In addition to its European commercial introduction, Cardica expects to resume its European clinical trial with the XCHANGE 30 in the second calendar quarter of 2012 to support a regulatory filing in the United States. The MicroCutter XCHANGE 30 requires regulatory clearance through a 510(k) application process with the Food & Drug Administration and is not yet commercially available in the U.S.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 38,000 units throughout the world. In addition, Cardica is developing the Cardica MicroCutter XCHANGE™ 30, a cartridge-based microcutter device with a 5 millimeter shaft diameter, and the Cardica MicroCutter XPRESS™ 30, a true multi-fire laparoscopic stapling device 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.
Cardica Applies CE Mark To Its MicroCutter XCHANGE™ 30 Surgical Cutting And Stapling Device
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