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news.Cardica has announced that the PAS-Port 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 procedures.
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Based on the positive data from the trial, Cardica has submitted a 510(k) premarket notification to the FDA for the PAS-Port system. The PAS-Port system creates a secure connection, or anastomosis, between a vein graft and the aorta, the main artery in the human body, during bypass procedures.
Cardica conducted the 220-patient pivotal, prospective, randomized trial at 12 sites in the US 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 coronary artery bypass graft (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.
Bernard Hausen, president and CEO of Cardica, said: “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.”