MAINZ, Germany, July 25, 2016 (GLOBE NEWSWIRE) -- 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 literature i 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 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.
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 Statements The 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 .
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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
