Cardica Reports Positive Top-Line Results And Submits 510(k) For PAS-Port(R) Proximal Anastomosis System In Cardiac Bypass Surgery

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices;  Clinical Trials / Drug Trials
Article Date: 30 Apr 2008 - 0:00 PDT

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Cardica, Inc. (Nasdaq: CRDC) 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 future medical meetings.

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.

"I would like to thank the investigators and patients who participated in this landmark trial for their excellent compliance in follow-up angiographies," continued Dr. Hausen. "We believe the robust data generated in this trial help to further establish the long-term safety and efficacy of our PAS-Port system."

The PAS Port Proximal Anastomosis System Advantage

The innovative design of the PAS-Port system allows a surgeon to load the bypass graft into the system and rapidly complete the anastomosis, typically in approximately two minutes, with little or no injury to the bypass graft vessel or the aorta. Importantly, the PAS-Port system eliminates the need to clamp the aorta during CABG procedures. As of March 31, 2008, over 8,000 PAS-Port systems had been sold in Japan and Europe, and according to Cardica's distributor, today this product is used in more than 20 percent of all proximal anastomoses performed using a vein bypass graft during CABG surgeries in Japan.

About Cardica, Inc.

Cardica is a leading provider of automated anastomosis systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica's products provide cardiovascular surgeons with rapid, reliable and consistently reproducible anastomoses, or connections of blood vessels, often considered the most critical aspect of the CABG procedure. Cardica's C-Port(R) Distal Anastomosis Systems are marketed in Europe and the United States. The PAS-Port(R) Proximal Anastomosis System is marketed in Europe and Japan, and Cardica has submitted a 510(k) premarket notification for clearance to market the PAS-Port system in the United States. Cardica also is developing additional devices with Cook Medical to facilitate vascular closure and other surgical procedures.

Forward Looking Statements

This press release contains "forward-looking" statements, including statements relating to the potential commercial availability of Cardica's PAS-Port system. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words "will" and "believe" or similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Cardica's results to differ materially from those indicated by these forward-looking statements, including risks associated with whether and when Cardica receives FDA clearance for the PAS-Port system, and the lack of long-term data regarding the safety and efficacy of Cardica's products, as well as other risks detailed from time to time in Cardica's SEC reports, including its Annual Report on Form 10-Q for the fiscal quarter ended December 31, 2007. Cardica does not undertake any obligation to update forward-looking statements. You are encouraged to read Cardica's reports filed with the U.S. Securities and Exchange Commission, available at http://www.sec.gov.

Cardica, Inc.
http://www.cardica.com