Cardica Receives 510(k) clearance for CABG system
The FDA has granted Cardica 510(k) clearance to market its PAS-Port proximal anastomosis system for use in CABG.
The PAS-Port system creates a secure connection, or anastomosis, between a vein graft and the aorta during CABG procedures, according to the Redwood City, Calif.-based company. Currently available in Japan and Europe, where it has been used more than 8,800 times, the PAS-Port system is now commercially available by Cardica in the U.S.
Cardica said that its PAS-Port system allows a surgeon to complete an automated proximal anastomosis without the need to clamp and manipulate the aorta, which could reduce the risk of particle release and ensuing neurocognitive events.
The PAS-Port system creates a secure connection, or anastomosis, between a vein graft and the aorta during CABG procedures, according to the Redwood City, Calif.-based company. Currently available in Japan and Europe, where it has been used more than 8,800 times, the PAS-Port system is now commercially available by Cardica in the U.S.
Cardica said that its PAS-Port system allows a surgeon to complete an automated proximal anastomosis without the need to clamp and manipulate the aorta, which could reduce the risk of particle release and ensuing neurocognitive events.