REDWOOD CITY, Calif., April 29 Cardica, Inc.(Nasdaq: CRDC) today announced that the PAS-Port(R) Proximal AnastomosisSystem achieved its primary endpoint in a large, prospective, randomizedpivotal clinical trial comparing graft vessel connections made using thePAS-Port system to conventional hand-sewn sutures during coronary arterybypass graft (CABG) procedures. Based on the positive data from the trial,Cardica submitted a 510(k) premarket notification to the U.S. Food and DrugAdministration (FDA) for the PAS-Port system. The PAS-Port system, which iscommercially available in Japan and Europe, creates a secure connection, oranastomosis, between a vein graft and the aorta, the main artery in the humanbody, during bypass procedures.
"The innovative design of the PAS-Port system allows surgeons toconsistently and reliably attach a graft vessel to the aorta, generally inabout two minutes," said Bernard A. Hausen, M.D., Ph.D., president and chiefexecutive officer of Cardica. "The PAS-Port system compliments our marketedC-Port system, and subject to receiving clearance of the PAS-Port system fromthe FDA, we will be able to provide surgeons with a complete suite of reliableautomated revascularization systems for use in CABG procedures."
Cardica conducted the 220-patient pivotal, prospective, randomized trialat 12 sites in the United States and Europe. The primary endpoint of the trialwas non-inferiority of the patency of the PAS-Port graft compared to thehand-sewn graft nine months following the CABG procedure. The PAS-Port systemmet the primary efficacy endpoint of non-inferiority in patency at nine-monthfollow up compared to hand-sewn anastomoses. Trial results will be presentedat future medical meetings.
In the trial, two venous bypass grafts were randomly selected in eachpatient to be connected to the aorta. The PAS-Port system was used for onegraft and the conventional hand-sewn technique for the other, for a total of440 randomized grafts. Patients were scheduled to receive a follow-upangiogram nine months after their index procedure to determine patency (ordegree of openness of the vein graft) for both the PAS-Port and controlgrafts. Over 90 percent of the patients received these angiograms. The trialdesign and endpoints reflect guidance received following the April 2005 FDApanel meeting regarding the PAS-Port system. The analysis and endpoints of theclinical trial results are consistent with the FDA approved protocol andstatistical analysis plan. During the pivotal trial, the customary FDAinspections validated Cardica's good clinical practices and data collectionmethods under FDA guidelines.
"I would like to thank the investigators and patients who participated inthis landmark trial for their excellent compliance in follow-upangiographies," continued Dr. Hausen. "We believe the robust data generated inthis trial help to further establish the long-term safety and efficacy of ourPAS-Port system."
The PAS-Port Proximal Anastomosis System Advantage
The innovative design of the PAS-Port system allows a surgeon to load thebypass graft into the system and rapidly complete the anastomosis, typicallyin approximately two minutes, with little or no injury to the bypass graftvessel or the aorta. Importantly, the PAS-Port system eliminates the need toclamp the aorta during CABG procedures. As of March 31, 2008, over 8,000PAS-Port systems had been sold in Japan and Europe, and according to Cardica'sdistributor, today this product is used in more than 20 percent of allproximal anastomoses performed using a vein bypass graft during CABG surgeriesin Japan.
About Cardica, Inc.
Cardica is a leading provider of automated anastomosis systems forcoronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutureswith easy-to-use automated systems, Cardica's products provide cardiovascularsurgeons with rapid, reliab