Dextera Surgical’s MicroCutter Stapling Technology Used in First Stapler-Enabled Pediatric Laparoscopic Duodenal Repair
July 25 2016 - 8:00AM
The MicroCutter 5/80 stapler, the world’s smallest profile
articulating surgical stapler, continues to enable the advancement
of minimally invasive surgeries worldwide with a first-of-its kind
use in a laparoscopic duodenal atresia repair in a newborn. Leading
pediatric surgeon Oliver Muensterer, M.D., Ph.D., Professor and
Chairman of Pediatric Surgery, University Medical Center of the
Johannes Gutenberg University, Mainz, performed the challenging
laparoscopic repair, known as duodenoduodenostomy, earlier this
month. During the procedure, Dr. Muensterer used the MicroCutter
5/80 stapler as an alternative to hand sewn anastomosis.
Duodenal atresia is a birth defect that occurs when there is a
narrowing or blockage of the first part of the small bowel, also
known as the duodendum, where the intestine ends blindly. Surgery
is needed to reconnect the two parts of the duodenum to reestablish
normal flow of nutrients, often within the first few days of
life.
Laparoscopic surgery for duodenal atresia repair is technically
challenging for surgeons to perform, especially in neonates, due to
the small space available for suturing of the anastomosis (i.e.,
the rejoining of the two tubular ends of the duodenum to bypass the
blockage). While extensive clinical literaturei shows that a
stapled anastomosis produces better outcomes than hand sewn bowel
anastomosis, including lower leak rates, less stricture and reduced
infections, the small abdominal space in a newborn makes it
virtually impossible to perform anastomosis laparoscopically using
a conventional surgical stapler. In addition to potential
differences in outcomes, hand sewn anastomosis takes much longer to
complete, which can place additional stress on the tiny patient. In
this case, Dr. Muensterer was able to perform the anastomosis
procedure effectively with the use of the MicroCutter 5/80 stapler,
which has a shaft diameter of only 5 mm (vs. 12mm for most
conventional staplers) and provides 80 degrees of
articulation.
“The small size of the MicroCutter made it possible to use a
stapler in this tiny patient. It also reduced operating time
significantly, which is especially important in newborns,” Dr.
Muensterer said. “The MicroCutter makes this procedure easier to
perform laparoscopically by eliminating the need for a hand sewn
anastomosis, and may accelerate the adoption of minimally invasive
techniques for pediatric patients.”
“Challenging cases such as this show how the small size and
wider articulation of the MicroCutter stapling technology can
enable more minimally invasive procedures for both pediatric and
adult patients,” said Julian Nikolchev, president and CEO, Dextera
Surgical. “We are proud of the positive impact the MicroCutter
is having in procedures that have previously been limited by the
tight spaces in which surgeons have to operate.”
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.
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.
Forward-Looking StatementsThe statements in
this press release regarding Dextera Surgical's beliefs as to the
benefits expected to be obtained from the use of the MicroCutter
5/80 Stapler, 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: that Dextera Surgical may not be successful in its
efforts to complete the development of its combination device
(designed to use two different size cartridges) or achieve
optimization of Dextera Surgical's supply chain for its combination
device; that Dextera Surgical may not receive regulatory clearance
for indications not currently cleared; as well as other risks
detailed from time to time in the company'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, 2016, 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.
i Data on file
Contact:
Investors:
Bob Newell
Vice President, Finance and Chief Financial Officer
+1 (650) 331-7133
investors@dexterasurgical.com
Media:
Kelly Morrison
+1 (224) 240-1481
kelly@kellyamorrison.com