Dextera Surgical Receives Expanded Indication in Solid Organ Surgery for MicroCutter 5/80™
August 31 2017 - 8:30AM
Business Wire
-- Including Liver, Pancreas, Kidney and
Spleen Surgical Procedures –
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.
“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,” said Brendan C.
Visser, M.D., associate professor of surgery at Stanford University
Medical Center. “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.”
About Dextera Surgical
Dextera Surgical 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 the beneficial
use of the MicroCutter 5/80 in open solid organ surgery, the
expanded indication representing an additional 44,000 procedures in
the United States and bringing the MicroCutter 5/80 to surgeons for
this extended use 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170831005206/en/
Dextera Surgical Inc.Bob Newell, 650-331-7133Vice President,
Finance and Chief Financial
Officerinvestors@dexterasurgical.com