Hugo™ robotic-assisted surgery system
regulatory approval in Japan
provides access to third largest robotics market in the world while
general surgery approval in the EU and Canada open fast-growing hernia
specialty
DUBLIN, Oct. 19,
2022 /PRNewswire/
-- Medtronic plc (NYSE:MDT), a global healthcare
technology leader, has announced three significant global
market-entrance and indication expansion approvals for its Hugo™
robotic-assisted surgery (RAS) system.
The approvals include:
- Conformité Européenne (CE) Mark clearance for general
surgery indication;
- Health Canada licence
for general laparoscopic surgery indication; and
- Ministry of Health, Labor, and Welfare (MHLW) approval
for urologic surgical and gynecologic laparoscopic indications in
Japan.
The new system approvals and indications set the stage for
significant access across Europe,
North America, and Asia — extending the benefits of minimally
invasive surgery to new global audiences.
As a form of minimally invasive surgery, robotic-assisted
procedures offer patients fewer complications, shorter hospital
stays, and faster return to normal
activities.2-4,†
Together, general surgery, urology, and gynecology account
for more than 80% of all RAS procedures performed
globally.1 General surgery is the fastest growing
segment within robotic surgery. It encompasses several different
surgical specialties including hernia repair, the fourth most
common surgery performed globally.1 Japan is the third-largest RAS market in the
world today.1
"Receiving these important approvals paves the way for our
expansion into key robotic markets," said Mike Marinaro, senior vice president and
president, Surgical Robotics, which is part of the Medical Surgical
Portfolio at Medtronic. "The Hugo RAS system was designed to
address the barriers to robotic surgery adoption, and these
approvals are significant steps in bringing the benefits of
minimally invasive surgery to more patients in more places around
the world."
Medtronic's expansion into surgical robotics represents a
significant growth opportunity for the company and builds on its
more than 60 years of experience in surgical and healthcare
innovation in partnership with clinicians around the
world.
The Hugo RAS system, combined with Touch Surgery™
Enterprise, offers a smart, digitally enabled surgical experience,
and is already being used in general surgery procedures at
hospitals in the Asia Pacific and
Latin America regions. The
procedures range from common to more complex and include
cholecystectomy, inguinal hernia repair, gastric bypass, and lower
anterior resection.
A modular system, Hugo combines wristed instruments, 3D
visualization, and Medtronic's Touch Surgery Enterprise, a
cloud-based surgical video capture and management solution, with
dedicated support teams specializing in robotics program
optimization, service, and training. Touch Surgery Enterprise is a
first-of-its-kind AI-powered platform that makes sharing surgical
video simple and provides surgeons with a powerful new training
tool.‡
"These regulatory approvals are a major step in expanding
the benefits of minimally invasive surgery to patients around the
world. We truly believe that AI-assisted robotic surgery will
transform the operating room," said Dr. Carla Peron, chief medical officer, Surgical
Robotics at Medtronic. "Our team is thrilled to begin partnering
with more surgeons and customers to help build and grow their
robotic surgery programs in this hugely important area of
healthcare."
The Hugo RAS system is commercially available in certain
geographies. Regulatory requirements and status in individual
countries and regions will determine market availability of the
Hugo RAS system and approved indications. In the U.S., the Hugo RAS
system is an investigational device not for sale.
For more information,
visit medtronic.com/hugo.
†Compared to open
surgery.
‡Touch Surgery™ Enterprise is not intended
to direct surgery, or aid in diagnosis or treatment of a disease or
condition.
- Based on internal estimates and Medtronic report, FY20
market model: procedural volume data.
- Fitch K, Engel T, Bochner A. Cost differences between open and
minimally invasive surgery. Managed
Care. 2015;24(9):40–48.
- 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.
- 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.
About Medtronic
Bold thinking.
Bolder actions. We are Medtronic. Medtronic plc, headquartered in
Dublin, Ireland, is the leading
global healthcare technology company that boldly attacks the most
challenging health problems facing humanity by searching out and
finding solutions. Our Mission — to alleviate pain, restore health,
and extend life — unites a global team of 90,000+ passionate people
across 150 countries. Our technologies and therapies treat 70
health conditions and include cardiac devices, surgical robotics,
insulin pumps, surgical tools, patient monitoring systems, and
more. Powered by our diverse knowledge, insatiable curiosity, and
desire to help all those who need it, we deliver innovative
technologies that transform the lives of two people every second,
every hour, every day. Expect more from us as we empower
insight-driven care, experiences that put people first, and better
outcomes for our world. In everything we do, we are engineering the
extraordinary. For more information on Medtronic (NYSE:MDT), visit
www.Medtronic.com and follow @Medtronic on Twitter and
LinkedIn.
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.
Contacts:
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SOURCE Medtronic plc