REDWOOD CITY, Calif.--(BUSINESS WIRE)--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.
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.