US-based medical device company Cardica has received 510(k) clearance from the US Food and Drug Administration (FDA) for its MicroCutter Xchange 30 cutting/stapling device and blue staple cartridge for medium thickness tissue.
The FDA granted the marketing approval for the MicroCutter Xchange 30 device and blue staple cartridge for medium thickness tissue for use in multiple open or minimally-invasive surgical procedures for the transection, resection and creation of anastomoses in small and large intestine, as well as the transection of the appendix.
This FDA 510(k) clearance is based on data submitted from Cardica’s European clinical trial, which evaluated the cartridge-based, minimally invasive stapling system in a variety of gastrointestinal surgical procedures. In the clinical study, the Xchange 30 has met the primary endpoint.
Cardica president and CEO Dr Bernard A Hausen said: "We have been working with leading European surgeons in a commercial setting over the past year to optimise this device for use in both open and laparoscopic procedures. We look forward to implementing a selective commercial launch in the United States in the months ahead to address the growing need for a smaller surgical stapling device.
"Looking beyond the initial introduction, we plan to submit our 510(k) premarket notification for the white stapling cartridge for thin tissue and blood vessels also used with the Xchange 30 device, in the current quarter, to further expand the device’s applicability in surgical procedures."
MicroCutter Xchange 30 has 5mm shaft diameter and cross sectional area significantly smaller than 12mm conventional staplers. The device provides articulation of up to 80 degrees.
Xchange 30’s size and degree of articulation allows surgeon to enhance their access and visualisation at the surgical site.
Cardica has designed the new system to mitigate limitations on surgical procedures created by larger stapling devices.
This device uses reloadable cartridges with a 30mm staple line length and an integrated knife and is currently indicated to fire up to six times per device.