graft (CABG) procedures.
"We are excited about the clearance of the C-Port Flex A system because it gives surgeons improved maneuverability and brings us several steps closer to the possibility of performing truly minimally invasive cardiac surgery," stated Valavanur Subramanian, M.D., director of surgery for Lenox Hill Heart and Vascular Institute of New York. "This device enables surgeons to consistently and reliably create automated anastomoses in areas of the heart that are difficult to reach, and particularly difficult to hand-suture, especially during beating heart procedures."
The C-Port Flex A system features several innovative modifications to Cardica's C-Port xA product offering 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; is effective in creating compliant anastomoses in vessels as small as one millimeter in internal diameter; and, it can be used in either on- or off-pump CABG procedures. Importantly, the flexible shaft allows surgeons to position the device to create a secure connection even in the most difficult to reach areas of the heart.
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