2013-03-07 16:03:08 -
IDE Submission for Symplicity HTN-4 Expands the Indicated Patient Population and
Builds upon Medtronic's Rigorous Global Clinical Trial Program for Hypertension
Treatment
MINNEAPOLIS - March 7, 2013 - Medtronic, Inc. (NYSE: MDT), announced today that
the company has submitted an Investigational Device Exemption (IDE) to the U.S.
Food and Drug Administration (FDA) to study the Symplicity(TM) renal denervation
system for the treatment of uncontrolled hypertension in patients with systolic
blood pressure between 140-160 mm Hg despite treatment with three or more anti-
hypertensive medications of different classes. The Symplicity renal denervation
system currently is only available for investigational use in the United States.
Symplicity HTN-4 is the next step in Medtronic's global renal denervation
clinical program designed to carefully and progressively build the clinical
evidence platform for the treatment of hypertension. This is being accomplished
through a series of trials, which include more than 250 patients already
enrolled in the Symplicity HTN-1 and Symplicity HTN-2 studies, 530 patients
being enrolled in the Symplicity HTN-3 study, and 5,000 patients being enrolled
in the Global SYMPLICITY Registry. The robust SYMPLICITY global dataset with
planned follow-up to 5 years in most studies will be utilized to evaluate not
only blood pressure reduction, but also long-term cardiovascular outcomes from
hypertension such as stroke, myocardial infarction, heart failure and
cardiovascular death. Medtronic's rigorous clinical evaluation program of the
Symplicity renal denervation system includes more than 8,000 patients worldwide,
including studies in the U.S., China, and Japan, with over 1,200 of these
patients participating in randomized clinical trials.
The Symplicity HTN-4 trial will be the company's second randomized clinical
trial in the U.S., with a patient population in line with the Joint National
Committee on the Prevention, Detection, Evaluation and Treatment of High Blood
Pressure (JNC-7), the American Heart Association and the European Society of
Hypertension definition of resistant hypertension. Symplicity HTN-4 builds upon
the Symplicity HTN-3 study, Medtronic's pivotal U.S. clinical trial of the
Symplicity renal denervation system for the treatment-resistant hypertension
with systolic blood pressure greater than 160 mm Hg. Symplicity HTN-3 is the
only clinical trial to date to receive an IDE approval to study renal
denervation in the U.S. Medtronic aims to begin enrolling patients in the
Symplicity HTN-4 trial in the second half of 2013, pending regulatory approval.
The principal investigators of Symplicity HTN-4 are David Kandzari, M.D.,
Director and Chief Scientific Officer, Interventional Cardiology and
Interventional Cardiology Research, Piedmont Heart Institute, Atlanta, GA, and
Michael Weber, M.D., Professor of Medicine, Division of Cardiovascular Medicine,
at the SUNY Downstate College of Medicine in Brooklyn, New York.
"Symplicity HTN-4 demonstrates Medtronic's commitment to providing randomized
safety and efficacy data for renal denervation in a wide variety of patients, as
well as help increase our understanding of the potential benefit of renal
denervation on patients with a less severe form of treatment-resistant
hypertension," said Sean Salmon, Senior Vice President and President, Coronary &
Renal Denervation, Medtronic. "We intend to continue to add to the substantial
body of evidence Medtronic has generated to support the use of renal denervation
in broader patient populations worldwide in conditions associated with
hyperactive sympathetic nervous system drive, including uncontrolled and
treatment-resistant hypertension, and heart failure."
Hypertension is a major and growing global public health concern. It affects an
estimated 30-40 percent of the adult population(1-3) and contributes directly to
strokes, heart attacks, heart failure and cardiovascular mortality.(4)(, )(5)
Numerous studies have demonstrated the continuous and consistent benefit in
terms of risk reduction with controlling blood pressure.(4-6) Despite the
availability of numerous safe pharmacological therapies, the percentage of
hypertensive patients achieving blood pressure control to guideline target blood
pressure values remains low.
In the United States, the control rate for hypertensive patients taking
medications is approximately 60 percent,(7) leaving many uncontrolled
hypertension patients at an increased cardiovascular risk. Many patients with
uncontrolled hypertension meet the criteria for treatment resistant hypertension
in that their systolic blood pressure is >= 140 mm Hg despite being on three or
more anti-hypertensive medications. The risk inherent with persistently high
blood pressure in these patients warrants special therapeutic considerations.(8)
Renal denervation therapy is a minimally invasive, catheter-based procedure that
modulates the output of nerves that lie within the renal artery wall and lead
into and out of the kidneys. The nerves passing to the kidneys are part of the
sympathetic nervous system, which affects the major organs that are responsible
for regulating blood pressure: the brain, the heart, the kidneys and the blood
vessels.
The Symplicity system's catheter and proprietary generator and algorithms were
carefully and specifically developed through years of clinical experience to
accomplish the renal denervation procedure. The Symplicity renal denervation
systemwas launched commercially in April 2010 and is currently available in
parts of Europe, Asia, Africa, Australia, Canada and Latin America and has been
used to treat thousands of patients with treatment-resistant hypertension
worldwide.
The Symplicity renal denervation system consists of a flexible catheter and
proprietary generator. In an endovascular procedure, similar to an angioplasty,
the physician inserts the small, flexible Symplicity((TM)) catheter into the
femoral artery in the upper thigh and threads it into both renal arteries in
turn. Once the catheter tip is in place within the renal artery, the
Symplicity((TM)) generator is activated to deliver a controlled, low-power
radio-frequency (RF) energy routine according to a proprietary algorithm aiming
to deactivate the surrounding renal nerves. This, in turn, reduces hyper-
activation of the sympathetic nervous system, which is an established
contributor to chronic hypertension. The procedure does not involve a permanent
implant.
The FDA granted Medtronic approval for the Symplicity HTN-3 study in August
2011. More information about Symplicity HTN-3, which is currently enrolling
patients, can be found at www.symplifybptrial.com.
In collaboration with leading clinicians, researchers and scientists worldwide,
Medtronic offers the broadest range of innovative medical technology for the
interventional and surgical treatment of cardiovascular disease and cardiac
arrhythmias.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, 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 -
Symplicity is a trademark of Medtronic Inc. and is registered in one or more
countries of the world.
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Contacts:
Wendy Dougherty
Public Relations
+1-763-381-1204
Jeff Warren
Investor Relations
+1-763-505-2696
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Source: Medtronic, Inc. via Thomson Reuters ONE
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