FDAnews Device Daily Bulletin

Cardica Receives 510(k) Nod for MicroCutter XCHANGE 30 Device

Jan. 10, 2014

Redwood City, Calif.-based Cardica has garnered FDA 510(k) clearance for its MicroCutter XCHANGE 30 device for use in minimally invasive laparoscopic gastrointestinal procedures and appendectomies.

The device contains reloadable cartridges of blue staples for medium thickness or white staples for thinner tissues, with a 30 mm staple line and its own integrated knife. The system has 80 degrees of articulation, giving greater access to difficult-to-reach anatomy, according to Cardica. The stapler’s small size reduces the amount of tissue dissection and handling involved to position the device adequately, the company says.

With its small size and broad articulation, the MicroCutter XCHANGE 30 “improves access and visualization” and reduces scarring to promote faster healing at the access site, Cardica Chief Financial Officer Robert Newell told Device Daily Bulletin.

Cardica plans to launch the device in the U.S. market this quarter. It is currently marketed in Europe, with marketing authorization pending in Japan. — Lena Freund

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