Healthcare Industry News: Cardica
News Release - September 12, 2007
Cardica Receives European CE Mark for C-Port Flex A System for Use in Coronary Artery Bypass SurgeryFlex A System Facilitates Minimally Invasive and Robotic-Assisted Coronary Artery Bypass Surgery
REDWOOD CITY, Calif., Sept. 12 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) today announced that it has received European CE Mark (Conformite Europeenne) approval for the C-Port® Flex A Anastomosis System. The C-Port Flex A system is a variation of Cardica's C-Port® xA Distal Anastomosis System product line and further facilitates the automated anastomosis, or attachment of blood vessels and grafts, during less invasive coronary artery bypass graft (CABG) procedures. Recently, two independent groups of leading cardiothoracic surgeons in the U.S. performed minimally invasive, closed-chest bypass procedures using Cardica's C-Port Flex A Anastomosis System and Intuitive Surgical's da Vinci® Surgical System.
"We are pleased that the European authorities have approved the use of the Flex A. We continue to receive positive feedback from cardiothoracic surgeons in the U.S. who are using the C-Port Flex A to perform ground-breaking closed- chest and beating heart procedures," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "The C-Port Flex A is designed to enable surgeons to create compliant, reliable anastomoses in sternum-sparing bypass procedures, even in difficult to reach areas of the heart."
The C-Port Flex A system features several innovative modifications to Cardica's C-Port xA system, which is designed to enable automated, reliable and reproducible connections of blood vessels during CABG surgery. The C-Port Flex A system has a flexible, rather than rigid, shaft; is effective in creating compliant anastomoses in vessels as small as one millimeter in internal diameter; and, can be used in either on- or off-pump CABG procedures. Importantly, the flexible shaft allows surgeons to position the device to create a secure connection even in difficult to reach areas of the heart. The Flex A received 510(k) clearance from the U.S. Food and Drug Administration in March 2007.
"We believe the C-Port Flex A system brings us several steps closer to the possibility of performing truly minimally invasive cardiac surgery with significant benefits for the patient due to less trauma and a faster recovery time compared to a traditional open heart bypass procedure," stated Stefano Demertzis, M.D., Ph.D., senior cardiac surgeon at Cardiocentro Ticino in Lugano, Switzerland.
CABG Procedures and the Importance of Anastomoses
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. CABG procedures generally require approximately five anastomoses, often considered the most critical step of the surgery. The current predominant 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 the ability to perform 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® Distal Anastomosis Systems are marketed in Europe and the United States. The PAS-Port® 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 C-Port® Flex A Distal Anastomosis System, the features and benefits of the C-Port Flex A system, the growth potential for automated anastomosis systems 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 degree of market acceptance for our products as well as other risks detailed from time to time in Cardica's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2007. 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.
Da Vinci Surgical System is a registered trademark of Intuitive Surgical, Inc.
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