US-based Cardica has sought 510(k) clearance from the US Food and Drug Administration (FDA) for its MicroCutter XCHANGE 30, a cutting and stapling device designed for minimally-invasive surgical procedures.
MicroCutter XCHANGE 30 is a cartridge-based microcutter device designed to be used in a variety of procedures, including bariatric, colorectal, thoracic and general surgery.
The MicroCutter XCHANGE 30's 5mm diameter shaft, 80 degrees articulation and single-handle design provide access through less invasive ports and faster reach to key organs and tissues in a wide range of procedures, the company claimed.
The device, which features a cross-sectional area six times smaller than conventional staplers, offers surgeons an advantage over conventional staplers.
It uses reloadable cartridges with a 30mm staple line length.
Laparoscopic procedures are primarily performed through 5 to 10mm trocars ports; however, in order to accommodate conventional stapling technology, surgeons use 12 or 15mm trocars, which can cause high post-operative pain, port site infection or ventral hernias.
Such complications can prolong surgical time, delay discharge of patients and also cause hospital readmissions.
The submission of the application also includes the results of Cardica's recently-completed MicroCutter European Trial (MET1).
This study, which met the primary endpoint, reported only one device-related severe adverse event out of 160 patients enrolled and 423 deployments.
Cardica president and CEO Dr Bernard A Hausen noted this filing represents the culmination of effort from many key contributors including the employees who worked tirelessly to deliver an innovative device that addresses a surgical need, the leading physicians who tested the XCHANGE 30 and provided invaluable feedback and the patients that underwent surgical procedures facilitated by the device.
"Pending market clearance by the FDA, we look forward to introducing the MicroCutter XCHANGE 30 in the United States, the world's largest surgical stapling market," Dr Hausen said.
Cardica's MicroCutter XCHANGE 30 is currently available at select centres in Europe.