Cardica Issues MicroCutter XCHANGE 30 510(k) Application for Marketing Clearance

Cardica, Inc.

today announced that it filed regulatory documents with the U.S. Food and Drug Administration (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 through a 5 mm trocar. The submission to the FDA includes the results of Cardica's recently completed MicroCutter European Trial (MET1). In the MET1 study, 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.