Dextera Surgical (NSDQ:DXTR) said today it won expanded FDA 510(k) clearance for its MicroCutter 5/80 stapler and associated reloads, now cleared for open solid organ parenchymal dissection techniques.
The new clearance covers use on organs including the liver, kidney, pancreas and spleen, the Redwood City, Calif.-based company 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. In addition, with the small footprint of the MicroCutter’s jaws, I’m able to successfully operate with less dissection,” Dr. Brendan Visser of Stanford University Medical Center said in a press release.
The company’s MicroCutter 5/80 stapler is designed for transection and resection procedures in multiple open or minimally invasive urologic, thoracic and pediatric surgical procedures. The system is also designed for applications in transection, resection or creation of anastomoses in the small and large intestine and the transection of the appendix, Dextera said.
“This clearance expands our reach in the United States into a new clinical area for which we have already demonstrated success in Europe. 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,” Dextera Surgical CEO Julian Nikolchev said in a press release.
In May, Dextera said it closed an $8 million public offering of Series B convertible preferred stock to support its MicroCutter 5/80 stapler.