To satisfy the requirements set forth in post-market surveillance orders issued by the US FDA to Cardica, Inc., the following outcomes will be evaluated:
1. Acute, midterm, and one-year graft failure rates for coronary revascularization using the C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System, and C-Port® XCHANGE™ Distal Anastomosis System when in general use in the United States compared to hand-sewn anastomoses.
2. Technical failure rates when attempting to complete an anastomosis using the C-Port xA, FlexA, and XCHANGE Distal Anastomosis Systems.
3. The technical success rate of hand-sewn anastomoses following technical failures of the C-Port devices and the hand-sewn graft patency rates and clinical sequelae at one year.
