Cardica Applies CE Mark to Microcutter XPRESS 30 Surgical Cutting and Stapling Device

Cardica, Inc. 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."
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