Cardica announced the completion of enrollment for the European clinical study of its MicroCutter XCHANGE 30, which is a cartridge-based cutting/stapling device with a 5-millimeter shaft diameter and a cross-sectional area that is more than six times smaller than the standard 12-millimeter surgical staplers currently in use.
The trial has been created to evaluate the XCHANGE 30's safety in various gastrointestinal surgical procedures in support of a 510(k) filing for market clearance from the FDA. The company expects to file regulatory documents with the FDA in the third quarter of calendar 2013, based on consistent product performance and positive unaudited clinical outcomes of the trial so far.
"We would like to express our sincere thanks to the investigators and patients for their enthusiasm in participating in the trial to advance the XCHANGE 30, the smallest cutting and stapling device available today," said Cardica President and CEO Bernard A. Hausen, M.D., Ph.D.
In total, 160 patients have been enrolled at seven centers in Germany for the prospective, single-arm, multicenter, non-inferiority clinical study. The procedure results will be contrasted with historical adverse event reports for comparable procedures performed with currently available stapling devices. Adverse events typically associated with current surgical staplers include staple line leakage, staple line bleeding, staple line strictures, and surgical infections.
A designer and manufacturer of proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures, Cardica possesses a technology portfolio that is intended to minimize operating time and enable minimally invasive and robot-assisted surgeries. The company manufactures and markets its automated anastomosis systems, which include the C-Port Distal Anastomosis Systems and PAS-Port Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery, and Cardica has shipped more than 45,200 units worldwide.
For more information, visit www.cardica.com
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