Intuitive Surgical Announces FDA Clearance of da Vinci(R) Sp(TM) Surgical System

Intuitive Surgical Announces FDA Clearance of da Vinci(R) Sp(TM) Surgical
System

SUNNYVALE, Calif., April 22, 2014 (GLOBE NEWSWIRE) -- Intuitive Surgical, Inc.
(Nasdaq:ISRG), the global leader in robotic-assisted minimally invasive
surgery, today announced it has received FDA 510(k) clearance for the da Vinci
Sp Surgical System, which is designed to expand the Company's single-incision
product offering. This initial clearance is specific to urologic surgical
procedures that are appropriate for a single port approach.

"Our development of this single-port technology represents our foundational
commitment to advancing tools for minimally invasive surgery," said Gary
Guthart, Intuitive Surgical's President and CEO.

da Vinci Sp technology is a dedicated single-port innovation designed to
deliver an articulating 3D HD camera and three fully articulating instruments
through a single 25 mm cannula. The fully wristed EndoWrist® Sp Instruments
have two more degrees of freedom than the da Vinci Single-Site® Instruments,
which are not wristed and are used in single port surgeries. The surgeon
controls the instruments and endoscope while seated at the da Vinci Surgical
System console.

The Company does not intend to commercialize the da Vinci Sp technology until
the current technology is engineered to be fully compatible with the newly
released da Vinci Xi™ Surgical System, currently projected for the second half
of 2015. This will require product refinements, supply chain optimization and
additional regulatory clearances.

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 da Vinci® Surgical Systems.
Intuitive Surgical's mission is to extend the benefits of minimally invasive
surgery to those patients who can and should benefit from it. For more
information, visit intuitivesurgical.com.

Indications for Use for the da Vinci Sp Surgical System and EndoWrist Sp
Instruments

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Sp
Surgical System, Model SP999) is intended to assist in the accurate control of
Intuitive Surgical EndoWrist Sp Instruments during urologic surgical
procedures that are appropriate for a single port approach. The system is
indicated for adult use. It is intended for use by trained physicians in an
operating room environment in accordance with the representative, specific
procedures set forth in the Professional Instructions for Use.

Intuitive Surgical EndoWrist Sp Instruments are controlled by the da Vinci Sp
Surgical System, Model SP999, and include flexible endoscopes, blunt and sharp
endoscopic dissectors, scissors, 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, and suturing through a single
incision laparoscopic approach. The system is indicated for urologic surgical
procedures that are appropriate for a single port approach. The system is
indicated for adult use. It is intended for use by trained physicians in an
operating room environment in accordance with the representative, specific
procedures set forth in the Professional Instructions for Use.

The safety and effectiveness of this device for use in the performance of
general laparoscopic surgery procedures have not been established. This device
is only intended to be used for single port urological procedures with the da
Vinci EndoWrist Sp Instruments and the da Vinci Sp Surgical System (SP999).

Surgical Risks

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.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. 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
         408-523-7337
         corp.comm@intusurg.com
 
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