New da Vinci X(TM) Surgical System provides lower-cost,
robotic-assisted surgical option for hospitals, surgeons
AUBONNE, Switzerland, April 26, 2017
(GLOBE NEWSWIRE) -- Intuitive Surgical, a global technology leader
in robotic-assisted, minimally invasive surgery, announced today
that its new da Vinci X Surgical
System received CE Mark approval in Europe. The da Vinci X System will provide surgeons and
hospitals with access to some of the most advanced robotic-assisted
surgery technology at a lower cost.
A photo accompanying this announcement is
available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/0c20bf18-fcc5-4d29-8bab-4ada1ab29eae
The launch of the da Vinci
X System underscores Intuitive's commitment to meeting
customers' needs with a strong value-oriented portfolio of
cost-appropriate technologies and an array of financing
options.
"Over the past 21 years, Intuitive Surgical
pioneered robotic-assisted surgery and we continue to lead the way
in developing and bringing to market innovative technologies,
outcomes-focused products and value-oriented solutions," said Dr.
Gary Guthart, CEO of Intuitive Surgical. "Our surgeon, hospital and
healthcare customers around the world told us that robotic-assisted
surgery matters for their programs and their patients while
underscoring the importance of providing choice from a clinical,
technological and cost standpoint. The da
Vinci X product offering provides a lower-cost solution
to meet the needs of customers who want a choice in price points,
while offering access to many of our recent innovations."
The da Vinci
X System offers surgeons and hospitals access to
Intuitive's portfolio of advanced, innovative robotic-assisted
surgical technologies - and its full ecosystem of programs,
support, services, and solutions -at a lower price. The
System uses the same vision cart and surgeon consoles that are
found on our flagship product, the da Vinci
Xi® System,
enabling our customers the option of adding advanced capabilities,
and providing a pathway for upgrading should they choose to do so
as their practice and needs grow.
The da Vinci
X System enables optimized, focused-quadrant surgery
including for procedures like prostatectomy, partial nephrectomy,
hernia repair, benign hysterectomy and sacrocolpopexy, among
others. The System features flexible port placement and
state-of-the-art 3D digital optics, while incorporating the same
advanced instruments and accessories as Intuitive's flagship
system. The new system drives operational efficiencies through
set-up technology that uses voice and laser guidance, drape design
that simplifies surgery prep, and a lightweight, fully integrated
endoscope.
"The da Vinci
X System is a value-oriented, highly capable offering
that meets - and responds to - our customers' economic and clinical
needs," said Damien Desmedt, General Manager of Intuitive Surgical
in the United Kingdom, Ireland, and Nordic countries. "In the
countries we serve around the globe, we know that customers have
different needs and wants, and we strive to provide an array of
choices to meet their needs today and in the future.
The da Vinci X System helps us to continue to do this."
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. (Nasdaq:ISRG),
headquartered in Sunnyvale, Calif., is a global technology leader
in robotic-assisted, minimally invasive surgery. Intuitive Surgical
develops, manufactures and markets the da
Vinci Surgical System.
About the da
Vinci Surgical System
There are several models of the da Vinci Surgical System. The da Vinci Surgical Systems are designed to help
surgeons perform minimally invasive surgery. da Vinci Systems are not programmed to perform
surgery on their own. Instead, the procedure is performed entirely
by a surgeon who controls the system. da
Vinci Systems offer surgeons high-definition 3D vision, a
magnified view, and robotic and computer assistance. They use
specialized instrumentation, including a miniaturized surgical
camera and wristed instruments (i.e., scissors, scalpels and
forceps) that are designed to help with precise dissection and
reconstruction deep inside the body.
Intended Use
The Intuitive Surgical Endoscopic Instrument
Control System (da Vinci X Surgical
System Model IS4200) is intended to assist in the accurate control
of Intuitive Surgical Endoscopic Instruments during urologic
surgical procedures, general laparoscopic surgical procedures,
gynecologic laparoscopic surgical procedures, general thoracoscopic
surgical procedures, thoracoscopically-assisted cardiotomy
procedures, and trans-oral otolaryngology surgical procedures
restricted to benign tumors and malignant tumors classified as T1
and T2, and for benign base of tongue resection procedures. The
System can also be employed with adjunctive mediastinotomy to
perform coronary anastomosis during cardiac
revascularization. The System is indicated for adult and
pediatric use (except for trans-oral otolaryngology surgical
procedures). It is intended to be used by trained physicians
in an operating room environment.
The da Vinci
X Surgical System is a class 2b CE 0543 marked medical
device under the European Medical Devices Directive (93/42/EEC)
manufactured by Intuitive Surgical, Inc. Refer to the
Instructions For Use before use.
Forward Looking Statement
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements regarding regulatory
clearances to market the da Vinci
X System in the US. These forward-looking statements are
necessarily estimates reflecting the best judgment of our
management and involve a number of risks and uncertainties that
could cause actual results to differ materially from those
suggested by the forward-looking statements. These forward-looking
statements should, therefore, be considered in light of various
important factors, including those under the heading "Risk Factors"
in our annual report on Form 10-K for the year ended December
31, 2016, as updated from time to time by our quarterly reports on
Form 10-Q and our other filings with the Securities and
Exchange Commission. Statements using words such as "estimates,"
"projects," "believes," "anticipates," "plans," "expects,"
"intends," "may," "will," "could," "should," "would," "targeted"
and similar words and expressions are intended to identify
forward-looking statements. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date of this press release. We undertake no obligation to
publicly update or release any revisions to these forward-looking
statements, except as required by law.
© 2017 Intuitive Surgical, Inc. All rights
reserved. Product names are trademarks or registered trademarks of
their respective holders.
PN1035581rA EU 4/2017
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