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news.Cardica, a provider of automated anastomosis systems for coronary artery bypass graft surgery, has announced that the FDA has granted the company 510(k) clearance to market its Pas-Port proximal anastomosis system for use in cardiac bypass surgery.
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The Pas-Port system is said to create a secure connection, or anastomosis, between a vein graft and the aorta, the main artery in the human body, during coronary artery bypass grafting (CABG) procedures. Currently available in Japan and Europe, the PAS-Port system is now commercially available by Cardica in the US.
Cardica has previously conducted a 220-patient, prospective, pivotal, randomized trial of Pas-Port at 12 sites in the US and Europe. The trial compared venous bypass graft vessel connections to the aorta made using the Pas-Port system versus those made using conventional hand-sewn sutures. Results showed that the study met its primary endpoint of non-inferiority to hand-sewn anastomoses, as well as all other primary and secondary endpoints.
Bernard Hausen, president and CEO of Cardica, said: “With the introduction of the PAS-Port system in the US, cardiothoracic surgeons are now provided with a complete package of reliable, automated revascularization systems for use in CABG procedures.”