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Dextera Surgical’s Microcutter 5/80 Used for First Time in Infant Serial Tranverse Enteroplasty (STEP) Procedures
-- Results Presented at
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
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) (
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
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 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.
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
Dextera Surgical Inc.