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REDWOOD CITY, Calif.,
March 29, 2012 /PRNewswire/ -- Cardica, Inc. (Nasdaq:CRDC), today announced it has applied Conformite Europeene, or CE Mark, to its proprietary MicroCutter XCHANGE™ 30 surgical cutting and stapling system, or XCHANGE 30, following the completion of design verification. The MicroCutter XCHANGE 30 is a cartridge-based system with a five-millimeter shaft diameter, substantially smaller than current surgical staplers. The MicroCutter XCHANGE 30 is designed for use in laparoscopic and open surgical procedures. Cardica expects to begin its commercial introduction of the XCHANGE 30 in
Europe in the second calendar quarter of 2012.
"We have worked closely with leading laparoscopic surgeons to optimize the design, functionality and reliability of the XCHANGE 30, which we believe is a breakthrough in advanced stapling technology," said
Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "With a cross-sectional area nearly six times smaller than the smallest stapler on the market today, and almost twice the amount of articulation of currently available products, this product greatly reduces access port requirements, and improves access to internal organs in laparoscopic procedures. We believe the XCHANGE 30 has the potential to improve patient outcomes by reducing scarring and adhesions, inadvertent tissue damage, as well as improving patient recovery time."
Cardica's MicroCutter XCHANGE 30 has a substantially smaller shaft diameter than any cutting and stapling device available today, and articulates up to 80 degrees. The device uses reloadable cartridges with a 30 millimeter staple line length. The cartridge comes with either blue staples, for medium tissue thicknesses, or white staples, for thin tissues such as vascular structures. Laparoscopic procedures today are primarily performed through 5 to 10 mm trocars ports. To accommodate conventional stapling technology, however, surgeons are forced to use 12 or 15 mm trocars, which can result in high post-operative pain, port site infection or ventral hernias. These complications can prolong surgical time, delay discharge, and result in unnecessary hospital readmissions. The smaller diameter and much higher articulation of the XCHANGE 30 platform are designed to allow easier access through smaller, less-invasive ports, and to enable faster and easier access to vital organs and tissue for key advanced laparoscopic procedures.