Cardica, Inc. (Nasdaq: CRDC) today announced that 109 patients have been enrolled in the company's European clinical trial designed to evaluate the safety of its MicroCutter XCHANGET 30 cutting/stapling device in a variety of surgical procedures. Cardica plans to complete enrollment of 160 patients for the European clinical trial in the second calendar quarter of 2013.
"We are making progress with the MicroCutter XCHANGE 30 in Europe," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica. "In the last four weeks, we have enrolled an additional 19 patients in our clinical trial, with more scheduled in the days ahead. And, we continue to gain valuable feedback from European surgeons deploying the device in a variety of procedures, to prepare the device for broader distribution in the near future. To date the MicroCutter XCHANGE 30 device has been used in over 280 procedures and deployed more than 800 times." About Cardica Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica's technology portfolio is intended to minimize operating time and enable minimally-invasive and robot-assisted surgeries. Cardica manufactures and markets its automated anastomosis systems, the C-Port@ Distal Anastomosis Systems and PAS-Port@ Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery, and has shipped over 44,100 units throughout the world. In addition, Cardica is developing the Cardica@ MicroCutter XCHANGET 30, a cartridge-based microcutter device with a five-millimeter shaft diameter, and the Cardica@ MicroCutter XPRESST 30, a true multi-fire laparoscopic stapling device. Both MicroCutter devices are designed to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery. The Cardica MicroCutter XCHANGE 30 and XPRESS 30 products require 510(k) review and are not yet commercially available in the U.S.