Cardica said it filed all paperwork for a 510(k) for its MicrroCutter Xchange 30, which is already on the shelves in Europe. The U.S. is the largest market for surgical staplers world wide, according to the company.
The FDA will review supporting evidence for the MicroCutter based on a recently completed European trial, which only reported 1 device-related adverse events out of 160 patients who went under the knife with MicroCutter.
MicroCutter is designed to reduce complications and post-operative pain from laparoscopic surgery. It has a much smaller cross-sectional area than typical surgical staplers, and can articulate 80 degrees, according to Cardica.
The company promised to submit the U.S. application after submitting a cartridge design validation application to Japan’s Pharmaceuticals & Medical Devices Agency August 13.