Dextera Announces Enrollment of First U.S. Patient in MATCH Registry
December 08 2016 - 3:23PM
Business Wire
Registry Will Gather Important Clinical Data on
Use of the MicroCutter 5/80 in Lung Surgery
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.
Forward-Looking Statements
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161208006160/en/
Dextera SurgicalInvestors:Bob Newell,
650-331-7133investors@dexterasurgical.comorMedia:Jessica Volchok,
310-849-7985jessica@nicoleosmer.com