Dextera Surgical Inc. (Nasdaq: DXTR), a company developing and commercializing the MicroCutter 5/80™ stapler, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to use its MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads in conjunction with open solid organ parenchymal dissection techniques including organs such as the liver, kidney, pancreas and spleen.
Regarding the benefits, Brendan C. Visser, M.D., associate professor of surgery at Stanford University Medical Center said, “The small size and large degree of articulation provided by the MicroCutter 5/80 is especially beneficial in maneuvering within the confined spaces around solid internal organs.” He aded, “In addition, with the small footprint of the MicroCutter’s jaws, I’m able to successfully operate with less dissection.”
The MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue and Curved Tip White and Blue 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. With the current clearance, the MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins four to five millimeters in diameter and arteries three to seven millimeters in diameter.
“This clearance expands our reach in the United States into a new clinical area for which we have already demonstrated success in Europe,” said Julian Nikolchev, president and CEO of Dextera Surgical Inc. “This expanded indication represents an additional 44,000 procedures in the United States annually, and we look forward to bringing the MicroCutter 5/80 to surgeons for these applications,” concluded Nikolchev.