TransEnterix Announces CE Mark Approval for Pediatric Indication for Senhance Surgical System
February 12 2020 - 6:50AM
Business Wire
TransEnterix is First to Offer Robotic 3 mm
Microlaparoscopic Surgery for Pediatric Patients
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 the Company received CE Mark approval for an expanded
indication to treat pediatric patients above 10kg (approximately 22
lbs) with the Senhance® System.
“Given the size of the patients, pediatric surgery seeks to use
the smallest instruments and scopes possible to minimize
invasiveness, yet it is critical to maintain a high degree of
precision,” said Anthony Fernando, president and chief executive
officer of TransEnterix. “The Senhance System is designed to
maximize control of instruments as small as 3 mm and be compatible
with small scopes while also retaining the sense of touch through
haptic feedback. This makes our technology uniquely positioned to
meet the requirements of pediatric surgeons, and we look forward to
working closely with leading European hospitals to serve the needs
of their pediatric patients.”
“The ability to use 3 mm microlaparoscopic instruments on a
robotic platform is very exciting and is a large step forward in
treating pediatric patients,” said Prof. Dr. Wim van Gemert,
chairman of the department of pediatric surgery, Maastricht
University Medical Center+ in the Netherlands. “Especially in
younger patients, smaller ports and instruments are critically
important in achieving the best outcomes given the body size
constraints in these patients.”
The Senhance® Surgical System is the first and only digital
laparoscopic platform designed to maintain laparoscopic MIS
standards while providing digital benefits such as haptic feedback,
robotic precision, eye-sensing camera control, comfortable
ergonomics, advanced instrumentation including, 3 mm
microlaparoscopic instruments, eye-sensing camera control and
reusable standard instruments to help maintaining per-procedure
costs similar to traditional laparoscopy.
Senhance European Indication for Use
The Senhance® Surgical System has received a CE Mark according
to the Medical Device Directive and is intended to be used for
laparoscopic surgery in the abdomen, pelvis and limited uses in the
thoracic cavity excluding the heart and greater vessels. The system
is indicated for adult and pediatric use in CE marked
territories.
About TransEnterix
TransEnterix is a medical device company that is digitizing the
interface between the surgeon and the patient to improve minimally
invasive surgery by addressing the clinical and economic challenges
associated with current laparoscopic and robotic options in today's
value-based healthcare environment. The Company is focused on the
commercialization of the Senhance Surgical System, which digitizes
laparoscopic minimally invasive surgery. The system allows for
robotic precision, haptic feedback, surgeon camera control via eye
sensing and improved ergonomics while offering responsible
economics. The Senhance Surgical System is available for sale in
the US, the EU, Japan and select other countries. For more
information, visit www.transenterix.com.
Forward-Looking Statements
This press release includes statements relating to the Senhance
System and the expansion of indications to include pediatric
applications in CE marked territories. 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,
including whether the indication expansion to treat pediatric
patients will broaden our Senhance footprint in CE countries and
whether the Senhance System technology is uniquely positioned to
meet the requirement of pediatric surgeons. 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, 2018, filed with the SEC on February 27,
2019 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/20200212005171/en/
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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