Dextera Surgical’s Microcutter 5/80 Used for First Time in Infant Serial Tranverse Enteroplasty (STEP) Procedures
March 30 2017 - 8:30AM
Business Wire
-- Results Presented at German Society of
Surgery Congress --
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 Dr. Oliver Muensterer, head of pediatric
surgery at Johannes Gutenberg University of Mainz, presented
positive case studies using the MicroCutter 5/80 to successfully
complete serial transverse enteroplasty (STEP) procedures in two
infants with short bowel syndrome.
Short bowel syndrome (also known as SBS or short gut) is a
complex disease that causes the body to be unable to absorb enough
nutrients through the small intestine due to a lack of resorptive
tissue within the intestine. SBS occurs congenitally in newborns
when a portion of the intestine is missing at birth, and can also
occur when a portion of the small intestine is removed due to
injury or disease. Newborns with SBS are often completely dependent
on intravenous (IV) nutrition.
“These case studies demonstrate the first time that any
microstapler has been used to complete STEP procedures in short
bowel syndrome patients, with excellent results,” commented Mark S.
Soberman, M.D., medical director of Dextera Surgical and surgeon
and chief physician executive for Monocacy Health Partners at
Frederick Regional Health System. “Dr. Muensterer’s first patient,
a premature newborn infant, received the STEP procedure and
achieved more than 90 percent weaning from IV nutrition 18 months
after surgery. His second patient, a full-term infant, had two
successive STEP procedures performed two months apart, and achieved
more than 80 percent weaning eight months after the second
procedure.”
Dr. Muensterer performed three STEP procedures on two infants
using the MicroCutter 5/80 surgical stapler. The first patient was
born prematurely at 33 weeks. The MicroCutter was used in a STEP
procedure on the first day of life to double the length of the
small intestine from eight centimeters to 16 centimeters. The
second patient, a full-term infant, required two successive STEP
procedures performed two months apart. Dr. Muensterer used the
MicroCutter 5/80 to almost double the length of the small bowel
from 35 centimeters to 65 centimeters. In both procedures, less
intestinal tissue was lost, and thereby more resorptive area was
preserved, by using the MicroCutter 5/80 when compared to
historical procedures using a conventional 12-millimeter diameter
endostapler. More resorptive area within the small intestine has
been shown to lead to faster transition from IV feeding to normal
feeding. There were no intra- or post-operative complications in
either infant. The data were presented orally at the 134th Kongress
Deutsche Gesellschaft fur Chirurgie (DGCH) (German Society of
Surgery) last week in Munich.
The STEP procedure is performed by cutting and stapling a series
of zig zags along the remaining healthy small intestine to increase
the length of the small intestine. While this decreases the
diameter of the small intestine, the overall increase in resorptive
surface area within the intestine created by increased length
results in a net overall positive outcome. In addition, the small
intestine grows in diameter over time, further increasing the
surface area for nutrition absorption. The ultimate goal of the
STEP procedure is weaning from IV nutrition to receive all
nutrition through the mouth.
“Short bowel syndrome results in a high degree of morbidity and
mortality. We are extremely pleased that the MicroCutter 5/80, with
a footprint that is less than half of the size of conventional
staplers, left more resorptive tissue untouched by the jaws of the
stapler during a STEP procedure. For infants in particular, every
millimeter of resorptive tissue matters,” said Liam Burns, vice
president of worldwide sales and marketing. “Importantly, the STEP
surgery represents another innovative pediatric procedure where a
small stapler footprint is just the right instrument to make a
tremendous difference in the lives of these infants and their
families.”
MicroCutter Indication Information
The MicroCutter 5/80 Stapler and MicroCutter 30 Reloads are
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 5/80 may be used with both
MicroCutter 30 White Reloads in vascular/thin tissue and
MicroCutter 30 Blue Reloads for standard 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 Dextera
Surgical’s expectations as to the benefits of using the MicroCutter
5/80 in STEP procedures are "forward-looking statements." There are
a number of important factors that could cause Dextera Surgical’s
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 December 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.
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Dextera Surgical Inc.Bob Newell, 650-331-7133Vice President,
Finance and Chief Financial
Officerinvestors@dexterasurgical.com