Multiple Hospitals Across Europe Set to be the First to
Install Hugo™ RAS System and Expand the Benefits of
Robotic-Assisted Surgery to Their Patients
DUBLIN, Oct. 11, 2021 /CNW/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced it has received CE (Conformité Européenne) Mark for
the Hugo™ robotic-assisted surgery (RAS) system, authorizing
the sale of the system in Europe.
CE Mark approval is for urologic and gynecologic procedures, which
make up about half of all robotic procedures performed today.
"This day has been a long time coming, not just for Medtronic,
but for the surgeons and hospital leaders who have partnered with
us on this journey to bring the benefits of robotic-assisted
surgery to more patients around the world. We know our solution is
more meaningful because of their insights," said Megan Rosengarten, president of the Surgical
Robotics business, which is part of the Medical Surgical Portfolio
at Medtronic. "With the Hugo RAS system in our European customers'
hands and our dedicated team by their side, together we will
redefine what is possible in robotic-assisted surgery."
The Hugo RAS system was designed to address the historic cost
and utilization barriers that have stifled robotic surgery adoption
for two decades. Globally, about 3% of surgeries are performed
robotically,1 despite offering patients the benefits of
minimally invasive surgery — fewer complications, shorter hospital
stays, and faster return to normal activities.2–4,† In
Western Europe, about 2% of
procedures are done robotically while the majority, approximately
65%, are open surgery.1 The remainder are traditional
minimally invasive surgery.1
"Robotics and artificial intelligence are the undeniable future
of healthcare, with incredible potential to not only advance
patient care, but increase access to these benefits," said Rob ten
Hoedt, executive vice president and president of the Europe, Middle
East, and Africa (EMEA)
region at Medtronic. "The Hugo RAS system builds on our leadership
in minimally invasive surgery, and we're thrilled to provide
hospitals across Europe a
robotic-assisted surgery system that is thoughtfully designed to
meet their needs today and tomorrow. We've had strong interest from
leading surgical centers across Europe and expect to move quickly with
multiple installations in several countries."
These hospitals will be the first in Europe to join Medtronic's Partners in
Possibility Program, a group of pioneering institutions that will
be among the first in the world to use the Hugo RAS system and
participate in the global patient registry. Clinicians from these
hospitals will participate in hands-on training at Medtronic
Surgical Robotics Experience Centers, including two flagship sites
operated in partnership with the ORSI Academy in Ghent,
Belgium, and IRCAD in Strasbourg, France.
CE Mark approval comes on the heels of major milestones in the
Hugo RAS system global launch, including the first urological and
gynecological procedures, which took place in Latin America and India and marked the start of the Hugo RAS
system global patient registry. A modular, multi-quadrant platform
designed for a broad range of surgical procedures, the Hugo RAS
system combines wristed instruments, 3D visualization, and a
cloud-based surgical video capture option in Touch Surgery™
Enterprise with dedicated support teams specializing in robotics
program optimization, service, and training.
The Hugo RAS system is commercially available in certain
geographies. Regulatory requirements of individual countries and
regions will determine approval, clearance, or market availability.
In the EU, the Hugo RAS system is CE marked. In the U.S., the Hugo
RAS system is an investigational device not for sale. Touch Surgery
Enterprise is not intended to direct surgery, or aid in diagnosis
or treatment of a disease or condition.
For more information, visit medtronic.com/hugo.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies — alleviating pain, restoring health, and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
†Compared to open
surgery.
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1.
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Based on internal
estimates and Medtronic report, FY20 market model: procedural
volume data.
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2.
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Fitch K, Engel T,
Bochner A. Cost differences between open and minimally invasive
surgery. Managed Care. 2015 Sep;24(9):40–48.
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3.
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Tiwari MM, Reynoso
JF, High R, Tsang AW, Oleynikov D. Safety, efficacy, and cost
effectiveness of common laparoscopic procedures. Surg
Endosc. 2011;25(4):1127-1135.
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4.
|
Roumm AR, Pizzi L,
Goldfarb NI, Cohn H. Minimally invasive: minimally reimbursed? An
examination of six laparoscopic surgical procedures. Surg
Innov. 2005;12(3):261–287.
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Contacts:
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Gary
Jeanfaivre
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Ryan
Weispfenning
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Public
Relations
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Investor
Relations
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+1-203-833-2104
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+1-763-505-4626
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SOURCE Medtronic plc