Medtronic Launches New GSR-DEFINE Study to Expand Real-World
Data to 5,000 Patients
DUBLIN, May 18, 2021 /CNW/ -- Medtronic
plc (NYSE:MDT), the global leader in medical technology, today
announced new clinical data from the Global SYMPLICITY
Registry (GSR) indicating that renal denervation (RDN) with the
Medtronic Symplicity™ Renal Denervation System was associated
with clinically significant and sustained blood pressure reductions
in a real-world hypertensive patient population through three
years. Results from the prospective, single-arm, global,
observational study are being presented as a Late-Breaking Clinical
Trial session at the 2021 EuroPCR Annual Meeting.
The study analyzed nearly 3,000 patients with uncontrolled
hypertension (HTN) and other comorbidities typical in HTN patients
(chronic kidney disease, diabetes). Patients were treated with the
Symplicity Renal Denervation System utilizing the single electrode
Symplicity Catheter or the Symplicity Spyral Multi-Electrode
Catheter, and their outcomes were analyzed up to three years post
procedure. RDN with the radiofrequency based Symplicity Renal
Denervation System is a minimally invasive procedure intended to
regulate overactivity of nerves that lead to and from the kidney,
which play an important role in blood pressure control.
The GSR study results demonstrated the Symplicity Renal
Denervation System led to significant and clinically
meaningful reductions in blood pressure that were sustained out to
three years post-procedure. Patients experienced a mean reduction
of 16.7 mmHg office systolic blood pressure (OSBP) at three years
compared to baseline.
Investigators also evaluated the benefit of RDN within various
patient subgroups using a clinical composite endpoint; a
retrospective analysis comprised of both OSBP, 24-hour ambulatory
blood pressure (ABPM) and medication burden. They found a
consistent benefit of RDN in patients with versus without diabetes,
chronic kidney disease, or patients who were 65 years and above.
The similar clinical composite endpoint was used in a recent
EuroIntervention publication that showed patients were
nearly three times more likely to benefit from RDN compared to
remaining on a regime of anti-hypertensive medications alone (Win
Ratio = 2.78, p<0.001).1
"As we continue to expand our clinical data around renal
denervation for uncontrolled hypertension management, we wanted to
broaden our understanding of the long-term benefits for our
patients who suffer from multiple chronic conditions and are
typically prescribed multiple medications," said Felix Mahfoud, M.D., cardiologist at Saarland
University Hospital in Homburg, Germany and principal investigator in the
study. "With this new analysis, we can now help patients
continue to see the real-world benefits of renal denervation."
EuroPCR: New Analysis on Estimated Risk Reduction from
Symplicity RDN System
In addition to the Late Breaking
Clinical Trial results at EuroPCR, investigators also reported a
new analysis estimating the reduction in clinical events in
patients treated with the Symplicity RDN system. The analysis used
the clinical events observed at three years in the Global
SYMPLICITY Registry and put these in perspective with a modeled
control. The results showed a 26% relative risk reduction in major
cardiovascular events (MACE) over three years for the full study
cohort treated with RDN, and a 34% reduction for patients suffering
from resistant hypertension over the same timeframe.
Medtronic Expands RDN Real-World Data Collection with the New
GSR-DEFINE Study
Building on the success of GSR and
continuing its commitment to providing real-world evidence for the
Symplicity Spyral Renal Denervation System, Medtronic also
announced today launch of the GSR-DEFINE Study. This new phase of
patient data collection aims to enroll an additional 2,000 patients
suffering from uncontrolled hypertension, who will be treated with
the Medtronic Symplicity Spyral Multi-Electrode Renal Denervation
Catheter. The study will collect data for a subgroup of patients
out to five years.
"Medtronic's commitment to creating a minimally invasive
solution to treat patients with uncontrolled high blood pressure is
evident through our growing body of clinical evidence as part of
our Symplicity Global Clinical Program," said Jason Weidman, senior vice president and
president of the Coronary & Renal Denervation business unit,
which is part of the Cardiovascular Portfolio at Medtronic. "The
data presented today at EuroPCR not only add to our understanding
of RDN's durability as a tool for hypertension treatment, but it
also continues to propel Medtronic as a leader in this space."
About the Medtronic Symplicity Spyral Clinical
Program
Along with the GSR and GSR-DEFINE studies, the
Medtronic Symplicity Global Clinical Program also includes the
SPYRAL HTN-OFF MED PIVOTAL and SPYRAL HTN-ON MED trials, both
prospectively powered, randomized, sham-controlled studies
evaluating patients with uncontrolled blood pressure in the absence
and presence of prescribed anti-hypertensive medications
respectively.2
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 U.S., Japan and Canada.
About Medtronic
Medtronic 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.
1 Kandzari et al, Prioritised endpoints for
device-based hypertension trials: the win ratio methodology,
EuroIntervention 2021; 16:e1496-e1502
2 Böhm M, et al. Lancet.
2020;395(10234):1444-1451
Contacts:
|
|
|
|
|
|
|
|
|
|
Krystin Hayward
Leong
|
|
|
|
Ryan
Weispfenning
|
Public
Relations
|
|
|
|
Investor
Relations
|
+1-508-261-6512
|
|
|
|
+1-763-505-4626
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/late-breaking-data-at-europcr-demonstrates-long-term-benefits-of-medtronic-radiofrequency-renal-denervation-in-real-world-hypertensive-patients-301293582.html
SOURCE Medtronic plc