Cardica Submits MicroCutter XCHANGE30 510(k) Application For Marketing Clearance

(RTTNews) - Cardica, Inc. (CRDC) reported filing regulatory documents with the U.S. Food and Drug Administration or FDA for marketing clearance of the MicroCutter XCHANGE 30, a cutting and stapling device designed to be used in multiple open and minimally invasive surgical procedures. The XCHANGE 30 has a cross-sectional area six times smaller than conventional surgical staplers and articulates up to 80 degrees in each direction. The lower profile provides greater access via. a 5 mm trocar.

The FDA submission includes the results of Cardica's recently completed MicroCutter European Trial or MET1. In the MET1 trial, the MicroCutter XCHANGE 30 met the primary endpoint, freedom of MicroCutter-related severe adverse events when compared to historical controls from the medical literature, with only one event in 160 patients enrolled and 423 deployments.

"The filing of our 510(k) application represents the culmination of effort from many key contributors including the employees who worked tirelessly to deliver an innovative device that addresses a surgical need, the leading physicians who tested the XCHANGE 30 and provided invaluable feedback and the patients that underwent surgical procedures facilitated by the device," said Bernard Hausen, M.D., Ph.D., President and Chief Executive of the company.