U.S. FDA Clears da Vinci SP for Certain Transoral Otolaryngology Procedures
March 15 2019 - 12:36PM
Intuitive (Nasdaq:ISRG), a global technology leader in minimally
invasive care and the pioneer of robotic-assisted surgery, today
announced it has received clearance for the da Vinci SP®
surgical system for use in certain transoral otolaryngology
procedures in adults. The FDA cleared the single port approach for
lateral oropharyngectomy procedures (commonly referred to as
radical tonsillectomy) and tongue base resection.
"Today’s FDA clearance means surgeons can utilize da Vinci SP
robotic-assisted surgery to conduct radical tonsillectomy and
tongue base resection transorally,” said Gary
Guthart, Intuitive CEO. “Our single port innovation is part of
our commitment to helping surgeons and their teams improve patient
outcomes, decrease variability in surgery, and improve the patient
and surgical team experience.”
The da Vinci SP system provides surgeons with robotic-assisted
technology designed for deep and narrow access to tissue in the
body. The ability to enter the body through a single, small
incision or through a natural orifice can provide a minimally
invasive experience for complex procedures.
“Intuitive’s da Vinci SP complements our other systems by
enabling surgeons to access narrow workspaces while maintaining
high quality vision, precision, and control that surgeons have come
to trust from da Vinci systems,” said Guthart.
The da Vinci SP system includes three, multi-jointed, wristed
instruments and a fully wristed 3D HD camera. The instruments and
the camera all emerge through a single cannula and are properly
triangulated around the target anatomy at the distal tip to avoid
external instrument collisions that can occur in narrow surgical
workspaces. The system enables flexible port placement and
excellent internal and external range of motion (e.g., 360-degrees
of anatomical access) through the single SP arm. Surgeons control
the fully articulating instruments and the camera on the da Vinci
SP system, which uses the same surgeon console as the da Vinci X®
and Xi™ systems.
Transoral otolaryngology procedures represent the second
category of procedures the FDA has cleared for the da Vinci SP
surgical system; the FDA cleared the da Vinci SP system for urology
procedures in May 2018. Since the initial clearance, Intuitive has
shipped 15 da Vinci SP systems in 2018. With this additional
indication, Intuitive plans to continue with its measured
introduction of the da Vinci SP system in 2019.
About Intuitive Surgical, Inc.
Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is
a global technology leader in minimally invasive care and the
pioneer of robotic-assisted surgery. At Intuitive, we believe that
minimally invasive care is life-enhancing care. Through ingenuity
and intelligent technology, we expand the potential of physicians
to heal without constraints.
Intuitive brings more than two decades of leadership in
robotic-assisted surgical technology and solutions to its
offerings, and develops, manufactures and markets the da Vinci®
surgical system and the Ion™ endoluminal system.
Surgical Risks
For Important Safety Information, indications for use, risks,
full cautions and warnings, please refer to
www.intuitive.com/safety.
Forward-Looking Statement
This press release contains forward-looking statements,
including statements regarding the da Vinci SP Surgical System and
its potential utility. These forward-looking statements are based
on current expectations and estimates 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, but not limited
to, the following: the impact of global and regional economic and
credit market conditions on healthcare spending; healthcare reform
legislation in the United States and its impact on
hospital spending, reimbursement and fees levied on certain medical
device revenues; changes in hospital admissions and actions by
payers to limit or manage surgical procedures; the timing and
success of product development and market acceptance of developed
products, including, but not limited to, the recently cleared Ion
endoluminal system, da Vinci SP Surgical System and 3rd generation
stapling platform; the results of any collaborations, in-licensing
arrangements, joint ventures, strategic alliances or partnerships;
procedure counts; regulatory approvals, clearances and restrictions
or any dispute that may occur with any regulatory body; guidelines
and recommendations in the healthcare and patient communities;
intellectual property positions and litigation; competition in the
medical device industry and in the specific markets of surgery in
which the company operates; unanticipated manufacturing disruptions
or the inability to meet demand for products; the results of legal
proceedings to which the company is or may become a party; product
liability and other litigation claims; adverse publicity regarding
the company and the safety of the company’s products and adequacy
of training; the company’s ability to expand into foreign markets;
the impact of changes to tax legislation, guidance, and
interpretations; and other risk factors under the heading “Risk
Factors” in the company’s annual report on Form 10-K for the year
ended December 31, 2018, as updated by the company’s 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. The company undertakes 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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