Cardica, a medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its MicroCutter Xchange 30 device and blue staple cartridge for medium thickness tissue.
The company has designed 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/or creation of anastomoses in small and large intestine, as well as the transection of the appendix.
The FDA has granted marketing approval based on the data submitted by Cardica from its European clinical trial, evaluating the cartridge-based, minimally-invasive stapling system in a variety of gastrointestinal surgical procedures.
The clinical study, which enrolled 160 patients, has met the primary endpoint.
Cardica president and CEO Dr Bernard A Hausen noted the company is extremely pleased to achieve this important corporate milestone, allowing it to market the MicroCutter Xchange 30 in the US.
"We have been working with leading European surgeons in a commercial setting over the past year to optimize 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," Hausen added.
The MicroCutter Xchange 30 has a 5mm shaft diameter and cross sectional area significantly smaller than 12mm conventional staplers. The size and degree of articulation enhances the surgeon’s access and visualization at the surgical site.
Cardica claims that the Xchange 30 is the smallest diameter cutting and stapling device available today, with articulation up to 80 degrees and single-handed operation. The 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.