TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is
pioneering the use of flexible instruments and robotics to improve
minimally invasive surgery, today announced the first human cases
performed using its recently launched fully flexible advanced energy
device.
The Flex Ligating Shears, which has received 510(k) clearance from the
U.S. Food and Drug Administration, is designed to deliver full
flexibility to the surgeon while offering ligation and division with
direct thermal energy in various laparoscopic surgical procedures.
“TransEnterix now offers the only advanced energy device that completely
articulates 360 degrees to provide optimal access to surgeons within the
operating field, while competing technologies offer limited or no
articulation,” said Todd M. Pope, President and CEO of TransEnterix.
“With the SPIDER Flex Ligating Shears, we can offer surgeons the ability
to attain precise angles when cutting and dividing tissue in a
laparoscopic procedure.”
Advanced energy devices represent one of the most versatile and critical
tools for surgeons in minimally invasive surgery. These devices deliver
controlled energy to effectively ligate and divide tissue while greatly
limiting bleeding in the operative field and minimizing thermal injury
to surrounding structures.
Dr. Andrew Hargroder, a general and bariatric surgeon in Baton Rouge,
Louisiana, was the first surgeon to utilize the new device for sleeve
gastrectomy procedures. “The SPIDER Flex Ligating Shears offered me a
fast and simple way to cut and seal tissue,” said Dr. Hargroder. “The
device created no plume to impair visualization, sealed tissue extremely
well, and appeared to minimize thermal spread. With 360 degrees of
angulation, this device reaches areas where rigid instruments may have
difficulty.”
TransEnterix’s advanced energy device has been created for surgeons to
use with the company’s existing SPIDER Surgical System. The company
intends to offer a similar device in the future for its SurgiBot™
system, a new patient-side robotic surgery system currently under
development.
About TransEnterix
TransEnterix is a medical device company that is pioneering the use of
flexible instruments and robotics to improve minimally invasive surgery.
The company is focused on the development and commercialization of the
SurgiBot™ system, a minimally invasive surgical robotic system that
allows the surgeon to be patient-side within the sterile field. For more
information, visit the company's website at www.transenterix.com.
Forward Looking Statements
This press release includes statements relating to our advanced
energy device and SurgiBot system, as well as our current regulatory and
commercialization plans for the system. These statements and other
statements regarding our future plans and goals constitute “forward
looking statements” within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and
are intended to qualify for the safe harbor from liability established
by the Private Securities Litigation Reform Act of 1995. Such statements
are subject to risks and uncertainties that are often difficult to
predict, are beyond our control, and which may cause results to differ
materially from expectations. Factors that could cause our results to
differ materially from those described include but are not limited to:
the pace of adoption of our product technology by surgeons, including
the Flex Ligating Shears Advanced Energy Device; whether the SPIDER Flex
Ligating Shears can offer surgeons the ability to attain precise angles
when cutting and dividing tissue in a laparoscopic procedure; the
success and market opportunity of our continuing and new product
development efforts, including the SurgiBot system; the effect on our
business of existing and new regulatory requirements; and other economic
and competitive factors. For a discussion of the most significant risks
and uncertainties associated with TransEnterix's business, please review
our filings with the Securities and Exchange Commission (SEC), including
our Annual Report on Form 10-K for the year ended Dec. 31, 2013; and
subsequent SEC reports. You are cautioned not to place undue reliance on
these forward-looking statements, which are based on our expectations as
of the date of this press release and speak only as of the date of this
press release. We undertake no obligation to publicly update or revise
any forward-looking statement, whether as a result of new information,
future events or otherwise.
Copyright Business Wire 2014