Healthcare Industry News: PAS-Port
News Release - November 20, 2006
Cardica Receives 510(k) Clearance for C-Port xA(TM) Distal Anastomosis System for Use in Coronary Artery Bypass SurgeryREDWOOD CITY, Calif., Nov. 20 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its C-Port xA(TM) Distal Anastomosis System in the U.S. The C-Port xA system is the next generation of Cardica's C-Port system, and automates the creation of anastomoses, or attachments of blood vessels and grafts, such as those in coronary artery bypass graft (CABG) surgeries.
"With the C-Port xA system, surgeons can perform completely automated, predictable, and compliant anastomoses in a broad range of CABG procedures. No additional stitches at the anastomosis site are required," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "We believe that this clearance will help drive adoption of our automated anastomosis system, particularly in beating heart surgeries where the C-Port xA system's ease-of-use, reliability and enhanced features are especially useful."
The C-Port xA Distal Anastomosis System Advantage
The C-Port xA system features several innovative modifications to Cardica's C-Port product offering. The C-Port xA system is designed to deploy staples around the periphery of the anastomosis to help provide leak-proof sealing. Other features include 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. Unlike most hand-sewn anastomoses, the C-Port Xa system enables a compliant anastomosis that can expand and contract with blood-flow.
The C-Port xA system received the CE Mark in July 2006 and is currently marketed in Europe.
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 Systems are marketed in the United States and Europe. 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 www.cardica.com for more information.
Forward Looking Statements
This press release contains "forward-looking" statements, including statements relating to the potential adoption and advantages of the C-Port xA Distal Anastomosis System. 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 training of surgeons and market acceptance of the C-Port xA Distal Anastomosis System; Cardica's limited experience as a company in the sales and marketing of its products; and manufacturing of the 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 September 30, 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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