Landmark SPYRAL HTN-OFF MED Pivotal Trial Shows Superiority for Renal Denervation in Patients with High Blood Pressure Compar...
29 März 2020 - 5:45PM
Landmark SPYRAL HTN-OFF MED Pivotal Trial Shows Superiority for
Renal Denervation in Patients with High Blood Pressure Compared to
Sham Procedure
Medtronic plc (NYSE:MDT), the global leader in medical
technology, today announced first-ever clinical data from the
SPYRAL HTN-OFF MED Pivotal Trial. The prospectively powered study
of patients with uncontrolled high blood pressure (BP) not taking
anti-hypertensive medications met its primary and secondary
effectiveness endpoints, with a >99.9% probability of
superiority for both versus those who received a sham control
procedure. Additionally, there were no major device or procedural
safety events through three months. The study was presented today
as part of the American College of Cardiology together with the
World Congress of Cardiology Scientific Sessions (ACC.20/WCC) and
published simultaneously in The Lancet.
The global, sham-controlled study evaluated 331
patients—166 of whom were randomized to renal denervation (RDN), a
minimally invasive procedure intended to regulate overactivity of
nerves that lead to and from the kidney. Results showed a
statistically significant 9.2 mm Hg reduction in patients’ office
systolic blood pressure (OSBP) and 4.7 mm Hg reduction in 24-hour
systolic ambulatory blood pressure (ABPM) at three months in those
treated with the Symplicity Spyral RDN system. Blood pressure
reductions were sustained consistently throughout the day and
nighttime periods, which may offer an important benefit as
cardiovascular risk is higher during the nighttime period.
Anti-hypertensive medications (if prescribed) were discontinued for
at least three weeks prior to randomization.
“These exciting results definitively demonstrate
that RDN lowers blood pressure, including over the 24-hour period,”
said Prof. Michael Böhm, M.D., Ph.D., chief of cardiology at the
University Hospital Homburg/Saar in Germany. “These new
findings complement the broader SPYRAL Program further reinforcing
RDN as a treatment option for patients with uncontrolled
hypertension.”
At three months, the study showed:
- RDN was superior to sham in all BP measures (24-hour ABPM
and Office BP, systolic and diastolic).
- RDN had significantly greater BP reductions vs. sham
control in both 24-hour systolic ABPM (4.0 mmHg, p<0.001), and
office systolic BP ( 6.6 mmHg, p<0.001).
“As many patients with uncontrolled hypertension
struggle to adhere to lifelong drug therapy for a variety of
reasons and may look to other options that complement traditional
treatments, we believe this advance could help clinicians work with
patients to better manage their high blood pressure,” said Dave
Moeller, vice president and general manager of the Coronary and
Renal Denervation business, which is part of the Cardiac and
Vascular Group at Medtronic. “Medtronic is committed to the field
of renal denervation and in addressing the unmet need in
hypertension management globally, and we look forward to seeing
more insights from our industry-leading SPYRAL HTN clinical program
as we realize the full potential of the therapy.”
Medtronic also recently received Breakthrough
Device Designation by the FDA for the Symplicity Spyral renal
denervation system. The FDA Breakthrough Device Program is intended
to help patients receive more timely access to certain
technologies, such as renal denervation, that have the potential to
provide more effective treatment or diagnosis for life-threatening
or irreversibly debilitating diseases or conditions.
Hypertension is the single largest contributor to
cardiovascular death; it dramatically increases risk of heart
attack, stroke, heart failure, and kidney failure. The annual
direct costs of hypertension are estimated at approximately $400
billion worldwide. It is estimated that almost 20% of patients with
uncontrolled hypertension are completely non-adherent to oral
medications, while nearly half are partially non-adherent,
highlighting the need for alternative treatment options.
The SPYRAL HTN-OFF MED Pivotal Trial is part of
the SPYRAL HTN Global Clinical Trial Program and accompanies the
SPYRAL HTN-ON MED Trial and the SPYRAL DYSTAL Study. Along with the
Global Symplicity Registry, conducted outside the United States,
Medtronic’s renal denervation program includes more than 4,000
patients, studied in the presence and absence of medication, and in
patients with high baseline cardiovascular risk. Approved for
commercial use in more than 60 countries around the world, the
Symplicity Spyral system is limited to investigational use in the
United States, Japan and Canada.
Analyst and Investor BriefingMedtronic will
host a webcast on Sunday, March 29, 2020, from 4:00 p.m. to 5:00
p.m. Central Daylight Time. The webcast will feature remarks on the
company and recent clinical data announcements from the Medtronic
Cardiac and Vascular Group management team. The live audio webcast
can be accessed by clicking on the Investor Events link
at http://investorrelations.medtronic.com on March 29.
Within 24 hours of the webcast, a replay will be available on the
same page. This event is not part of the official ACC.20/WCC
program.
About MedtronicMedtronic plc
(www.medtronic.com), headquartered in Dublin, Ireland, is among the
world's largest medical technology, services and solutions
companies - alleviating pain, restoring health and extending life
for millions of people around the world. Medtronic employs more
than 90,000 people worldwide, serving physicians, hospitals and
patients in more than 150 countries. The company is focused on
collaborating with stakeholders around the world to take healthcare
Further, Together.
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.
-end-
Joey LomickyPublic Relations+1-763-526-2494
Ryan WeispfenningInvestor Relations +1-763-505-4626
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