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 leading surgeon Juan-Carlos Verdeja, M.D., presented a poster highlighting the MicroCutter Stapler as a procedure enabling technology in laparoscopic nephrectomy for kidney removal in an animal model.
“The results of the preclinical study show that the MicroCutter had equivalent hemostasis to a conventional three-row surgical stapler in a preclinical study of laparoscopic nephrectomy procedures,” said Dr. Verdeja, associate professor of surgery and director, minimally invasive surgery at Florida International University College of Medicine and chief of general surgery division at Baptist Health Medical Group. “With more surgeons using minimally invasive approaches for nephrectomy and removing donor kidneys, we showed that the slim jaws of the MicroCutter create a small footprint on the vessels, increasing the length of the retained vascular stump by up to 1.6mm, which is especially critical in donor nephrectomy transplant cases.”
In the poster, Dr. Verdeja presented results from 13 firings of the MicroCutter (5 millimeters in diameter) and 14 firings of a conventional three-row endostapler (12 millimeters in diameter). The study evaluated hemostasis (stopping of blood flow) and staple line quality when firing on the renal artery and renal vein as well as the ureter. Importantly, these firings demonstrate the MicroCutter’s performance on blood vessels with systemic pressures that come directly off the aorta and vena cava. After firing the stapler on these vessels, hypertension was induced for three minutes to further challenge hemostasis at the staple line.
The data demonstrate that there was no bleeding at any of the staple lines from either the MicroCutter or the conventional endostapler at initial firing or upon induction of hypertension. There were no adverse events associated with either device. The data were presented at the Society of American Gastrointestinal and Endoscopic Surgeons Meeting (SAGES) in Houston, Texas, beginning Thursday, March 23, 2017 at 10:00 a.m. local time. [Poster # P421] Full study results are expected to be published later this year in a peer-reviewed publication.
“Dr. Verdeja’s data confirm the excellent hemostasis results seen in previous studies of the MicroCutter,” commented Liam Burns, vice president of worldwide sales and marketing. “Additionally, this study demonstrates that the MicroCutter, due to its small footprint and 80 degrees of articulation, may enable less invasive surgical approaches in urology such as donor nephrectomy transplant procedures, extending the applications of our surgical stapler beyond thoracic, pediatric, and general surgery.”
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 donor nephrectomy 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.