TransEnterix Announces Submission of General Surgery Expansion in the US
August 04 2020 - 6:55AM
Business Wire
TransEnterix, Inc. (NYSE American:TRXC), a medical device
company that is digitizing the interface between the surgeon and
the patient to improve minimally invasive surgery, today announced
that it has submitted an indications filing to the FDA to expand
General Surgery usage of the Senhance Surgical System.
“This submission is an important milestone for the continued
application of Senhance in the highest volume and value
procedures,” said Anthony Fernando, president and chief executive
officer at TransEnterix. “General Surgery is by far the largest
procedural area in minimally invasive abdominal surgery, and we are
pleased to have submitted significant additional clinical data to
expand the procedures for which surgeons can utilize the benefit of
Senhance.”
The Senhance System is the first and only digital laparoscopic
surgical platform designed to maintain laparoscopic MIS standards
while providing digital benefits such as haptic feedback, robotic
precision, comfortable ergonomics, advanced instrumentation
including, 3 mm mini-laparoscopic instruments, eye sensing camera
control and reusable standard instruments to help maintain
per-procedure costs similar to traditional laparoscopy. The
Senhance System is also the first machine-vision system in robotic
surgery which is powered by the new intelligent Surgical Unit (ISU)
that enables augmented intelligence in surgery.
Current Senhance US Indication for Use
The Senhance® Surgical System is intended to assist in the
accurate control of laparoscopic instruments for visualization and
endoscopic manipulation of tissue including grasping, cutting,
blunt and sharp dissection, approximation, ligation,
electrocautery, suturing, mobilization and retraction. The Senhance
Surgical System is intended for use in laparoscopic gynecological
surgery, colorectal surgery, cholecystectomy, and inguinal hernia
repair. The system is indicated for adult use. It is intended for
use by trained physicians in an operating room environment in
accordance with the Instructions for Use.
About TransEnterix
At TransEnterix, Inc., we are digitizing the interface between
the surgeon and the patient to improve minimally invasive surgery
(MIS) through a new category of care called Digital Laparoscopy.
Digitizing the interface enables the use of advanced capabilities
like augmented intelligence, connectivity and robotics in
laparoscopy, and allows us to address the current clinical,
cognitive and economic shortcomings in surgery. The system features
the first machine vision system for use in robotic surgery which is
powered by the new intelligent Surgical Unit (ISU) that enables
augmented intelligence in surgery. The Senhance®️ Surgical System
brings the benefits of Digital Laparoscopy to patients around the
world while staying true to the principles of value-based
healthcare. Learn more about Digital Laparoscopy with the Senhance
Surgical System here: https://Senhance.com/. Now available for sale
in the US, the EU, Japan, and select other countries. For a
complete list of indications for use, please visit:
https://www.transenterix.com/indications-for-use/.
Forward-Looking Statements
This press release includes statements relating to the Senhance
System and the Company’s submission of an indication filing to the
FDA to expand General Surgery usage of the Senhance Surgical
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 and include whether the FDA
will clear the filing to expand the General Surgery indication
usage of the Senhance Surgical System. For a discussion of the
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 December 31, 2019, filed with the SEC on March 16, 2020
and our other filings we make with the SEC. 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 origination 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200804005239/en/
For TransEnterix, Inc. Investor Contact: Mark Klausner, +1
443-213-0501 invest@transenterix.com
or
Media Contact: Terri Clevenger, +1 203-682-8297
terri.clevenger@icrinc.com
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