REDWOOD CITY, Calif.--(BUSINESS WIRE)--Dextera Surgical Inc. (Nasdaq:DXTR), a company developing and commercializing the MicroCutter 5/80™ stapler, 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.
About Dextera Surgical
Dextera Surgical (Nasdaq:DXTR) designs and manufactures proprietary stapling devices for minimally invasive surgical procedures. In the U.S., surgical staplers are routinely used in more than one million minimally invasive laparoscopic, video-assisted or robotic-assisted surgical procedures annually.
Dextera Surgical also markets the only automated anastomosis devices for coronary artery bypass graft (CABG) surgery on the market today: the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System. These products, sold by Dextera Surgical under the Cardica brand name, have demonstrated long-term reliable clinical performance for more than a decade.
The statements in this press release regarding the benefits the MicroCutter 5/80 may have for liver, pancreas, kidney and spleen surgery are "forward-looking statements." There are a number of important factors that could cause results to differ materially from those indicated by these forward-looking statements, including the risks detailed from time to time in Dextera Surgical’s reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, under the caption “Risk Factors.” Dextera Surgical expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. You are encouraged to read Dextera Surgical’s reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.