Cardica, Inc., a comany designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures, has received US Food and Drug Administration'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.
In addition, Cardica 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. With these clearances received Cardica does not have any other submissions pending at the FDA.
"My patients will benefit from the significant advances in stapling technology offered by the 5mm XCHANGE 30," said Mark Wulkan, MD, professor of surgery and chief of the division of paediatric 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."