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Cardica Announces Publication of Pivotal PAS-Port(R) Proximal Anastomosis System Clinical Trial Results
Date:7/22/2009

primary efficacy endpoint of non-inferiority in patency at nine-month follow up compared to hand-sewn anastomoses. In addition, of the 12 major adverse cardiac events (MACEs) reported that may possibly be related to target vessel revascularization, four (33%) may have been related to the PAS-Port system with eight (67%) potentially related to hand-sewn anastomoses. During the trial, four patients had a stroke. In all cases of stroke, an aortic clamp was used for construction of a hand-sewn anastomosis. The study also demonstrated that the PAS-Port system saves approximately five minutes of operating room time when compared to both side-biting and facilitating hand-sewn anastomoses.

"Used in the United States, Japan and Europe during thousands of CABG procedures to date, the PAS-Port system allows surgeons to perform rapid, safe and effective automated anastomoses either on- or off-pump, with very little manipulation of the aorta," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "Importantly, during the trial there were four cases of stroke, all of which occurred in patients where the aorta was clamped for hand-sewn anastomoses. By eliminating the need to clamp the aorta, we believe the PAS-Port system offers a significant benefit to bypass patients with no increased risk."

The PAS-Port Proximal Anastomosis System Advantage

The innovative design of the PAS-Port system allows a surgeon to load the bypass graft into the system and rapidly complete the anastomosis, typically in approximately two minutes, with little or no injury to the bypass graft vessel or the aorta. As of March 31, 2009, almost 14,000 PAS-Port systems had been sold in the United States, Japan and Europe, and according to Cardica's distributor, today this product is used in more than 20 percent of all proximal anastomoses performed using a vein bypass graft during CABG surgeries in Japan.

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SOURCE Cardica, Inc.
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