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Angiology
Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypass Surgery
May 18th, 2008
Cardica, Inc. (NASDAQ:CRDC) announced that the PAS-Port(R) Proximal Anastomosis System achieved its primary endpoint in a large, prospective, randomized pivotal clinical trial comparing graft vessel connections made using the PAS-Port system to conventional hand-sewn sutures during coronary artery bypass graft (CABG) procedures. Based on the positive data from the trial, Cardica submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the PAS-Port system. The PAS-Port system, which is commercially available in Japan and Europe, creates a secure connection, or anastomosis, between a vein graft and the aorta, the main artery in the human body, during...
Source: Medical Letter on the CDC & FDA (2008-05-18)
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