Medtronic, Inc. : Trial of Medtronic Symplicity(TM) Renal Denervation System Shows Significant Blood Pressure Reduction, With No Evidence of Renal Impairment, at Six Months Post Treatment
04/27/2012| 12:55pm US/Eastern
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MINNEAPOLIS & LONDON, Apr 27, 2012 (BUSINESS WIRE)
--Medtronic, Inc., (NYSE: MDT), announced today six month
pooled outcomes from randomized and crossover patients in the
Symplicity HTN-2 clinical trial following renal denervation
with the Symplicity(TM) renal denervation system showing
significant, sustained blood pressure reduction in patients
with treatment-resistant hypertension. These data presented
today at the European Society of Hypertension annual meeting
showed patients (n=84) who received renal denervation
treatment with Symplicity experienced a mean blood pressure
reduction of -28/-10 mm Hg (p<0.001) at six months
following treatment compared with baseline. No evidence of
renal impairment was observed and renal function measures
remained unchanged.
This pooled analysis included change in blood pressure at six
months for all patients randomized to receive renal
denervation with Symplicity at baseline (n=49), as well as
patients in the control group (n=35) who met entry criteria
and crossed over to the treatment group following assessment
of the initial six month primary endpoint.
"The Symplicity clinical program is the longest and
largest clinical program of its kind evaluating renal
denervation in resistant hypertension," said Markus
Schlaich, M.D., associate professor,head, Hypertension &
Kidney Disease,Baker IDI Heart and Diabetes Institute in
Melbourne, Australia. "This largest pooled analysis of
controlled trial data at six months adds to the growing body
of clinical evidence about the safety, effectiveness and
sustainability of blood pressure reductions achieved with
renal denervation."
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. These nerves 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(TM) system's catheter and proprietary
generator and algorithms were carefully and specifically
developed through years of clinical experience to enhance the
safety and effectiveness of the renal denervation procedure.
The Symplicity renal denervation systemhas been successfully
used for nearly five years to treat more than 4,000 patients
with treatment-resistant hypertension worldwide.
"New treatment guidance issued by the European Society
of Hypertension on the use of renal denervation to treat
resistant hypertension supports the use of technology that
has demonstrated enduring safety and effectiveness safety in
clinical studies," said Sean Salmon, Senior Vice
President and President, Coronary & Renal Denervation,
Medtronic. "We believe our Symplicity technology
specifically designed for this procedure, coupled with
encouraging results from the Symplicity clinical trials with
three years of follow-up fall within these renal denervation
treatment guidelines."
Six-Month Pooled Outcome Data from the Symplicity HTN-2
Study
The Symplicity HTN-2 triali is an international,
multi-center, prospective, randomized, controlled study of
the safety and effectiveness of renal denervation in patients
with treatment-resistant hypertension. One hundred-six (106)
patients were enrolled from 24 investigational sites. At
baseline, the randomized treatment and control patients had
similar high blood pressures: 178/97 mm Hg and 178/98 mm Hg,
respectively, despite both receiving an average daily regimen
of five antihypertensive medications. Patients in the control
arm of the study were offered renal denervation following
assessment of the trial's primary endpoint at six months
following randomization. Pre-randomization, all patients in
the study had an office-based systolic blood pressure
greater-than or equal to 160 mm Hg despite adherence to at
least three antihypertensive medications given at optimal
dosage. Mean change in systolic and diastolic blood pressure
was -28/-10 mg Hg (n=84) from baseline (p<0.001) to six
months post-treatment. Renal function measures were unchanged
(eGFR: 82.1±20.2 vs. 80.5±18.9mL/min/1.73m2; p=NS). There was
one right artery dissection in a crossover patient, which
occurred while injecting contrast during angiography. No
other serious procedure-related adverse events occurred.
ABOUT TREATMENT-RESISTANT HYPERTENSION
Treatment-resistant hypertension, defined as persistently
high blood pressure despite three or more anti-hypertensive
medications of different types including a diuretic, puts
approximately 120 million people worldwide at risk of
premature death from kidney disease and cardiovascular events
such as stroke, heart attack and heart failure. Research
suggests that nearly one third of treated hypertensive
individuals are considered resistant to treatment.ii
Additionally, these patients have a three-fold increase in
risk of cardiovascular events compared to individuals with
controlled high blood pressure.iii
ABOUT THE SYMPLICITY(TM)RENAL DENERVATION SYSTEM
The Symplicity(TM) renal denervation systemwas launched
commercially in April 2010 and is currently available in
parts of Europe, Asia, Africa, Australia and the Americas.
The Symplicity renal denervation system is not approved by
the U.S. Food and Drug Administration (FDA) for commercial
distribution in the United States.
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 the renal artery. 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, or
pattern, 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 protocol for
SYMPLICITY HTN-3, the company's U.S. clinical trial of
the Symplicity renal denervation system for treatment
resistant hypertension in August 2011. SYMPLICITY HTN-3 is a
randomized controlled trial designed to evaluate the safety
and effectiveness of renal denervation with the Symplicity
renal denervation system in patients with treatment-resistant
hypertension. The study will include approximately 530
treatment-resistant hypertension patients across up to 90
U.S. medical centers. More information about HTN-3 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.
i Symplicity HTN-2 Investigators. "Renal sympathetic
denervation in patients with treatment-resistant hypertension
(The Symplicity HTN-2 Trial): a randomized, controlled
trial." The Lancet (2010) 376: 1093-1909.
ii Egan, Brent M., et al. "Uncontrolled and Apparent
Treatment Resistant Hypertension in the United States,
1988-2008." Circulation 124. 9 (2011): 1046-1058.
iii Doumas, Michael, et al. "Benefits from Treatment and
Control of Patients with Resistant Hypertension."
International Journal of Hypertension 2011 (2011) Article ID
318549, 8 pages, 2011. doi:10.4061/2011/318549.
Symplicity is a trademark of Medtronic Inc. and is registered
in one or more countries of the world.
SOURCE: Medtronic, Inc.
Medtronic, Inc.
Wendy Dougherty, 763-381-1204
Public Relations
or
Jeff Warren, 763-505-2696
Investor Relations
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