UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
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Date of Report: July 12, 2004
(Date of earliest event reported)
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Intuitive Surgical, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of incorporation)
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000-30713
(Commission File Number)
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77-0416458
(IRS Employer Indentification Number)
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950 Kifer Road Sunnyvale, California
(Address of principal executive offices)
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94086
(Zip Code)
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Registrant's telephone number, including area code: 408-523-2100
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Item 5. Other Events and Regulation FD Disclosure
On July 8, 2004, Intuitive Surgical issued a press release announcing that its da Vinci(R) Surgical System received FDA clearance for cardiac revascularization. A copy of the press release is attached hereto as Exhibit 99.1.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned hereunto duly authorized.
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Dated: July 12, 2004
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INTUITIVE SURGICAL, INC.
By: /s/ Lonnie M. Smith
Lonnie M. Smith
Chief Executive Officer
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Exhibit
99.1 Press Release of Intuitive Surgical, Inc. dated July 08, 2004
Intuitive Surgical Receives FDA Clearance for Cardiac Revascularization
SUNNYVALE, CA -- July 8, 2004 -- Intuitive Surgical, Inc. (NASDAQ: ISRG), the
industry leader in operative surgical robotics, today announced that FDA
clearance has now been granted for use of the da Vinci® Surgical System
to perform coronary anastomosis during cardiac revascularization. This
clearance follows the submission of data from a multi-center clinical trial
involving use of the da Vinci Surgical System to perform internal mammary
artery anastomosis to the left anterior descending coronary artery. This
indication broadens the use of the da Vinci Surgical System, allowing
surgeons in the United States to perform coronary artery bypass surgery
with small incisions.
Commenting on the clearance, Lonnie Smith President and CEO of Intuitive
Surgical said, "We are pleased with the FDA's most recent cardiac
clearance for the da Vinci Surgical System which adds cardiac
revascularization to the intra-cardiac procedures previously cleared by the
agency. U.S. surgeons can now use the da Vinci Surgical System to perform
minimally invasive cardiac revascularization offering their patients an
attractive alternative to traditional cardiac surgery.
Michael Argenziano, M.D., Assistant Professor of Surgery at the Columbia
University College of Physicians and Surgeons, and Director of Minimally
Invasive Cardiac Surgery and Arrhythmia Surgery at New York-Presbyterian
Hospital, principal investigator for the study said, "With the current FDA
clearance, which is based on data obtained in our multi-center trial of
endoscopic coronary artery bypass grafting, the da Vinci Surgical System is
now available to facilitate a broad range of minimally invasive cardiac
surgery, from intracardiac procedures such as valve repair to epicardial
procedures such as cardiac revascularization. I am confident that the da
Vinci System will become an important part of every cardiac surgeon's
technical arsenal, ultimately improving the way we treat patients suffering
from cardiovascular disease."
Douglas Murphy, M.D., Chief of Cardiac Surgery at St. Joseph's Hospital of
Atlanta, and an investigator in the trial said, "We can now perform robotic
cardiac revascularization in its entirety, from internal mammary artery
harvest to performing the critical anastomosis with unparalleled precision.
This clearance provides better surgical options for our patients while
advancing the frontiers of minimally invasive cardiac surgery."
About Intuitive's Products:
The da Vinci Surgical System consists of a surgeon's viewing and control
console having an integrated, high-performance InSite® 3-D vision system,
a patient-side cart consisting of three or four robotic arms that position
and precisely maneuver endoscopic instruments and an endoscope, and a
variety of articulating EndoWrist® Instruments. By integrating
computer-enhanced technology with surgeons' technical skills, Intuitive
believes that its system enables surgeons to perform better surgery in a
manner never before experienced. The da Vinci Surgical System seamlessly
and directly translates the surgeon's natural hand, wrist and finger
movements on instrument controls at the surgeon's console outside the
patient's body into corresponding micro-movements of the instrument tips
positioned inside the patient through small puncture incisions, or ports.
The Aesop® Endoscope Positioner is a voice-activated robotic arm that
automates the critical task of endoscope positioning, providing the surgeon
with direct control over a smooth, precise and stable view of the internal
surgical field.
The Hermes® Control Center is a centralized system designed to voice
control a series of networked "smart" medical devices.
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
the following: timing and success of product development and market
acceptance of developed products; regulatory approvals, clearances and
restrictions; guidelines and recommendations in the health care and patient
communities; intellectual property positions and litigation; competition in
the medical device industry and in the specific markets of surgery in which
Intuitive Surgical operates; and unanticipated manufacturing disruptions,
delays in regulatory approvals of new manufacturing facilities or the
inability to meet demand for products. Words such as "estimate," "project,"
"plan," "intend," "expect," "anticipate," "believe" and similar 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 to reflect events or circumstances after the date of this press
release or to reflect the occurrence of unanticipated events.
Intuitive®, da Vinci®, InSite®, EndoWrist®, Hermes®, and Aesop®
are registered trademarks of Intuitive Surgical, Inc.
Contacts:
Ben Gong
408-523-2175
Sarah Norton
408-523-2161