Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypa...( REDWOOD CITY Calif. April 29 /- C...),Health

REDWOOD CITY, Calif., April 29 /PRNewswire-FirstCall/ -- Cardica, Inc. (Nasdaq: CRDC) today 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 bypass procedures.

"The innovative design of the PAS-Port system allows surgeons to consistently and reliably attach a graft vessel to the aorta, generally in about two minutes," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "The PAS-Port system compliments our marketed C-Port system, and subject to receiving clearance of the PAS-Port system from the FDA, we will be able to provide surgeons with a complete suite of reliable automated revascularization systems for use in CABG procedures."

Cardica conducted the 220-patient pivotal, prospective, randomized trial at 12 sites in the United States and Europe. The primary endpoint of the trial was non-inferiority of the patency of the PAS-Port graft compared to the hand-sewn graft nine months following the CABG procedure. The PAS-Port system met the primary efficacy endpoint of non-inferiority in patency at nine-month follow up compared to hand-sewn anastomoses. Trial results will be presented at fu
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