Cardica has submitted application to the European notified body for CE Mark approval of its proprietary cartridge-based, Microcutter Xchange 30 surgical cutting and stapling system.
The Microcutter Xchange 30, with a five-millimeter shaft diameter and articulation up to 80 degrees, is designed to allow easier access through smaller, less-invasive ports, and to enable easier access to vital organs and tissue for advanced laparoscopic procedures.
The device uses reloadable cartridges with a 30 millimeter staple line length.
The cartridge comes with either blue staples for medium tissue thicknesses and white staples for thin tissues such as vascular structures.
Cardica president and chief executive officer Bernard Hausen said the company believes that the Xchange 30 has the potential to improve patient outcomes by reducing adhesions, inadvertent tissue damage, as well as improving patient recovery time.
The company said it expects to resume its European clinical trial with the Xchange 30 in the second calendar quarter of 2012 to support a regulatory filing in the US.