April 30, 2008 - The PAS-Port Proximal Anastomosis System achieved its primary endpoint in a large, prospective, randomized pivotal clinical trial, and based these results, Cardica has submitted a 510(k) premarket notification to the FDA for the PAS-Port system.
The trial compared graft vessel connections made using the PAS-Port system to conventional hand-sewn sutures during coronary artery bypass graft (CABG) procedures. 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.
Cardica conducted the 220-patient pivotal, prospective, randomized trial at 12 sites in the U.S. 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 noninferiority in patency at nine-month follow up compared to hand-sewn anastomoses.
In the trial, two venous bypass grafts were randomly selected in each patient to be connected to the aorta. The PAS-Port system was used for one graft and the conventional hand-sewn technique for the other, for a total of 440 randomized grafts. Patients were scheduled to receive a follow-up angiogram nine months after their index procedure to determine patency (or degree of openness of the vein graft) for both the PAS-Port and control grafts. Over 90 percent of the patients received these angiograms. The trial design and endpoints reflect guidance received following the April 2005 FDA panel meeting regarding the PAS-Port system. The analysis and endpoints of the clinical trial results are consistent with the FDA approved protocol and statistical analysis plan. During the pivotal trial, the customary FDA inspections validated Cardica's good clinical practices and data collection methods under FDA guidelines.
For more information: www.cardica.com