Dextera Surgical Files 510(k) for MicroCutter 5/80™ Expanded Indications
June 01 2017 - 8:30AM
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.
Forward-Looking Statements
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170601005472/en/
Dextera Surgical Inc.Bob Newell, 650-331-7133Vice President,
Finance and Chief Financial
Officerinvestors@dexterasurgical.com