Healthcare Industry News: anastomosis
News Release - June 27, 2006
Cardica Begins Pivotal Trial for PAS-Port(R) Proximal Anastomosis System for Use in Bypass SurgeryREDWOOD CITY, Calif., June 27 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) today announced the start of a pivotal clinical trial in the United States and Europe to evaluate the safety and efficacy of its PAS-PortŪ Proximal anastomosis System during coronary artery bypass graft (CABG) surgery. The trial is being conducted in the United States under an Investigational Device Exemption.
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.
"This trial is intended to demonstrate that the PAS-Port system will provide a proximal anastomosis that is at least as good as hand-sewn sutures," said John D. Puskas, M.D., Chief of Cardiac Surgery, Emory Crawford Long Hospital, and Associate Chief of Cardiothoracic Surgery, Emory University, and principal investigator of the trial. "The PAS-Port system's ability to facilitate beating heart bypass surgery may reduce the risk of neurological complications and mortality associated with clamping the aorta during beating heart procedures."
The pivotal, prospective, randomized trial will enroll approximately 220 patients at ten sites in the United States and Europe. Patients enrolled in the trial will receive both a PAS-Port automated anastomosis and a hand-sewn anastomosis as a control for a total of 440 evaluable anastomoses in the study. All patients will receive a follow-up angiogram nine months after the 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 by the end of 2007.
"The PAS-Port system appears to be the most technically advanced, highest- quality, consistently reliable device developed so far to automate and facilitate anastomoses during stopped and beating heart bypass procedures," said Mark W. Connolly, M.D., Cathedral Advanced Cardiothoracic Surgeons, LLC, Saint Michael's Medical Center, Newark, New Jersey, and an investigator in the trial. "The PAS-Port could prove to be a major step forward in facilitating mechanical anastomoses. Once we were trained, the anastomosis took a little over two minutes, including loading time." The cardiac surgery team of Drs. Connolly and Tyrone J. Krause, M.D. performed the first procedure utilizing the PAS-Port system in this trial.
Over 3,500 PAS-Port systems have been sold in Japan and Europe. This product is currently used in more than 10 percent of all coronary revascularization procedures performed in Japan. In previous clinical trials 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 2006, an estimated 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.
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 System is marketed in Europe and the United States. The PAS-PortŪ Proximal anastomosis System is marketed in Europe and Japan. Cardica also is developing additional devices to facilitate vascular and other surgical procedures. Go to 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 the 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 March 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 www.sec.gov.
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