Cardica, Inc.'s C-Port(R) xA Anastamosis System Receives European CE Mark Approval
"We believe that the C-Port xA system offers surgeons automated, predictable and compliant anastomoses. The expanded arterial indication will allow the system to be used in more grafting procedures and enable the development of closed chest CABG procedures," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "CE Mark approval represents another important step in our strategy to transform bypass surgery by providing the highest quality, automated anastomosis systems in the United States, Europe and Japan. European approval paves the way for a controlled introduction and training of surgeons on the C-Port xA system in this market."
The C-Port xA Distal Anastomosis System Advantage
The C-Port xA system features several innovative modifications to Cardica's C-Port product offering, including a change from a spring-driven to a CO2-driven stapling mechanism; improved access to the coronary artery and reduction of target site preparation; optimization of the staple configuration; and incorporation of vessel clamps for ease of loading the graft vessel for anastomosis. The C-Port xA system is designed to deploy staples around the periphery of the anastomosis to help ensure leak-proof sealing. Unlike most hand-sewn anastomoses, the C-Port system enables a compliant anastomosis that can expand and contract with blood-flow.
Cardica has submitted the C-Port xA system for 510(k) clearance with the U.S. Food and Drug Administration.
The Role of Anastomoses in CABG Procedures
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-Port® Distal Anastomosis System is marketed in Europe and the United States. The PAS-Port® 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 efficacy, European launch future use and potential U.S. regulatory approval of Cardica's C-Port xA Distal 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 clinical performance, market acceptance and U.S. regulatory approval of Cardica's C-Port xA Distal 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.
Source: Cardica, Inc.