Cardica, Inc. (Nasdaq: CRDC) today announced that the first patients have been enrolled and discharged from the first two investigative sites in a European clinical study to evaluate its MicroCutter™ surgical cutting/stapling devices for transections, resections and anastomoses during gastrointestinal surgical procedures.
The planned MicroCutter product line is designed to provide true multi-fire and reloadable cartridge capabilities, with all MicroCutter devices designed to offer both stapling and cutting functionality. With low force-to-fire and small shaft diameters of eight millimeters for the MicroCutter™ XPRESS™ 30 device and five millimeters for the planned MicroCutter™ XCHANGE™ 30 device, the MicroCutter surgical stapling devices should provide flexibility and wide field access during laparoscopic surgical procedures.
"The MicroCutter surgical stapling technology, for the first time in over a decade, would move the field of surgical stapling forward with its innovative product size and design," said Andreas Kuthe, M.D., chief of general surgery at the Red Cross Hospital Clementinenhaus, Hannover, Germany, and principal investigator of the trial. "The small shaft diameter and ability to reload the MicroCutter in situ may reduce tissue trauma and the invasiveness of the procedure while providing excellent patient outcomes."
This prospective, single-arm, multi-center, non-inferiority clinical study is designed to assess the safety of the MicroCutter XPRESS 30 device and the planned XCHANGE 30 device (subject to Cardica's ability to apply the CE Mark to the XCHANGE 30). MicroCutter surgical stapling devices will be used for transections, resections and anastomoses during gastrointestinal procedures. These results 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 plans to enroll up to 200 patients at up to 10 sites in Europe, with patients evaluated at the time of discharge and 30 days postoperatively.
"The initiation of this non-inferiority study represents a significant milestone for Cardica as we continue on the path toward planned commercialization of MicroCutter devices in the United States," said Bernard A. Hausen, M.D., Ph.D., president and chief executive officer of Cardica, Inc. "We expect enrollment to take approximately six months, and we plan to include the results of this study in a 510(k) submission to the U.S. Food and Drug Administration in the second half of calendar 2012."