- Posted by Dextera MIS
- On June 1, 2017
REDWOOD CITY, Calif. – June 1, 2017 – Dextera Surgical Inc today announced that it has filed a 510(k) with the U.S. Food and Drug Administration for expanded indications for use. The company seeks to expand the indications for the MicroCutter to include liver, pancreas, kidney and spleen surgery.
“These indications account for more than 80,000 procedures in the U.S., where the small size and increased articulation of the MicroCutter 5/80 may contribute to less invasive approaches to treat these patients,” said Julian Nikolchev, president and CEO of Dextera Surgical Inc. “In Europe, where we have the CE Mark for these indications, surgeons are currently using the MicroCutter 5/80 successfully in these applications.”
Currently, the MicroCutter 5/80 Stapler and MicroCutter 30 Reloads are intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix. Dextera Surgical is seeking to expand these indications for use to include use in the liver, pancreas, kidney and spleen surgical procedures.