Dextera Surgical Inc. (Nasdaq: DXTR), a company developing and
commercializing the Dextera MicroCutter 5/80™ Stapler, today
announced that several leading surgeons highlighted the use of
Dextera’s C-Port® Distal and PAS-Port® Proximal Anastomosis Systems
as well as the MicroCutter 5/80 Stapler in a variety of less
invasive surgical procedure presentations at the 14th Annual
International Society for Minimally Invasive Cardiothoracic Surgery
(ISMICS) meeting, held in Rome, Italy.
“Dextera’s complete product line was featured in several
presentations at the ISMICS meeting this year, showcasing the
ability of our products to help enable less invasive cardiothoracic
surgical procedures to improve patient outcomes,” said Julian
Nikolchev, president and CEO of Dextera Surgical. “Importantly, in
addition to growing demand for the MicroCutter 5/80, we are
experiencing a renewed interest in our cardiac products from key
opinion leaders based on patient requests for minimally invasive
surgeries.”
Cardiac Anastomosis Product Presentations
Two oral presentations featured Dextera’s automated anastomosis
devices as an enabling tool for minimally invasive coronary bypass
procedures. An anastomosis is the joining of two vessels together
and is critical to a successful coronary bypass procedure.
Dextera’s cardiac products are the only automated anastomosis
products on the market today.
On Wednesday, June 7 during the Minimally Invasive Coronary
Artery Bypass Graft (CABG) session, Mahesh K. Ramchandani, M.D.,
vice chair of cardiovascular surgery at Houston Methodist Hospital,
demonstrated the use of the PAS-Port System to facilitate a
minimally invasive direct coronary artery bypass (MIDCAB)
procedure.
Also on June 7, Husam H. Balkhy, M.D., director of the Robotic
and Minimally Invasive cardiac surgery program at the University of
Chicago Medicine, gave an invited presentation at the Masters
session on Hybrid Coronary Artery Bypass Graft (CABG), Endovascular
Coronary Skills, and Anastomotic Connectors session highlighting
the use of the C-Port System to connect the bypass graft during
totally endoscopic robotic cardiac surgery.
“The need for a hand-sewn anastomosis during a robotic bypass
procedure has been one of the biggest factors preventing wider
adoption of Totally Endoscopic Coronary Artery Bypass (TECAB)
procedures to date,” commented Dr. Balkhy. “I have been using the
only available automated anastomosis tool - the C-Port Flex-A®
System - to precisely and reliably connect the graft to the
coronary artery, and eliminate the need for a hand-sewn
anastomosis. This device allows me to perform TECAB procedures more
safely and in a broader range of patients in a much less invasive
manner.”
The C-Port device was also featured in three other presentations
in the cardiac surgery plenary session on Thursday June 8. Dr.
Balkhy presented a paper detailing the use of the device to
effectively execute the TECAB procedure on high risk patients; Dr.
Hiroto Kitahara presented on the robotic cardiac surgery experience
at the University of Chicago and highlighted the importance of the
C-Port Flex A in robotic TECABs; and, Dr. Diego Avella presented a
video of a unique case of combined robotic left lobectomy and TECAB
using the C-Port device which allowed the patient to be discharged
in 2 days. In addition, the device was described as being necessary
for the execution of robotic TECABs in two posters presented at the
meeting by the University of Chicago team.
MicroCutter 5/80 Presentations
On Thursday, June 8, Joel Dunning, M.D., of James Cook
University Hospital, presented “VATS Microlobectomy: How do I do
it” to demonstrate his unique approach to performing
minimally-invasive lobectomies. This invited lecture was part of
the Thoracic Masters Class, a session designed to provide specific
instruction on the procedures expected to advance minimally
invasive surgery. On Saturday, June 10, during session 1 of the
Thoracic Movie Day, Marco Nardini, M.D., also of James Cook
University Hospital, presented “Microlobectomy, with Day 1
Discharge,” to demonstrate that many patients go home the day after
Microlobectomy surgery. Both presentations highlighted the use of
the MicroCutter 5/80 to help enable Microlobectomy procedures.
About the C-Port® Distal Anastomosis
Systems (C-Port systems)
In the United States, the C-Port Anastomosis Systems are
intended for use in the creation of anastomoses in blood vessels
and grafts, including use in coronary artery bypass grafting
procedures. The C-Port systems – the C-Port xA system and the
Flex-A® system – can be used on- or off-pump and create
compliant anastomoses that expand and contract with blood flow. The
C-Port systems work on coronary arteries as small as 1.3
millimeters in internal diameter and work with grafts of various
diameters and vessels with single wall thicknesses less than 0.75
millimeters. The Flex-A system allows surgeons to position the
device to create a secure connection even in difficult to reach
areas of the heart.
About the PAS-Port® Proximal Anastomosis System
In the United States, the PAS-Port® System is intended to create
the aortic anastomosis of aortic autologous vein grafts. The
PAS-Port system is a fully-automated device used to perform an
anastomosis between a saphenous vein and the aorta during either
on- or off-pump CABG surgery. The PAS-Port system has been used in
Japan and Europe since 2004, and received 510(k) clearance in the
United States in 2008. The PAS-Port system allows a surgeon to
complete an automated connection of the bypass graft vessel to the
aorta (known as a proximal anastomosis) without the need to clamp
and manipulate the aorta. The common method of completing a
proximal anastomosis in CABG surgery often requires that the aorta
be clamped and utilizes time-consuming hand-sewn sutures. When the
clamp is released, tiny blood clots or particles from the aortic
wall can be released, which can then travel to the brain and cause
stroke and other neurologic complications. In addition, the
PAS-Port's unique design allows for a comparable take-off angle
when compared to hand-sewn sutures, and the PAS-Port's implant
design does not introduce metal into the graft lumen.
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 the expected
future benefits the MicroCutter 5/80, C-Port and PAS-Port devices
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 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 March 31,
2017, 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