Cardica has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its MicroCutter Xchange 30 white cartridge and for an additional plastic material contained within the blue cartridge for use in medium thickness tissue.
The FDA has approved MicroCutter Xchange 30 white cartridge in January 2014 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.
Cardica had submitted a special premarket notification 510(k) application for the plastic material for the MicroCutter Xchange 30 device.
With these 510(k) approvals received, Cardica does not have any other submissions pending at the FDA.
Emory University School of Medicine pediatric surgery division chief and professor of surgery Dr Mark Wulkan noted the patients will benefit from the significant advances in stapling technology offered by the 5mm Xchange 30.
"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," Dr Wulkan added.