Cardica Earns FDA Clearance for New Surgical Stapling Device

Redwood City, Calif.-based Cardica Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to use its Microcutter Xchange 30 surgical stapling device with a white cartridge for the transection and resection in open or minimally invasive urologic, thoracic and pediatric surgical procedures. This clearance complements the existing indications for use of the Microcutter Xchange 30 in surgical procedures in the small and large intestine and in the appendix.

Surgical staplers are routinely used in the United States in more than one million minimally invasive or robotically-assisted laparoscopic surgical procedures annually. At five millimeters and articulating to 80 degrees, the Microcutter Xchange 30 is the smallest-profile articulating stapler available in the world. It is currently available with a white cartridge used to staple vascular and other thin tissue.

“With this important corporate and commercial milestone, the Microcutter’s U.S. indication covers many of the same indications as approved in the European Union,” said Julian Nikolchev, president and CEO of Cardica. “We look forward to introducing this innovative surgical stapler in a limited launch to key opinion leaders throughout the United States, including those surgeons performing video assisted thoracic surgery (VATS) at the annual meeting of the Society of Thoracic Surgeons (STS) in Phoenix, Arizona later this month and leading pediatric surgeons at the American Pediatric Surgical Association annual meeting in San Diego in May 2016. Importantly, our primary company focus will remain the completion of the development for our new combination device, while we optimize our supply chain to ensure adequate supply of the combination device at product launch.”

The Microcutter Xchange 30, the world’s first and only five-millimeter surgical stapler that articulates to 80 degrees, is a cartridge-based, minimally-invasive surgical stapling system. The small size and large degree of articulation enhances the surgeon’s access and visualization at the surgical site. This device is designed to mitigate limitations on the advancement of minimally invasive surgical approaches created by larger stapling devices. As the smallest profile articulating stapler available today, the Microcutter Xchange 30 may reduce the amount of dissection and tissue handling required to position the stapler in confined spaces, enabling access to difficult to reach anatomy.

Cardica makes proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures.