Century Medical, Inc. has filed for regulatory approval of Cardica's MicroCutter XCHANGE 30 cutting and stapling cartridge in Japan. The submission to the Pharmaceuticals and Medical Devices Agency (PMDA) includes design, validation and verification data for the MicroCutter XCHANGE 30 cartridges.

The XCHANGE 30 cartridges are used together with the XCHANGE 30 device to perform surgical procedures.

"We believe that the MicroCutter XCHANGE 30, with its small size and maneuverability, offers surgeons a significant advantage over conventional staplers," said Akira Hoshino, president and chief executive officer of Century Medical, Inc. "We anticipate launching this revolutionary device in Japan during 2014."

"Century Medical is an ideal partner for Cardica in Japan, with surgical stapling expertise and product familiarity as our exclusive Japanese distributor for the PAS-Port Proximal Anastomosis System," commented Bernard A Hausen, MD, Ph.D., president and chief executive officer of Cardica. "We anticipate that Japan will become an important market for the MicroCutter XCHANGE 30 due to the focus of Japanese surgeons on less invasive procedures."

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 degrees. The device uses reloadable cartridges with a 30-millimeter staple line length. Laparoscopic procedures today are primarily performed through 5- to 10-mm trocars ports. To accommodate conventional stapling technology, however, surgeons are forced to use 12- or 15-mm 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.

Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures.