Updated on 13 August 2013
The submission to the PMDA includes design, validation and verification data for the MicroCutter Xchange 30 cartridges.
Singapore: Japan's Century Medical has filed for regulatory approval of US-based 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 Mr Akira Hoshino, president and chief executive officer of Century Medical. "We anticipate launching this revolutionary device in Japan during 2014," he added.
"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 Dr Bernard A Hausen, MD, PhD, 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," Dr Hausen added.