08.21.13
Cardica Inc. has filed for a 510(k) clearance with the U.S. Food and Drug Administration (FDA) for its Microcutter Xchange 30, a cutting and stapling device designed to be used in multiple open and minimally invasive surgical procedures. According to Cardica, 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 reportedly provides greater access through a 5 mm trocar.
The company’s FDA submission includes the results of its 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,” said 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.”
Currently, the Microcutter Xchange 30 is available in certain European countries, having been granted CE mark approval in March last year.
Cardica makes proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures, and is headquartered in Redwood City, Calif.
The company’s FDA submission includes the results of its 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,” said 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.”
Currently, the Microcutter Xchange 30 is available in certain European countries, having been granted CE mark approval in March last year.
Cardica makes proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures, and is headquartered in Redwood City, Calif.