Healthcare Industry News: PAS-Port
News Release - May 9, 2007
The Wisconsin Heart Hospital First in U.S. to Use Newly FDA-Cleared Device to Perform Blood Vessel Graft During Bypass SurgeryDr. Husam H. Balkhy Performed Live Case Using C-Port and C-Port Flex A Devices at Advanced Cardiac Techniques in Surgery (ACTS) 2007
WAUWATOSA, Wis., and REDWOOD CITY, Calif., May 9 (HSMN NewsFeed) -- A nationally-renowned cardiothoracic surgeon at The Wisconsin Heart Hospital, Husam H. Balkhy, M.D., was the first in the United States to use the C-Port® Flex A Anastomosis System, a fully-automated, flexible shaft device developed by Cardica, Inc., to attach a blood vessel graft during coronary artery bypass surgery.
"By using the C-Port Flex A system, we were able to attach the vessel graft effectively in an area that is typically very difficult to reach. This patient is alive today because of the successful surgery to restore his blood flow," said Husam H. Balkhy M.D., Chairman of the Department of Cardiothoracic Surgery at The Wisconsin Heart Hospital, in his comments about the first case in the U.S. using the C-Port Flex A system the week before the Advanced Cardiac Techniques in Surgery (ACTS) 2007 meeting. "The Wisconsin Heart Hospital continues to be on the cutting edge of cardiothoracic surgery technology, adding the most technically-sophisticated, safe and effective devices like the C-Port Flex A to improve patient outcomes and enable less invasive cardiac surgery."
Dr. Balkhy and his team at The Wisconsin Heart Hospital connected the left internal mammary artery (LIMA), an ideal choice as it remains open for a significantly longer period following bypass surgery, to the left anterior descending (LAD) artery during the procedure on a 55 year old male patient who was an extremely high-risk candidate for coronary bypass surgery. This patient is doing well today. His outcome was facilitated by the use of the C- Port Flex A system, in an off pump coronary bypass procedure, enabling minimal manipulation of his very weak heart.
In addition to the case at the Wisconsin Heart Hospital, Dr. Balkhy successfully performed one of six live cases in New York during the ACTS 2007 Meeting held May 3 and 4, using both the C-Port® Distal Anastomosis System and the C-Port Flex A system to attach the vessel grafts during bypass surgery. During the live case that was conducted at the conference attended by approximately 400 participants, Dr. Balkhy performed a three vessel off pump coronary bypass procedure, using the C-Port Flex A system for two of the bypasses (including the LIMA) and the C-Port xA system for the third bypass. The case was transmitted live from the Lenox Hill Hospital operating room to the audience via High Definition transmission.
Coronary artery bypass surgery is performed to restore blood flow through the vessels which supply blood to the heart. The surgery is performed by taking a small part of a blood vessel from another part of the body, most often a vein from the leg or an internal mammary artery from the chest area, and surgically attaching it across an area of severe narrowing or blockage, thus bypassing the blockage. The blood is rerouted through the healthy vessel and blood flow is restored to the heart muscle.
The C-Port Flex A System, developed by Cardica, Inc., attaches the end of a bypass vessel graft to a coronary artery. This connection, called an anastomosis, is often considered the most critical step of bypass surgery. The average bypass surgery requires three grafts. The current method of performing an anastomosis takes approximately ten to 15 minutes per anastomosis and uses technically demanding, tedious and time-consuming hand- sewn sutures to connect a blood vessel to the aorta and to small diameter coronary vessels. With the C-Port Flex A's flexible shaft, surgeons can position the device to create a secure connection even in the most difficult to reach areas of the heart. The connection is complete typically in less than two minutes and requires no additional hand-sewn sutures for the anastomosis. This device received 510(k) clearance from the U.S. Food and Drug Administration in April 2007.
About The Wisconsin Heart Hospital
Located in Wauwatosa, Wisconsin, the Wisconsin Heart Hospital, a member of Wheaton Franciscan Healthcare, was the vision of a group of cardiac, vascular and specialty physicians who wanted to treat broad-based diseases that affect cardiac and vascular systems. They began with a unique premise -- they wanted to help shape the future of cardiovascular care through locating innovative workflow, patient care, diagnostics and imaging technologies under one roof.
The only cardiovascular specialty hospital and first accredited chest pain center in the Milwaukee area, the 60-bed hospital was designed for the complexities of heart and vascular care. Its services include diagnostic and interventional cardiac catheterization and peripheral vascular procedures, electrophysiology, surgical services, diagnostic imaging, emergency services and wellness and preventive medicine programs.
As a result of its focus on patient service, TWHH has earned five national awards for patient perception of quality and service, and the top honor in the nation for inpatient cardiology/telemetry two years in a row.
For more information about The Wisconsin Heart Hospital, its award-winning care and outstanding outcomes, log on to http://www.twhh.org or contact Mary McIntosh at 414-778-7810.
About Cardica, Inc. (Nasdaq: CRDC )
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 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 regarding Cardica, including statements relating to the feature and benefits of the C- Port Flex A 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 degree of market acceptance for our products 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, 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.
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