DUBLIN - April 1, 2015 -
Medtronic plc (NYSE:MDT) today announced the initiation of the
SPYRAL HTN Global Clinical Trial Program, a unique, phased clinical
program studying renal denervation in uncontrolled hypertension.
This announcement follows investigational device exemption (IDE)
approval by the U.S. Food and Drug Administration (FDA). The
program will begin with two global studies designed to address the
confounding factors encountered in the SYMPLICITY HTN-3 clinical
trial, including medication, patient population and procedural
variability, to ensure the clinical potential of the therapy is
evaluated.
Physicians in both studies will perform renal
denervation with Medtronic's next-generation renal denervation
technology, composed of the highly flexible 6 Fr compatible,
multi-electrode Symplicity Spyral(TM) catheter and Symplicity
G3(TM) radiofrequency (RF) generator. The Symplicity Spyral
catheter and G3 generator are investigational in the United States
and Japan.
"Medtronic believes the underlying science behind
renal denervation is strong and that there is a clear unmet need
for people with uncontrolled hypertension. Therefore, we remain
committed to exploring the clinical potential of renal denervation
in this population," said Jason Weidman, vice president and general
manager, Medtronic Coronary and Renal Denervation, within
Medtronic's Coronary and Structural Heart business. "To get to this
point, we've performed extensive analyses and conducted additional
pre-clinical testing following the SYMPLICITY HTN-3 trial. We've
also consulted with the FDA and reimbursement bodies, and partnered
with renowned thought-leaders worldwide to develop this novel
clinical trial protocol."
The principal investigators for the initial two
global studies represent some of the most experienced renal
denervation specialists, including: Michael Böhm, M.D., Ph.D.,
chairman, Department of Internal Medicine, University of Saarland
in Homburg/Saar, Germany; David Kandzari, M.D., director and chief
scientific officer, Piedmont Heart Institute in Atlanta, Ga.;
Kazuomi Kario, M.D., chairman, Department of Cardiovascular
Medicine, Jichi Medical University School of Medicine in Tochigi,
Japan; and Raymond Townsend, M.D., director of the hypertension
program, University of Pennsylvania.
The SPYRAL HTN Global Clinical Trial Program
includes two global, prospective, randomized, sham-controlled
trials conducted simultaneously by experienced proceduralists to
investigate the impact of renal denervation both in the absence of
and in the presence of antihypertensive medications. The SPYRAL
HTN-OFF MED and SPYRAL HTN-ON MED studies will each include
approximately 100 patients with moderate- to high-risk
hypertension, as opposed to the severe, treatment resistant
population studied in the SYMPLCITY HTN-3 trial. These
studies will be conducted at approximately 20 centers in the U.S.
and other global geographies.
The SPYRAL HTN-OFF MED study is designed to
isolate the effect of renal denervation on blood pressure
reduction. Similar to the traditional design of antihypertensive
pharmaceutical clinical trials, this approach was recommended by
both the FDA and the global clinical community.
Separately, the SPYRAL HTN-ON MED study will
evaluate the effect of renal denervation on blood pressure in the
presence of antihypertensive medication. Unlike the SYMPLICITY
HTN-3 trial, which enrolled patients with very high blood pressure
that was not controlled despite an average of five antihypertensive
medications at maximum tolerated dosages, the SPYRAL HTN-ON MED
study requires patients who, despite use of drugs from three of the
most common classes of medications prescribed for hypertension, do
not achieve adequate blood pressure control. These drugs are not
required to be prescribed at maximum tolerated medication dosages,
a factor which may have contributed to variability in patient
adherence and the large number of medication changes during the
SYMPLICITY HTN-3 trial. Additionally, patient medication adherence
will be closely monitored and there will be a focus on ambulatory
blood pressure monitoring (ABPM) to ensure consistency between both
arms of the on- and off-medication studies.
"Studying patients both on and off medication in a
less severe and more homogenous population than we saw in the
SYMPLICITY HTN-3 trial is critical to gaining clarity on the true
effect of this therapy," said Dr. Townsend. "By specifying
medication classes and not requiring maximum tolerated doses, we
can expect medication variability to be reduced, which will allow
for a more controlled assessment of the impact of renal denervation
in the presence of medication."
Based on the outcomes of these two initial studies
of the SPYRAL HTN Global Clinical Trial Program, Medtronic will
evaluate next steps for a pivotal study to support a pre-market
application (PMA) submission to the FDA and Shonin submission in
Japan.
"With this clinical program, Medtronic continues
to make significant contributions to the field of renal
denervation," Prof. Böhm added. "Not only will these data add to
the scientific basis for renal denervation at large, but if we see
positive outcomes, it will help reinforce what many physicians have
experienced in their practice, and will provide even more
confidence to support continued use of the therapy in geographies
where the technology is currently available."
In collaboration with leading clinicians,
researchers and scientists, Medtronic offers the broadest range of
innovative medical technology for the interventional and surgical
treatment of cardiovascular diseases and cardiac arrhythmias. The
company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers
worldwide.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is the global leader in medical technology - alleviating
pain, restoring health, and extending life for millions of people
around the world.
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-
Contacts:
Wendy Dougherty
Public Relations
+1-763-381-1204
Jeff Warren
Investor Relations
+1-763-505-2696
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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