Intuitive Surgical Receives CE Mark for the da Vinci(R) Xi(TM) Surgical System
SUNNYVALE, Calif., June 25, 2014 (GLOBE NEWSWIRE) -- Intuitive Surgical, Inc.
(Nasdaq:ISRG), the global leader in robotic-assisted minimally invasive
surgery, today announced it has received a CE Mark for its da Vinci Xi
Surgical System. Achieving this milestone allows the company to market the Xi
System in Europe and other countries that require the CE Mark. In April, the
da Vinci Xi System received clearance from the U.S. Food and Drug
Administration (FDA) and is now commercialized in the United States.
The da Vinci Xi System is intended to be a technological leap forward in
replacing large-incision open surgeries with a minimally invasive approach.
Intuitive Surgical designed the new da Vinci Xi System to optimize
ease-of-use. For example, the da Vinci Xi System can help simplify procedures
requiring access to multiple areas of the pelvis, abdomen or chest. For more
than a decade, da Vinci Surgical Systems have enabled surgeons to offer a
minimally invasive alternative to open surgery that aims to reduce many of the
costs and complications associated with open procedures.
"We are pleased to bring the da Vinci Xi System to market in Europe and other
countries that rely on the CE Mark for marketing authorization," said Henry
Charlton, Intuitive Surgical Vice President, Sales and Marketing, Europe,
Middle East, India and Africa (EMEIA), Latin America, Canada and Australia.
"With the CE Mark, we're expanding our customer base that has access to this
exciting new technology. The da Vinci Xi System represents the most advanced
option available to date as we strive to make minimally invasive surgery the
global standard of care."
With the U.S. and European introductions underway, Intuitive Surgical is
seeking additional regulatory clearances to market the da Vinci Xi System
around the world. These include clearances for advanced technologies such as
vessel sealing, stapling and fluorescence imaging, which are designed to
enhance the capabilities of the da Vinci Xi System. This month, Intuitive
Surgical received the first of these clearances from the FDA to market the
EndoWrist® One™ Vessel Sealer instrument for the da Vinci Xi System in the
Efficient Anatomical Access, Crystal Clear 3D-HD Visualization
By enabling efficient access throughout the pelvis, abdomen and chest, the da
Vinci Xi System expands upon the core da Vinci System features, which include
wristed instruments, 3D-HD visualization, intuitive motion and an ergonomic
design. As with all da Vinci Surgical Systems, the da Vinci Xi System's
immersive 3D-HD vision system provides surgeons with a highly magnified view,
virtually extending their eyes and hands into the patient.
Compared with prior da Vinci Systems, the da Vinci Xi System's key features
*A new overhead instrument arm architecture designed to facilitate
anatomical access from virtually any position.
*A new endoscope digital architecture that creates a simpler, more compact
design with improved visual definition and clarity.
*An ability to attach the endoscope to any arm, providing flexibility for
visualizing the surgical site.
*Smaller, thinner arms with newly designed joints that offer a greater
range of motion than ever before.
*Longer instrument shafts designed to give surgeons greater operative
A System Designed For the Future
The da Vinci Xi System is an expandable technology platform that is designed
to accommodate and seamlessly integrate a range of current technologies in
areas such as fluorescence imaging, advanced instruments and anatomical
access, as well as future innovations.
For more information about the da Vinci Xi Surgical System, visit
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, Calif., is
the global leader in robotic-assisted, minimally invasive surgery. Intuitive
Surgical develops, manufactures and markets the da Vinci® ^ Surgical System.
Intuitive Surgical's mission is to extend the benefits of minimally invasive
surgery to those patients who can and should benefit from it.
About the daVinci^Surgical System
ThedaVinciSurgical System is a surgical platform designed to enable complex
surgery using a minimally invasive approach. ThedaVinciSurgical System
consists of an ergonomic surgeon console or consoles, a patient-side cart with
three or four interactive arms, a high-performance vision system and
proprietaryEndoWrist®instruments. Powered by state-of-the-art technology,
thedaVinciSurgical System is designed to scale, filter and seamlessly
translate the surgeon's hand movements into more precise movements of
theEndoWristinstruments. The net result is an intuitive interface with
advanced surgical capabilities. By providing surgeons with superior
visualization, enhanced dexterity, greater precision and ergonomic comfort
compared to other surgical approaches, thedaVinciSurgical System makes it
possible for skilled surgeons to perform minimally invasive procedures
involving complex dissection or reconstruction.
All surgery presents risk, including da Vinci Surgery and other minimally
invasive procedures. Serious complications may occur in any surgery, up to and
including death. Examples of serious and life-threatening complications, which
may require hospitalization, include injury to tissues or organs, bleeding,
infection, and internal scarring that can cause long-lasting dysfunction or
pain. For more complete information on risks, considerations, safety, and
indications for use, please refer to www.davincisurgery.com. For more
information about clinical evidence related todaVinciSurgery, please
The da Vinci Xi System is CE Marked in the EU for the following Intended Use:
TheIntuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical
System Model IS4000) is intended to assist in the accurate control
ofIntuitive Surgical Endoscopic Instruments during urologic surgical
procedures, general laparoscopic surgical procedures, gynecologic laparoscopic
surgical procedures, general thoracoscopic surgical procedures and
thoracoscopically assisted cardiotomy 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. It is intended to be used by trained physicians in an operating room
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 Xi System around the
world. 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, 2013, 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.
CONTACT: Intuitive Surgical Corporate Communications
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