Healthcare Industry News: Cook
News Release - January 22, 2008
Cardica Launches New C-Port(R) xA X-CHANGE(TM) System in the United StatesProduct to be Featured at The Society of Thoracic Surgeons Annual Meeting
REDWOOD CITY, Calif., Jan. 22 (HSMN NewsFeed) -- Cardica, Inc. (Nasdaq: CRDC ) today announced the launch of its new C-PortŪ xA X-CHANGE(TM) Distal Anastomosis System, now commercially available in the United States. The C-Port xA X-CHANGE system, a cartridge-based, reloadable C-Port system, allows surgeons to attach multiple blood vessel grafts using the same handle during a coronary artery bypass graft (CABG) procedure, which may reduce costs. Cardica plans to feature the product at The Society of Thoracic Surgeons 44th Annual Meeting, the largest gathering of cardiothoracic surgeons in North America, being held January 28-30, in Fort Lauderdale, FL.
"We are pleased to offer the cartridge-based C-Port xA X-CHANGE system in response to feedback from surgeons desiring a solution to address all of their bypass needs with a single handle, which is less expensive than using a new C-Port system for each anastomosis," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "With the introduction of this product, we will continue to provide surgeons with the same mechanically-governed, reproducible anastomoses while enhancing the functionality and providing the ability to perform multiple anastomoses with one device."
The C-Port xA X-CHANGE system accommodates cartridges pre-loaded with staples, allowing a surgeon to complete multiple anastomoses using the same CO2-powered handle. Each device in the C-Port system product line is designed to enable automated, reliable and reproducible connections of blood vessels during cardiac bypass surgery. Unlike most hand-sewn anastomoses, Cardica's C-Port systems create compliant anastomoses that can expand and contract with blood flow. In addition, the C-Port anastomosis systems, whether used during on- or off- pump surgery, offer surgeons unique access to a wide range of coronary arteries, particularly small coronary arteries, which, in the past, have been difficult or impossible to connect effectively.
The product received 510(k) clearance from the U.S. Food and Drug Administration in December 2007.
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-PortŪ Distal Anastomosis Systems are marketed in Europe and the United States. The PAS-PortŪ 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 with Cook Incorporated to facilitate vascular closure and other surgical procedures.
This press release contains "forward-looking" statements, including statements relating to the expected cost savings created by the C-Port xA X-CHANGE system. Any statements contained in this press release that are not historical facts may be deemed to be forward-looking statements. The words "will", "may," and 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 market acceptance of Cardica's C-Port and C-Port xA X-CHANGE systems and long-term patency of CABG grafts completed with Cardica's C-Port and C-Port xA X-CHANGE systems, 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 fiscal quarter ended September 30, 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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