The Symplicity™ blood
pressure procedure offers patients a new adjunct approach to
lowering blood pressure
Approval is the culmination of ten years of
clinical research and development of the Medtronic renal
denervation technology
DUBLIN, Nov. 17, 2023 /PRNewswire/ -- Medtronic plc
(NYSE: MDT), a global leader in healthcare technology, today
announced that the United States Food and Drug Administration (FDA)
has approved the Symplicity Spyral™ renal denervation
(RDN) system, also known as the Symplicity™ blood
pressure procedure, for the treatment of hypertension. With this
approval, Medtronic will immediately begin commercialization.
Hypertension, or high blood pressure, is the leading modifiable
cause of heart attack, stroke, and death, and its prevalence is
notably worse in underserved U.S. populations. Despite available
medications and lifestyle interventions, control rates remain low.
These challenges speak to the possibility that patients may benefit
from an adjunctive treatment option to better manage their blood
pressure.
"Medtronic has always believed in the potential of this therapy.
We partnered closely with leading experts in our clinical community
who could help us in our journey to get this technology to the
people who need it most," said Jason
Weidman, senior vice president and president of the Coronary
and Renal Denervation business within the Cardiovascular Portfolio
at Medtronic. "It was the promise of this therapy that enabled
Medtronic to keep going, even when others exited the renal
denervation space. High blood pressure is a global health issue,
and patients need more options to manage their blood pressure. The
approval of the Symplicity blood pressure procedure represents a
significant milestone for physicians and patients in the treatment
of hypertension."
The Medtronic Symplicity blood pressure procedure is an
innovative, minimally invasive procedure that delivers
radiofrequency energy to nerves near the kidneys that can become
overactive and contribute to high blood pressure. After sedation,
the doctor inserts a single thin tube (known as a catheter) into
the artery leading to the kidney. Once the tube is in place, the
doctor administers energy to the system to calm the excessive
activity of the nerves connected to the kidney. The tube is
removed, leaving no implant behind.
"The Symplicity blood pressure procedure is safe and effective,
providing significant 'always on' blood pressure reductions for
patients," said David Kandzari,
M.D., chief, Piedmont Heart Institute and Cardiovascular Service
and co-principal investigator of the SPYRAL clinical program. "This
landmark approval is the culmination of rigorous scientific study
and clinical trials, including long-term, sham-controlled studies
in the presence and absence of medication, and the largest
real-world study."
Patient preference and shared decision making have been
identified as critical components of developing a hypertension care
plan including the Symplicity blood pressure procedure. According
to results from a Medtronic-led patient preference study, when
presented with an interventional treatment with blood pressure
reduction and potential risks in line with those of the Symplicity
blood pressure procedure, approximately one third of patients were
likely to choose the interventional treatment.
"This approval paves the way for a transformation in
hypertension treatment, offering a solution that complements
medication and lifestyle changes," said Raymond Townsend, M.D., from the Hypertension
Section, Department of Internal Medicine / Renal, University of Pennsylvania School of Medicine and
co-principal investigator of the SPYRAL clinical program. "The
Symplicity blood pressure procedure is a promising treatment option
for clinicians and patients alike and offers opportunity to fulfill
a significant unmet need in hypertension care, especially for those
patients who are desperately seeking additional approaches to get
their blood pressure down."
The Medtronic SPYRAL HTN Global Clinical Program is the most
comprehensive clinical program studying RDN and is backed by
experience in more than 25,000 patients treated globally, studied
in the presence and absence of medication, and in patients with
high baseline cardiovascular risk. Although currently limited for
investigational use in Japan,
China and Canada, the Symplicity Spyral Renal
Denervation System is approved for commercial use in more than 70
countries around the world.
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 95,000+ 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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Ryan Weispfenning
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SOURCE Medtronic plc