c has submitted 510(k) application to the U.S. Food and Drug Administration (FDA) for marketing clearance of its MicroCutter XCHANGE 30, a cutting and stapling device designed to be used in multiple open and minimally invasive surgical procedures.
The MicroCutter XCHANGE 30's 5mm diameter shaft, 80 degrees articulation and single-handle design provide unparalleled access, reach and miniaturization across a wide range of procedures.
The device with its cross-sectional area six times smaller than conventional staplers offers surgeons a significant advantage over conventional staplers.
The FDA will also review the results of recently completed European trial (MET1), which only reported one device-related adverse event in 160 patients enrolled and 423 deployments.
Cardica president and CEO Dr Bernard A Hausen noted this filing 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.
"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," Dr Hausen added.