REDWOOD CITY, Calif.--Dextera Surgical Inc. (Nasdaq:DXTR), manufacturer of the smallest-profile and most maneuverable articulating surgical stapling platform on the market for minimally invasive surgery, today announced the enrollment of the first U.S. patient in the MicroCutter Assisted Thoracic Surgery Hemostasis (MATCH) Registry, a prospective, open-label, multi-center registry enrolling up to 120 patients undergoing lung resections in which surgical stapling is required.
The registry will evaluate the effectiveness of the MicroCutter 5/80 surgical stapler for hemostasis (stopping the flow of blood) and the procedure enabling aspects of the device in lobectomy or segmentectomy lung surgery procedures using a variety of minimally invasive techniques including video assisted thoracic surgery (VATS) and robotic assisted surgeries as well as in open surgery.
Leading centers in the United States will be participating in the MATCH Registry, including the Mayo Clinic (Rochester, Minn.), where the first U.S. MATCH patient was enrolled. Additionally, ten patients have already been enrolled internationally at the James Cook University Hospital (Middlesbrough, UK).
Other leading research institutions expected to participate in the MATCH Registry include University of Alabama at Birmingham, the University of Texas MD Anderson Cancer Center, and the Royal Infirmary in Edinburgh, Scotland, as well as several additional international sites.
“The MATCH Registry will provide important clinical data regarding the hemostasis performance of the MicroCutter 5/80 while capturing video evidence of the ability of the device to navigate in tight spaces to enable less-invasive methods for treating patients undergoing lung surgery,” said David Rice, M.B., B.Ch., F.R.C.S.I., professor at the University of Texas MD Anderson Cancer Center, Houston.
“We are proud to be working with these surgical pioneers at leading institutions to gather important clinical data on the MicroCutter 5/80 and its utility in thoracic surgery procedures,” said Julian Nikolchev, president and CEO, Dextera Surgical.
MicroCutter Indication Information
The MicroCutter 5/80 Stapler is the world's first and only five-millimeter surgical stapler that articulates to 80 degrees in each direction. The MicroCutter 5/80 Stapler is manufactured and cleared for use in the United States 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. The MicroCutter 30 White Reload has application in vascular tissue.
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 expected actions of the MATCH Registry and the information it will provide are "forward-looking statements." There are a number of important factors that could cause actual results to differ materially from those indicated by these forward-looking statements, including those described in Dextera Surgical’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, under the caption “Risk Factors,” filed with the U.S. Securities and Exchange Commission on November 10, 2016. 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.