Cardica, Inc. has completed enrollment in the European clinical study for its MicroCutter XCHANGE 30, a cartridge-based cutting/stapling device with a 5-millimeter shaft diameter and cross-sectional area more than six times smaller than standard 12-millimeter surgical staplers used today. The trial is designed to evaluate the safety of the XCHANGE 30 in a variety of gastrointestinal surgical procedures to support a 510(k) filing for market clearance from the US Food and Drug Administration (FDA).
"Based on consistent product performance and positive unaudited clinical outcomes of the trial to date, following standard statistical analyses we expect to file regulatory documents with the FDA in the third quarter of calendar 2013," said Bernard A Hausen, MD, Ph.D., president and chief executive officer of Cardica. "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."
The prospective, single-arm, multi-centre, non-inferiority clinical study enrolled 160 patients at seven centres in Germany. The results of the procedures will be compared to historical adverse event reports for similar procedures performed with currently available stapling devices. Typical adverse events associated with current surgical staplers include staple line leakage, staple line bleeding, staple line strictures and surgical infections.
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures.The company 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 45,200 units throughout the world.