REDWOOD CITY, Calif., Oct. 25 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced the publication of a 5-year study demonstrating the safety and efficacy of its PAS-Port® Proximal Anastomosis System. The study, published in the November 2010 issue of the Annals of Thoracic Surgery, evaluated the frequency of major adverse events five years after undergoing coronary artery bypass graft (CABG) surgery using the PAS-Port system and patency (openness) of the grafted vessels six months following the procedure.
Results of the study show that the PAS-Port system produced a patent connection in 88% of the 117 vein grafts attached to the aorta using the PAS-Port system six months after surgery, as determined by angiography. This compares to published studies showing approximately 84.1% of grafts patent at six months following bypass procedures completed using hand-sewn sutures. Importantly, five years following bypass procedures using the PAS-Port system, 80% of the 117 patients were free of adverse events including death, stroke, myocardial infarction and target vessel revascularizations. This compares to approximately 74.3% seen in published literature when using hand-sewn sutures. The study was conducted by Dr. Stefanos Demertzis, senior cardiac surgeon at Cardiocentro Ticino in Lugano, Switzerland and associate professor at the University of Bern.
"The PAS-Port system allows me to attach a vein to the aorta without using a clamp, as the clamp has been shown to be the major cause of strokes in bypass surgery," said Dr. Demertzis. "The attachment of the vessel can be done significantly faster with the PAS-Port system than using the conventional hand-sewn method. Further, this study reproduces the patency rates demonstrated in the EPIC trial, where patency was 85% at nine months, and clearly shows that the use of anastomotic connectors such as the PAS-Port device produce equivalent patency rates and reduce long-term complications. In short, it is my opinion that the PAS-Port system is a safe and effective product to potentially reduce the incidence of strokes during coronary bypass surgery."
The most-used method in CABG surgery of connecting a bypass graft vessel to the aorta, the main artery in the human body, often requires that the aorta be clamped and utilizes time-consuming hand-sewn sutures. When the clamp is released, tiny blood clots or particles from the aortic wall can be released, which can then travel to the brain and cause stroke and other neurologic complications. The PAS-Port system allows a surgeon to complete an automated proximal anastomosis without the need to clamp the aorta. Eliminating the clamp may greatly reduce the risk of particle release and ensuing neurocognitive events.
The PAS-Port system received 510(k) clearance from the U.S. Food and Drug Administration in September 2008 and the CE Mark in 2004. 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. As of June 30, 2010, almost 20,000 PAS-Port systems had been sold in the United States, Japan and Europe.
"Dr. Demertzis has been using the PAS-Port system routinely in his practice since 2004, and this publication is the first long-term study to validate the safety, efficacy and reduction of long-term complications by using the PAS-Port system," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "We thank Dr. Demertzis for his dedication to advancing the field of cardiac surgery and commend him on the excellent cardiac care he provides for his patients."
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and endoscopic surgical procedures. Cardica's technology portfolio is intended to minimize operating time and enable minimally-invasive and robot-assisted surgeries. Cardica manufactures and markets its automated anastomosis systems, the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System, for CABG surgery and has shipped over 30,000 units throughout the world. In addition, Cardica is developing the Cardica Microcutter ES8, a true multi-fire endoscopic stapling device designed to be used in a variety of procedures, including bariatric, thoracic and general surgery. Information about the microcutter is provided for planning purposes. The microcutter requires a 510(k) review and is not yet commercially available.
This press release contains "forward-looking" statements, including all statements regarding the potential benefits of using 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 "may," "potentially" and 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 that patient outcomes in one study may not be reflective of general patient outcomes, that longer term safety and efficacy data may not be as favorable, and that Cardica's current and any future products may never gain any significant degree of market acceptance, as well as other risks detailed from time to time in Cardica's reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended June 30, 2010. Cardica expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. You are encouraged to read Cardica's reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.
SOURCE Cardica, Inc.