REDWOOD CITY, Calif., June 30, 2011 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that it has completed the internal design verification process for its proprietary Microcutter XPRESS™ 30 surgical cutting and stapling device necessary to apply the CE Mark to this product for commercial use in Europe. Cardica plans to initiate first-in-man use of the XPRESS 30 in selected European centers starting in July.
"Our internal verification process is both rigorous and comprehensive, intended to comply with all regulatory requirements in the United States and Europe. We are pleased to have successfully accomplished this critical step toward the commercialization of our XPRESS 30 device in Europe," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "With this milestone complete, we have scheduled several laparoscopic cases in Europe using the XPRESS 30, our first true multi-fire microcutter device that we plan to commercialize."
About Cardica's Microcutter Product Line
Cardica's Microcutter surgical cutting and stapling product line is designed to provide true multi-fire endoscopic stapling in a variety of procedures, including colorectal, thoracic and general surgery. The Microcutter product line is designed to cut and staple continuously, allowing a surgeon to complete successive deployments without removing the device for a cartridge reload. The first device that Cardica intends to commercialize in its Microcutter product line, the Microcutter XPRESS™ 30, has a shaft that is 8 mm in diameter, compared to commercialized stapling products with shafts that are at least 12 mm in diameter. The smaller diameter of the anticipated Microcutter line allows access through smaller, less-invasive ports and, importantly, through trocars used for the other surgical tools required for laparoscopic procedures. All of Cardica's Microcutter products under development require regulatory clearance through the 510(k) with the Food & Drug Administration and are not yet commercially available in the U.S.