DUBLIN and CHICAGO, Nov. 7, 2022
/CNW/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare
technology, today announced the six-month results from the full
cohort of the SPYRAL HTN-ON MED clinical trial. The data were
presented today as Late-Breaking Clinical Science at the American
Heart Association (AHA) Scientific Sessions 2022. With this
news, Medtronic has submitted the final module of the Symplicity
Spyral™ Premarket Approval (PMA) package to the U.S. Food and Drug
Administration (FDA) for review and approval.
Subjects who were prescribed antihypertensive medications and
were treated with the Medtronic Symplicity Spyral Renal Denervation
(RDN) System had a statistically significant and clinically
meaningful reduction in office-based systolic blood pressure
(OSBP), a key secondary endpoint, compared to subjects in the sham
control group. However, in the primary endpoint, RDN did not
demonstrate a statistically significant reduction in 24-hour
ambulatory systolic blood pressure (ABPM) due to increased
medications in the sham control group and the potential impacts of
the Covid-19 pandemic on the clinical trial environment. The study
also included Win Ratio, a pre-specified secondary endpoint that
combines reduction in blood pressure with reduction in medication
burden, which enables assessment of the overall beneficial effect
of RDN. The Win Ratio demonstrated significance in favor of RDN
versus a sham procedure. Finally, the study met its primary safety
endpoint, with a low incidence of procedure-related and clinical
adverse events.
"The ON MED study demonstrated significant reductions in
office-based blood pressure, the most commonly used measure in
clinical practice. Additionally, we saw reductions in absolute
blood pressure that were consistent with earlier RDN
studies," said David Kandzari, M.D., chief, Piedmont
Heart Institute and Cardiovascular Services and SPYRAL HTN-ON MED
lead principal investigator. "Surprisingly, 24-hour
ABPM declined with RDN but did not differ from the sham
group, and the primary endpoint was not met. More than 80% of
patients in the ON MED expansion group experienced follow up during
the Covid-19 pandemic. Compared with patients enrolled before the
pandemic, significant differences in baseline 24-hour
ABPM were observed that may reflect changes in patient behavior and
lifestyle during the pandemic.1,2,3 Additionally,
patients treated with the sham procedure increased the amount of
medication they were taking compared to those treated with
RDN. These factors likely contributed to the smaller than
expected differences in ABPM."
SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial
investigating the blood pressure lowering effect and safety of RDN
with the radiofrequency (RF)-based Symplicity Spyral RDN system in
hypertensive patients who have been prescribed up to three
anti-hypertensive medications, including diuretics, calcium channel
blockers, ACE/ARB inhibitors or beta blockers. A total of 337
patients with uncontrolled hypertension were enrolled at 42
sites across the United States,
Europe, Japan, Australia, and Canada, and were randomized 2:1 to RDN (n=205)
versus sham control (n=132). Results were as follows:
- The primary Bayesian efficacy endpoint of 24-hr systolic ABPM
reduction was not met, with a 51% probability of superiority for
the RDN group versus those who received a sham control procedure.
However, nighttime systolic ABPM reduction was statistically
significant.
-
- 6.5 mmHg 24-hr systolic ABPM reduction in the RDN group versus
4.5 mmHg in the control group (treatment difference of -1.9 mmHg,
p=0.119)
- 6.7 mmHg nighttime systolic ABPM reduction in the RDN group
versus 3.0 mmHg in the control group (treatment difference of -3.7
mmHg, p=0.01)
- The study met the prespecified secondary endpoint, which was
the change in OSBP from baseline to six-month follow-up between the
RDN group (n=199) and the sham control group (n=126).
-
- Statistically significant 9.9 mmHg OSBP reductions in the RDN
group versus a 4.9 mmHg reduction in the sham control group
(treatment difference of -4.9 mmHg, p=0.001)
- The study met the primary safety endpoint, evaluating major
adverse events at one-month post-procedure, and renal artery
stenosis at six-months, pooled across the SPYRAL HTN-ON and OFF MED
studies (p<0.001)
-
- RDN demonstrated a low incidence of procedure-related and
clinical adverse events at six-months in the SPYRAL HTN-ON MED
study specifically.
- The Win Ratio demonstrated significance in favor of RDN versus
a sham procedure (p=0.005).
- Overall burden of medications was higher in the sham control
group at six-months (p=0.04).
"Renal denervation lowers blood pressure and requires less
medication for patients with hypertension," said Laura Mauri, M.D., chief scientific, medical,
and regulatory officer at Medtronic. "It is also a safe procedure.
In this study specifically, RDN met both the safety endpoint for
this trial, as well as the overall safety endpoint across the
SPYRAL HTN ON and OFF MED studies."
The SPYRAL HTN-ON MED Trial4 is a part of the
Medtronic SPYRAL HTN Global Clinical Program – the most
comprehensive clinical program studying RDN - including the SPYRAL
HTN-OFF MED Pivotal Trial5 and the currently-enrolling
SPYRAL AFFIRM Study. Along with the real-world data from the
Global SYMPLICITY Registry (GSR)6, the Medtronic
RDN program is backed by experience in more than 20,000 patients
treated globally, studied in the presence and absence of
medication, and in patients with high baseline cardiovascular
risk.
"In addition to the consistent absolute blood pressure drops
that we have demonstrated across trials, long-term data from key
Medtronic studies— which were highlighted in two important
publications this year in The Lancet7,8— have
also demonstrated the durability and 'always on' effect of RDN,"
said Jason Weidman, senior vice
president and president of the Coronary and Renal Denervation
business, which is part of the Cardiovascular Portfolio at
Medtronic. "The ON MED results presented today serve as an
additional piece of our extensive compendium of safety and efficacy
evidence on this procedure. With these results in hand, we
submitted our PMA package to the FDA, which includes the totality
of available evidence from the SPYRAL HTN clinical program. We are
excited about the potential to bring this important procedure to
millions of U.S. patients in need."
Approved for commercial use in more than 60 countries around the
world, the Symplicity Spyral RDN system is limited to
investigational use in the United
States, Japan, and
Canada.
Investor and Analyst Briefing
Medtronic will host a webcast of its Renal Denervation Investors
and Analyst Briefing on Monday, November 7,
2022 from 5:00 p.m. to 6:00 p.m.
CST. The webcast will feature remarks from Medtronic
Coronary and Renal Denervation management, including comments on
Medtronic's clinical data for the six-month primary results from
the SPYRAL HTN-ON MED Randomized Trial. The live audio webcast can
be accessed by clicking on the Investor Events link at
investorrelations.medtronic.com on November
7. Within 24 hours of the webcast, a replay will be
available on the same webpage. This event is not part of the
official AHA 2022 program.
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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Krystin Hayward
Leong
|
Ryan
Weispfenning
|
Public
Relations
|
Investor
Relations
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+1-508-261-6512
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+1-763-505-4626
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____________________________________
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1 Kreutz et
al. Journal of Hypertension 2021
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2 Azzouzzi
et al. Int. J. Environ. Res. Public
Health 2022
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3 Laffin et
al. Circulation 2021
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4 Kandzari
D, Bӧhm M, Mahfoud F, et al. Effect of renal denervation on blood
pressure in the presence of antihypertensive drugs: 6-month
efficacy and safety results from the SPYRAL HTN-ON MED
proof-of-concept randomised trial. Lancet 2018; 391:
2346-55.
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5 Bӧhm M,
Kario K, Kandzari D et al. Efficacy of catheter-based renal
denervation in the absence of antihypertensive medications (SPYRAL
HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled
trial. Lancet 2020; 395:1444–51.
|
6 Mahfoud F,
Mancia G, Schmieder R, et al. Renal denervation in high-risk
patients with hypertension. J Am Coll Cardiol 2020; 75:
2879-88.
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7 Mahfoud,
F, Kandzari, D, Weber, M et al. Long-term efficacy and safety of
renal denervation in the presence of antihypertensive drugs (SPYRAL
HTN-ON MED): a randomised, sham-controlled trial.
Lancet. 2022; 399: 1401-1410.
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8 Bhatt DL,
Vaduganathan M, Kandzari DE, Long-term outcomes after
catheter-based renal artery denervation for resistant hypertension:
final follow-up of the randomised SYMPLICITY HTN-3 Trial.
Lancet. 2022; (published online Sept
18.).
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SOURCE Medtronic plc