Healthcare Industry News: anastomosis
News Release - March 28, 2007
Cardica Completes Enrollment for PAS-Port(R) System Clinical Trial for Use in Bypass SurgeryREDWOOD CITY, Calif., March 28 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) today announced it completed enrollment of approximately 220 patients in a pivotal clinical trial to evaluate the safety and efficacy of its PAS-PortŪ Proximal anastomosis System during coronary artery bypass graft (CABG) surgery. 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 PAS-Port system's automated reliability and precise engineering facilitate rapid, consistent anastomoses during both on and off-pump bypass surgeries," said John Puskas, M.D., Chief of Cardiac Surgery, Emory Crawford Long Hospital, Associate Chief of Cardiothoracic Surgery, Emory University, and principal investigator of the trial. "By eliminating the need to clamp the aorta, this device may reduce the risk of neurological complications and mortality associated with beating heart bypass procedures and may ultimately play a key role in advancing less invasive cardiac surgery."
The pivotal, prospective, randomized trial is being conducted in the United States under an Investigational Device Exemption. Approximately 220 patients have been enrolled at 14 sites in the United States and Europe. Two venous bypass grafts were randomly selected in each patient to be connected to the aorta using either the PAS-Port device or the conventional hand-sewn technique. Patients will receive a follow-up angiogram nine months after their procedure to determine patency (or degree of openness of the vein graft) of both PAS-Port and control grafts. If the results of this trial are favorable, the company plans to submit a 510(k) application for the PAS-Port system to the U.S. Food and Drug Administration in early 2008.
"The completion of enrollment in this pivotal trial signifies a major step forward both for Cardica and for the field of minimally invasive cardiac surgery," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc.
The innovative design of the PAS-Port system allows the surgeon to load the bypass graft and rapidly complete the anastomosis, typically in approximately two minutes, with little or no injury to the bypass graft vessel or the aorta. As of December 31, 2006, over 4,800 PAS-Port systems had been sold in Japan and Europe, and 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.
In previous clinical trials conducted in Europe, the 6 month patency rate with anastomoses completed with the PAS-Port system ranged from approximately 87 to 98 percent compared to an average of 84 percent reported in the literature for traditional hand-sewn anastomoses at the same time point.
About CABG Surgery
Coronary heart disease causes one out of every five deaths in the United States, making it the single largest killer of Americans. While other treatment alternatives exist, studies show that CABG surgery achieves the best long-term patient outcome for coronary heart disease as measured by survival rate and need for re-intervention. In 2007, an estimated 220,000 to 250,000 CABG procedures will be performed in the United States, each requiring approximately five anastomoses, often considered the most critical step of the surgery. The current method of performing an anastomosis in a CABG procedure utilizes technically demanding, tedious and time-consuming hand sewn sutures to connect a bypass graft vessel to the aorta and to small diameter coronary vessels. Clamping of the aorta when creating a conventional hand-sewn anastomosis has been associated with neurological complications.
About Cardica, Inc.
Cardica designs and manufactures automated anastomosis systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica provides 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-PortŪ Distal anastomosis Systems are marketed in Europe and the United States. The PAS-PortŪ Proximal anastomosis System is marketed in Europe and Japan and is being evaluated in a pivotal trial in the United States and Europe. Cardica also is developing additional devices to facilitate vascular and other surgical procedures. Go to http://www.cardica.com for more information.
Forward Looking Statements
This press release contains "forward-looking" statements, including statements relating to the ongoing clinical trial, efficacy and potential application for U.S. regulatory approval of the PAS-Port Proximal anastomosis System and other matters. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words "believe," "plan," "expect," "estimate," "intend" and "will" 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 the timing and success of clinical trial using the PAS- Port Proximal anastomosis System, as well as other risks detailed from time to time in Cardica's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended December 31, 2006. Cardica does not undertake any obligation to update forward-looking statements. You are encouraged to read the Company's reports filed with the U.S. Securities and Exchange Commission, available at http://www.sec.gov.
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