Dextera Reports on First 50 Cases with Next-Generation Surgical Stapler
November 02 2016 - 12:30PM
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 that the next-generation MicroCutter 5/80 surgical
stapler has now been successfully used to treat 50 patients by
leading surgeons around the world.
In thoracic, pediatric, general and urologic
surgery cases, surgeons assessed the MicroCutter 5/80’s performance
including hemostasis, staple line quality, and procedure-enabling
aspects of the device. This assessment demonstrated overall
excellent performance, hemostasis and reliability in real-world
clinical use in both thin and medium tissue, and further validated
the clinical benefits of the MicroCutter 5/80.
Leading surgeons and centers in the U.S. and Europe
participated, including Prof. Dr. Johannes Bodner, M.Sc., of
Klinikum Bogenhausen, Munich, Germany, and Joel Dunning, M.D., of
James Cook University Hospital, Middlesbrough, UK, who used the
stapler to perform a variety of surgical procedures.
“The MicroCutter’s low profile and wide
articulation allow me to navigate into small spaces better than
traditional staplers,” said Prof. Bodner.
“The MicroCutter demonstrated excellent
hemostasis,” said Dr. Dunning. “This device has made it easier to
perform less-invasive approaches to thoracic surgery including both
uniportal and microlobectomy techniques, which lead to reduced pain
and shorter hospital stays.”
“We are pleased to have reached this milestone and
to now be able to offer both white and blue reloads for thin and
medium tissue, which broadens the applicability of the MicroCutter
5/80 to a wider number of procedures,” said Julian Nikolchev,
president and CEO, Dextera Surgical. “We are very excited to be
working with highly respected pioneers aligned with our goal of
enabling cutting-edge procedures that push minimally invasive
surgery forward.”
MicroCutter Indication Information
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 SurgicalDextera
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.
The company's signature proprietary technology, the
MicroCutter 5/80 Stapler, is the world's first and only
five-millimeter surgical stapler that articulates to 80 degrees in
each direction. As the smallest-profile articulating stapler
available today, the MicroCutter 5/80 Stapler may reduce the amount
of dissection and tissue handling required to position the stapler
in confined spaces, enabling access to difficult-to-reach
anatomy. The cartridge-based device's small size and wide
articulation range are designed to enhance the surgeon's access and
visualization at the surgical site and to mitigate limitations on
the advancement of minimally invasive surgical approaches created
by larger stapling devices.
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 expected benefits of
using the MicroCutter 5/80 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 Annual
Report on Form 10-K for the year ended June 30, 2016, under
the caption “Risk Factors,” filed with the U.S. Securities and
Exchange Commission on October 12, 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.
Contact:
Bob Newell
Vice President, Finance and Chief Financial Officer
(650) 331-7133
investors@cardica.com
Media:
Kelly Morrison
+1 (224) 240-1481
kelly@kellyamorrison.com