Intuitive Surgical Announces New da Vinci(R) Xi(TM) Surgical System
SUNNYVALE, Calif., April 1, 2014 (GLOBE NEWSWIRE) -- Intuitive Surgical, Inc.
(Nasdaq:ISRG), the global leader in robotic-assisted minimally invasive
surgery, today announced the FDA clearance and U.S. introduction of the da
Vinci Xi Surgical System, a technological leap forward in replacing
large-incision abdominal surgeries (open surgery) with a minimally invasive
The da Vinci Xi System has broader capabilities than prior generations of the
da Vinci System. It can be used across a wide spectrum of minimally invasive
surgical procedures and has been optimized for complex, multi-quadrant
For more than a decade, da Vinci Surgical Systems have provided patients with
a minimally invasive alternative to open surgery that reduces many of the
costs and complications associated with open procedures. Intuitive Surgical
designed the new da Vinci Xi System with the goal of further advancing the
technology used in minimally invasive surgery for complex diseases and
conditions in gynecology, urology, thoracic, cardiac, and general surgery.
"Our goal is to develop technology that enhances surgical performance," said
Gary Guthart, Intuitive Surgical President and Chief Executive Officer. "The
da Vinci Xi System's new overhead architecture means that multi-quadrant
surgery can be performed without repositioning the system, an innovation long
sought by surgeons who perform complex procedures. We strive to provide the
most advanced, least invasive option for surgery, and we are working hard to
make minimally invasive surgery the standard of care."
With the U.S. introduction now underway, Intuitive Surgical will be seeking
regulatory clearances to market the da Vinci Xi System around the world.
Efficient Anatomical Access, Crystal Clear 3D-HD Visualization
By enabling efficient access throughout the abdomen and chest, the da Vinci Xi
System expands upon core da Vinci System features, including 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 a highly magnified view, virtually
extending their eyes and hands into the patient.
Compared to 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
In addition, the da Vinci Xi System is built to be compatible with Intuitive
Surgical's Firefly™ Fluorescence Imaging System. While it is not currently
available, we plan to seek regulatory clearance for use of Firefly Imaging
with the da Vinci Xi System. This technology is currently available as an
option with the da Vinci Si™ model, and it is used to provide the surgeon with
additional visual information in a variety of surgical procedures by enabling
real-time visualization and assessment of vessels, bile ducts and tissue
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 imaging, advanced instruments and anatomical access, as well as
To provide hospitals with choices to match their needs, Intuitive Surgical
will continue to offer the current da Vinci Si System, which addresses a broad
span of procedure complexity, and the da Vinci Si-e™ System, a lower-cost
system suited for less complex surgeries.
For more information about the da Vinci Xi Surgical System, visit
AboutIntuitive Surgical, Inc.
Intuitive Surgical, Inc.(Nasdaq:ISRG), headquartered inSunnyvale, Calif., is
the global leader in robotic-assisted, minimally invasive surgery.Intuitive
Surgicaldevelops, manufactures and markets thedaVinci^®Surgical
System.Intuitive Surgical'smission is to extend the benefits of minimally
invasive surgery to those patients who can and should benefit from it.
About thedaVinci^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
Indications for Use for the da Vinci^® Xi™ Surgical System
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical
System, Model IS4000) is intended to assist in the accurate control of
Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt
and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle
holders, endoscopic retractors, electrocautery and accessories for endoscopic
manipulation of tissue, including grasping, cutting, blunt and sharp
dissection, approximation, ligation, electrocautery, suturing, and delivery
and placement of microwave and cryogenic ablation probes and accessories,
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 environment in accordance with the representative, specific
procedures set forth in the Professional Instructions for Use.
Indications for use for Firefly™ Fluorescence Imaging for the da Vinci Si
The da Vinci^® Fluorescence Imaging Vision System (Firefly™ Fluorescence
Imaging) is intended to provide real-time endoscopic visible and near-infrared
fluorescence imaging. The da Vinci Fluorescence Imaging Vision System enables
surgeons to perform minimally invasive surgery using standard endoscopic
visible light as well as visual assessment of vessels, blood flow and related
tissue perfusion, and at least one of the major extra-hepatic bile ducts
(cystic duct, common bile duct, and common hepatic duct) using near infrared
Fluorescence imaging of biliary ducts with the da Vinci Fluorescence Imaging
Vision System is intended for adjunctive use only in conjunction with standard
of care white light and, when indicated, intraoperative cholangiography. The
device is not intended for standalone use for biliary duct visualization.
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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