Dextera Surgical’s MicroCutter 5/80 Featured in Preclinical Laparoscopic Nephrectomy Study at SAGES Annual Meeting
24 March 2017 - 12:00AM
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.
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 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.
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Dextera Surgical Inc.Bob Newell, 650-331-7133Vice President,
Finance and Chief Financial
Officerinvestors@dexterasurgical.com