Healthcare Industry News: vascular closure
News Release - May 28, 2008
Renowned Leader and Educator in Robotic Cardiac Bypass Surgery Leverages Cardica's C-Port(R) Flex-A(R) Anastomosis System in His Practice and to Educate Cardiothoracic SurgeonsDr. Sudhir Srivastava Revolutionizing Minimally-Invasive Closed-Chest Bypass Surgery; Created Robotic Bypass Training Program Using Flex-A to Emphasize Reproducibility of Procedure and Decrease Learning Curve
REDWOOD CITY, Calif., May 28 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) today announced that internationally-renowned cardiothoracic surgeon Sudhir Srivastava, M.D., is innovating robot-assisted minimally-invasive cardiac bypass surgery with the use of the da Vinci® Surgical System and Cardica's C-Port® Flex-A® Anastomosis System to complete the anastomoses (connection of blood vessels). To date, Dr. Srivastava has completed 16 anastomoses in single and multivessel beating heart da Vinci revascularization procedures using the C-Port Flex-A system through small incisions in the chest cavity that create finger-size ports. Of 14 grafts studied, all were determined to be patent, or open, based on an analysis of follow-up angiography. Dr. Srivastava is director of robotic and minimally-invasive cardiac surgery at the University of Chicago Medical Center.
Dr. Srivastava pioneered both the da Vinci revascularization (DVR) and port-only coronary artery bypass (port-only CAB) surgical methods. These procedures require the creation of fingertip-size openings, or ports, that allow the surgeon to perform this breakthrough approach to minimally-invasive beating heart coronary bypass graft (CABG) surgery. These procedures are performed without the need to stop the heart or the use of a heart-lung machine. Dr. Srivastava has performed more of these procedures than any other surgeon in the world. Further, he has demonstrated these innovative techniques to other cardiothoracic surgeons in the United States and internationally. Prior to FDA clearance of the C-Port Flex-A system, Dr. Srivastava completed anastomoses using U-Clips, a technique that can be technically demanding.
"Having performed more than 300 closed-chest robotic beating heart bypass cases using other technologies, I can say that these manual techniques are dependent upon the skill and experience of the operating surgeon," said Dr. Srivastava. "The C-Port Flex-A system, on the other hand, helps enable cardiothoracic surgeons to successfully perform port-only CAB procedures with reproducible anastomoses and excellent early graft patency results."
He added, "The C-Port Flex-A system provides a consistent, mechanically-governed and repeatable automated attachment of the graft vessel during closed-chest bypass procedures and reduces the anastomosis time associated with port-only robotic surgery. Because the C-Port Flex-A system is enabling the next generation of robotic minimally-invasive cardiac surgery, I expect it will encourage broader adoption of minimally-invasive CABG procedures."
Dr. Srivastava also developed off-pump coronary artery bypass through a left lateral thoracotomy (thoraCAB), a procedure performed through a three- to five-inch incision in the side of the chest. This approach is frequently used for bypass surgery involving more than two vessel grafts. The port-only CAB and thoraCAB techniques are minimally-invasive procedures that eliminate the need to make a sternotomy which splits the breastbone (sternum). These techniques provide several patient benefits, including less scarring, faster recovery and reduced risk of complications. Dr. Srivastava's approach to multi-vessel closed-chest surgery was recently featured in USA Today on Wednesday April 30, 2008.
The C-Port System Advantage
Cardica's C-Port systems are designed to enable automated, reliable and reproducible connections of blood vessels during CABG surgery. Unlike most hand-sewn anastomoses, Cardica's C-Port systems enable a compliant anastomosis that can expand and contract with blood-flow. The C-Port Flex-A system is designed to deploy staples around the periphery of the anastomosis to help provide leak-proof sealing without the need for additional stitches at either end of the anastomosis. It can be used in either on- or off-pump CABG procedures. The C-Port Flex-A system has a flexible, rather than rigid, shaft and is designed to create compliant anastomoses in vessels as small as one millimeter in internal diameter. Importantly, the flexible shaft is designed to allow surgeons to position the device to create a secure connection even in difficult to reach areas of the heart.
Cardica is a leading provider of automated anastomosis systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with easy-to-use automated systems, Cardica's products provide 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 Europe and the United States. The PAS-Port® Proximal Anastomosis System is marketed in Europe and Japan, and Cardica has submitted a 510(k) premarket notification for clearance to market the PAS-Port system in the United States. Cardica also is developing additional devices with Cook Medical to facilitate vascular closure and other surgical procedures. For more information please go to http://www.cardica.com.
This press release contains forward-looking statements, including, without limitation, statements related to the potential expanded accessibility of closed-chest CABG procedures from future use of C-Port Flex-A systems and the potential of C-Port Flex-A systems in the field of cardiothoracic surgery. The word "expect" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Cardica's current expectations. Forward-looking statements involve risks and uncertainties. Cardica's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks associated with the long-term patency of graft vessels connected using the C-Port Flex-A system, market acceptance of Cardica's C-Port Flex-A system, manufacturing of the C-Port Flex-A system and its suppliers, and Cardica's sales, marketing and distribution strategy and capabilities. These and other risk factors are discussed under "Risk Factors" in Cardica's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2008. 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 the Company's reports filed with the U.S. Securities and Exchange Commission, available at http://www.sec.gov.
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