Company commits to advancing clinical data for
Symplicity™ with the SPYRAL Gemini clinical trial and expansion of
the GSR-DEFINE clinical trial
GALWAY, Ireland and WASHINGTON, Oct. 28, 2024 /PRNewswire/ --
Medtronic plc (NYSE: MDT), a global leader in healthcare
technology, today announced new, long-term data from its SPYRAL
HTN-ON MED clinical trial that showed subjects who underwent
radiofrequency renal denervation with the Symplicity™ Spyral renal
denervation (RDN) system had significantly greater reductions in
24-hr ambulatory systolic blood pressure (ABPM), and office-based
systolic blood pressure (OSBP) compared to sham patients at two
years. The data were presented as a part of the 2024 Transcatheter
Cardiovascular Therapeutics Conference (TCT).
"These findings are a key step toward informing the medical
community of the long-term effectiveness with radiofrequency renal
denervation as a treatment for uncontrolled hypertension," stated
Dr. David Kandzari, Chief of
Piedmont Heart Institute and Cardiovascular Services and lead
principal investigator of the SPYRAL HTN-ON MED trial.
"Importantly, at two years, we continue to see Symplicity is safe
and consistent with clinically meaningful and significant blood
pressure reductions. These data further substantiate sustained
blood pressure reductions consistently observed in across
the SPYRAL and Global Symplicity clinical programs."
The two-year data is consistent with other long-term data for
Symplicity RDN, demonstrating clinically meaningful, consistent and
sustained blood pressure reductions.1,2 At two years,
the data showed:
- Significant group differences in 24-hr ABPM and OSBP in favor
of RDN, despite significantly more medications detected in the sham
group
- 24 months ABPM: -12.1 mmHg in RDN group vs. -7.0 mmHg in
sham group (treatment difference: -5.7 mmHg; p=0.039)
- OSBP: -17.4 mmHg in the RDN group vs. -9.0 mmHg in the sham
group (treatment difference: -8.7 mmHg; p=0.0034)
- Long-term safety with no confirmed renal artery stenosis
greater than 70% in the Spyral group at two years
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 Symplicity Spyral RDN system in
hypertensive patients who have been prescribed up to three
anti-hypertensive medications. After the six-month primary endpoint
assessment, the study continued to assess 24-hr ABPM and OSBP from
baseline through yearly follow ups.
SPYRAL GEMINI Clinical Program
Medtronic
intends to investigate multi-organ (hepatic artery and
renal artery) denervation with the
Symplicity Spyral catheter. The
planned Global Pilot study of
rEnal and hepatic
coMbINed
denervatIon
(SPYRAL GEMINI pilot study) will
investigate the safety and efficacy of the multi-organ ablation
approach in uncontrolled hypertension patients who are both on and
off medications.
"Medtronic is uniquely positioned to explore the blood pressure
lowering potential of multi-organ denervation. This is supported by
both its intellectual property and the Symplicity Spyral catheter
design, which enables access and treatment of the Common Hepatic
Artery - a vascular target rich with sympathetic innervation - with
the same single catheter," said Jason
Weidman, senior vice president and president of the Coronary
and Renal Denervation business within the Cardiovascular Portfolio
at Medtronic. "The promising preclinical data highlight the
potential for interventional denervation in the liver to support
additional blood pressure lowering effects of the
procedure.3 This approach underscores our dedication to
innovation for both patients and physicians."
The utilization of Symplicity Spyral in the hepatic artery is
investigational and not approved for use.
GSR-DEFINE Expands to the United
States
Medtronic will also expand the GSR-DEFINE
clinical trial to sites in the United
States. The GSR-DEFINE trial is an extension of the Global
SYMPLICITY Registry, and is a prospective, all-comer observational
study in 251 sites across 55 countries, including 3,000 patients
from the GSR study and enrolling up to an additional 2,000 patients
globally.
"This year at TCT, we are not only reinforcing the consistent,
long-term effects of radiofrequency denervation, but we're further
demonstrating our commitment to evidence generation and
innovation," said Jason Fontana,
PhD, general manager Renal Denervation, and vice president of
Global Marketing for the Coronary and Renal Denervation
business. "As the leader in interventional hypertension treatments,
we are excited to extend the largest evidence platform available to
U.S. physicians and their patients."
Approved for commercial use in over 75 countries around the
world, the Symplicity Spyral renal denervation system is currently
limited to investigational use in Japan.
About Medtronic
Bold thinking. Bolder actions. We are
Medtronic. Medtronic plc, headquartered in Galway, 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 more than
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 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 Mahfoud F, Kandzari DE, Kario K, 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. The Lancet. 2022; 399:1401-1410.
2 GSR 2024 update: Mahfoud et al.EuroPCR. 2024
3 Tzafriri, A.R., et al Morphometric analysis of the
human common hepatic artery reveals a rich and accessible target
for sympathetic liver denervation. Sci Rep 12, 1413 (2022).
https://doi.org/10.1038/s41598-022-05475-6
Contacts:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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