U.S. FDA 510(k) Clearance for Cardica’s MicroCutter XCHANGE™ 30 White Cartridge

Cardiac and Laparoscopic surgical device company, Cardica, Inc. has gained U.S. FDA 510(k) clearance for its MicroCutter XCHANGE™ 30 white cartridge for the stapling of thin tissue for use in multiple open or minimally-invasive surgical procedures for the transection, resection and/or creation of anastomoses in small and large intestine, as well as the transection of the appendix.

Background

Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. The company’s technology portfolio is intended to reduce operating time and facilitate minimally-invasive and robot-assisted surgeries. Cardica’s MicroCutter XCHANGE™ 30, a cartridge-based articulating surgical stapling device with a five-millimeter shaft diameter, is manufactured and cleared for use in a variety of gastrointestinal procedures and appendectomies in the United States, and is marketed for a wide range of surgical procedures in Europe.

In addition to the newly announced clearance of Cardica’s MicroCutter XCHANGE™ 30 white, it has also obtained 510(k) clearance for an additional plastic material contained within the MicroCutter XCHANGE 30 blue cartridge for use in medium thickness tissue. This material was submitted as a Special Premarket Notification 510(k) for the MicroCutter XCHANGE 30 device, which received FDA clearance in January 2014.

Physician comments

“My patients will benefit from the significant advances in stapling technology offered by the 5mm XCHANGE 30,” said Mark Wulkan, M.D., professor of surgery and chief of the division of pediatric surgery at Emory University School of Medicine and surgeon-in-chief of Children’s Healthcare of Atlanta. “The small size sets the XCHANGE 30 apart from other surgical stapling technologies available, meeting the need for less invasive surgical tools for my patients. I see a particular need for this technology in bowel resections in small patients.”

Source: Cardica, Inc., PR Newswire

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