Medtronic adds to SPYRAL HTN Global Clinical
Program with late breaking clinical data for SPYRAL HTN-ON MED and
GSR-DEFINE
DUBLIN and PARIS, May 17, 2022
/CNW/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare
technology, today announced data showing the benefits of the
Symplicity Blood Pressure Procedure with the Symplicity Spyral™
Renal Denervation (RDN) system on achieving target blood pressure
level ranges. As part of the SPYRAL HTN Global Clinical Program,
three-year data from SPYRAL HTN-ON MED and GSR-DEFINE were
presented at EuroPCR 2022 as late-breaking clinical trials
on May 17, 2022.
Time in target range (TTR) plays an important role in the
management of many chronic diseases, such as diabetes and
hypertension, measuring how well a parameter (e.g., blood pressure)
is controlled in patients. Specifically, for hypertension,
increasing TTR has been shown to be an independent predictor of
reductions in cardiovascular risks, including stroke, heart attack,
and death.1 In a recent consensus statement by the
Society for Cardiovascular Angiography & Interventions and the
National Kidney Foundation, TTR is recognized as an effective
measure of blood pressure control. As part of the statement, TTR is
also noted as an important consideration to include as an endpoint
in clinical trials and registries.
"The data presented today at EuroPCR provide meaningful insights
into the benefits of RDN through a patient lens, looking at how
much time they spend within a target BP range," said Jason Weidman, senior vice president and
president of the Coronary & Renal Denervation business, which
is part of the Cardiovascular Portfolio at Medtronic. "This new
data reinforces RDN's effectiveness as a complementary solution for
achieving better blood pressure control and reducing cardiovascular
risk."
SPYRAL HTN-ON MED 3-Year Data
Results from the first
80 patients in the SPYRAL HTN-ON MED trial demonstrate improved BP
control with significantly higher TTR after radiofrequency RDN when
compared to sham through three years, regardless of
anti-hypertensive medications. TTR for patients treated with RDN
(33.7% TTR) was nearly double of sham patients (18.8% TTR) through
three years (p=0.023).
SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial
investigating the blood pressure lowering effect and safety of RDN
with the radiofrequency-based Medtronic Symplicity Spyral system in
hypertensive patients prescribed one to three anti-hypertensive
medications. The trial enrolled 80 typical uncontrolled
hypertensive patients, randomized to RDN (n=38) or sham control
(n=42).
The findings build upon the recent three-year safety and
efficiency data presented at ACC.22, which demonstrated safe and
sustained blood pressure reductions through three years.
"By focusing on TTR in patients with uncontrolled hypertension,
we can better understand how RDN can help control blood pressure
and sustain a healthy level," said Dr. David Kandzari, chief, Piedmont Heart Institute
and Cardiovascular Services and SPYRAL HTN-ON MED lead principal
investigator. "These three-year data showed us that RDN nearly
doubles the time patients spend in their target blood pressure
range, regardless of anti-hypertensive medications, reinforcing the
long-term benefit of the procedure."
GSR-DEFINE 3-Year Data
In the GSR-DEFINE study,
improved blood pressure control after radiofrequency RDN is
associated with lower risk of major adverse cardiovascular events
(MACE) through three years in real-world patients. RDN patients
spent 34.9% time in TTR through three years. There was also a 16%
decrease in MACE associated with every 10% increase in TTR at 6
months.
GSR-DEFINE is a prospective, all-comer observational study in
222 sites across 42 countries, including 3,000 patients from the
GSR study and enrolling up to an additional 2,000 patients.
"Results from this real-world patient setting closely mirror and
build upon data from the SPYRAL HTN-ON MED trial showing improved
blood pressure control with RDN. The findings from GSR-DEFINE
further underscore the long-term safety and effectiveness of the
Symplicity system in patients with uncontrolled hypertension, while
also lowering their risk of major cardiovascular events," said
Prof. Felix Mahfoud, M.D.,
cardiologist at Saarland University Hospital in Homburg,
Germany, and member of the SPYRAL
HTN executive committee.
About the Medtronic Symplicity Spyral™ Renal Denervation
System
The Medtronic RDN procedure uses a minimally invasive
procedure that delivers radiofrequency energy to specific nerves
near the kidneys that can become overactive and cause high blood
pressure. Approved for commercial use in more than 60 countries
around the world, the Symplicity Spyral renal denervation system is
limited to investigational use in the
United States, Japan, and
Canada.
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.
1 Fatani N, Dixon DL, Van Tassell BW, Fanikos J,
Buckley LF. Systolic Blood Pressure Time in Target Range and
Cardiovascular Outcomes in Patients With Hypertension. Journal
of the American College of Cardiology 2021;77:1290–1299.
https://doi.org/10.1016/j.jacc.2021.01.014
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SOURCE Medtronic plc