Medical device distributor Century Medical has sought approval for Cardica’s cartridge-based microcutter device, called MicroCutter XCHANGE 30, from the Japanese regulatory agency.
The submission to Japan’s pharmaceuticals and medical devices agency includes design, validation and verification of data for the Cardica device. Cardica is a manufacturer of stapling and anastomotic devices for cardiac and laparoscopic surgical procedures.
Century Medical president and CEO Akira Hoshino said that the MicroCutter XCHANGE 30’s small size and maneuverability will offer surgeons a significant advantage over conventional staplers.
Following the approval, Century Medical plans to launch the cartridge in Japan by 2014.
Cardica president and CEO Dr Bernard Hausen said that Century Medical is an ideal partner for the company in Japan.
"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," Hausen added.
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The microcutter device is currently available in select centres in Europe, and is not yet commercially available in the US.
Featuring a 5mm shaft diameter, the device is used in bariatric, colorectal, thoracic and general surgeries.
MicroCutter XCHANGE 30, which uses reloadable cartridges with a 30mm staple line length, features a cross-sectional area six times smaller than conventional staplers.
Laparoscopic procedures are performed through 5mm to 10mm trocars ports; however, to accommodate conventional stapling technology, surgeons use 12mm to 15mm trocars, which can ultimately lead to post-operative pain, infection or ventral hernias in patients.
For advanced laparoscopic surgeries, XCHANGE 30 with its smaller cross-sectional area, diameter and higher articulation enable easier access through smaller, less-invasive ports, and faster reach to key organs and tissue.