Cardica receives 510(k) clearance for PAS-Port anastomosis system

Executive Summary

The US FDA has granted 510(k) clearance for the PAS-Port proximal anastomosis system for use in cardiac bypass surgery. The PAS-Port system, developed by Redwood City, California-based firm Cardica, connects a grafted vein with the aorta. The system allows an automated proximal anastomosis to be conducted without the need to clamp and manipulate the aorta, typically within one minute. Eliminating this clamp reduces the risk of release of small blood clots and other debris, thus reducing the chances of stroke and other neurological complications. The approval caused Cardica's share price to rise 25.8%, reaching $10.05; a second rise may be on the cards when the device is launched "in the next several weeks".