Cardica Inc. received FDA approval for the MicroCutter XCHANGE 30 Stapler in January 2016.
The MicroCutter XCHANGE 30 Stapler is a cartridge-based, minimally-invasive linear stapler with an articulating 5mm diameter shaft. It is capable of 360-degree shaft rotation, and articulation of 80-degrees in each direction. The stapler can be introduced through a 5mm port; it delivers four rows of D-shaped stainless steel staples, while simultaneously transecting tissue between staple rows. Staple line length is 30mm, with a transection length of 27mm.
The stapler can be fired 6 times per device. It can be used with white cartridges, for division of thin tissue and vascular structures, and with blue cartridges, to divide medium-thickness tissue. The staple cartridges are available with either straight or curved tips.
The FDA determined the stapler is substantially equivalent to predicate devices. Overall performance and tissue burst pressure of the MicroCutter XCHANGE Stapler was demonstrated to be equivalent to the Ethicon PROXIMATE linear stapler, as well as the Ethicon ENDOPATH endoscopic linear stapler.
FDA approved indications for use:
- Transection of the appendix.
- Transection, resection, and creation of anastomoses in the small and large intestine
- Transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures.
SAGES Technology & Value Assessment Committee
Tech Alert, April 2016
By Nova Szoka, MD