Officials from Cardica Inc. 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° in each direction. The lower profile provides greater access through a 5mm 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.
"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," comments Bernard A. Hausen, M.D., Ph.D., president and CEO of Cardica. "Pending market clearance by the FDA, we look forward to introducing the MicroCutter XCHANGE 30 in the United States, the world's largest surgical stapling market."
About the MicroCutter XCHANGE 30
Cardica's MicroCutter XCHANGE 30 is available in select centers in Europe today. The device has a cross-sectional area six times smaller than conventional staplers, and articulates up to 80°. The device uses reloadable cartridges with a 30mm staple line length. Laparoscopic procedures today are primarily performed through 5mm to 10mm trocars ports. To accommodate conventional stapling technology, however, surgeons are forced to use 12mm or 15mm trocars, which can result in high post-operative pain, port site infection or ventral hernias. These complications can prolong surgical time, delay discharge, and result in unnecessary hospital readmissions. The smaller cross-sectional area, diameter and much higher articulation of the XCHANGE 30 platform are designed to allow easier access through smaller, less-invasive ports, and to enable faster and easier access to vital organs and tissue for key advanced laparoscopic procedures.