MINNEAPOLIS–(BUSINESS WIRE)–Medtronic Inc. (NYSE: MDT) announced today the start of SYMPLICITY
HTN-3, the companys U.S. clinical trial of the Symplicity® Renal Denervation
System™ for treatment-resistant hypertension. The first patient in this
landmark study was enrolled at the Prairie Heart Institute at St. Johns Hospital
in Springfield, Ill.
Treatment resistant hypertension, defined as persistently
high blood pressure despite three or more antihypertensive medications of different
types, 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.
Renal denervation is a minimally invasive, catheter-based
procedure that modulates the output of nerves that line the walls of the
arteries leading to the kidneys. The targeted nerves are part of the
sympathetic nervous system, which has been found to play a central role in
blood pressure regulation.
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 enroll approximately 530 treatment-resistant hypertension
patients across 60 U.S.
medical centers. All patients and hypertension follow-up assessors will be
blinded to the randomization assignments to remove any potential for bias. The
primary endpoints of the study are the change in blood pressure from baseline
to six months and incidence of major adverse events up to six months following
randomization.
More information about SYMPLICITY HTN-3 and renal
denervation is available online at www.SymplifyBPtrial.com.
“Renal denervation has the potential to extend the lives of
millions of people who suffer from treatment-resistant hypertension,” said
Krishna Rocha-Singh, M.D., medical director of the Prairie Vascular Institute
and the Prairie Education and Research Cooperative. “Based on the results of
prior clinical studies and contemporary clinical practice, this interventional
technique could be one of the most significant advances in our approach to
addressing this insidious disease to be developed in decades.”
The Prairie Heart Institute has significant prior experience
with renal denervation from having been the top U.S. site for SYMPLICITY HTN-1, the
original feasibility study of the Symplicity Renal Denervation System for
treatment-resistant hypertension. The sites principal investigators (PIs) are
Richard Katholi, M.D., and Nilesh Goswami, M.D.
The national PIs of SYMPLICITY HTN-3 are George Bakris,
M.D., and Deepak L. Bhatt, M.D., M.P.H. Dr. Bakris is professor of medicine and
director of the Hypertension
Center at the University
of Chicago Medical Center and president of the American Society of
Hypertension. Dr. Bhatt is associate professor of medicine at Harvard Medical
School, chief of
cardiology for the VA Boston Healthcare System and director of the Integrated
Interventional Cardiovascular Program at Brigham and Womens Hospital and the
VA Boston Healthcare System.
The Symplicity Renal Denervation System consists of a
proprietary generator and flexible catheter. The Symplicity catheter is
introduced through a separate catheter placed through the skin into the femoral
artery, located in the upper thigh, and is then threaded up into the renal
artery leading to each kidney. It is connected to the Symplicity generator,
which produces low-power radio-frequency (RF) energy.
Once in place within the renal artery, the tip of the
Symplicity catheter is placed against the arterial wall in several places where
it delivers RF energy to the surrounding sympathetic nerves according to a
proprietary, computer-controlled algorithm. The treatment does not involve a
permanent implant and is performed under conscious sedation.
The Symplicity Renal Denervation System has been
successfully used since 2007 to treat more than 2,000 patients worldwide. It
has been commercially available in Europe and Australia since April 2010. The
Symplicity System is not approved by the U.S. Food and Drug Administration
(FDA) for commercial distribution in the United States. The FDA granted
Medtronic approval for the SYMPLICITY HTN-3 protocol in August.
Clinical research to date shows that renal denervation with
the Symplicity Renal Denervation System may provide a significant and sustained
reduction in blood pressure levels for many patients with treatment-resistant
hypertension. Published in The Lancet (Dec. 4, 2010), results from SYMPLICITY
HTN-2 –– a randomized, controlled trial of 106 patients in Europe and Australia
–– showed that patients with treatment-resistant hypertension randomized to
renal denervation achieved a mean blood pressure reduction of 32/12 mmHg
(millimeters of mercury) at six months, whereas the patients in the control
group randomized to anti-hypertensive medications alone had blood pressures
that did not vary from baseline (1/0 mmHg). The overall occurrence of adverse
events did not differ between groups.
Hypertension is the leading attributable cause of death
worldwide. It is a significant, costly and escalating global healthcare problem
affecting approximately 1.2 billion people, and is associated with an increased
risk of heart attack, stroke, heart failure, kidney disease and death.1 Among
adults aged 40–70 years old, each increment of 20 mmHg in systolic blood
pressure (the top number) or 10 mmHg in diastolic blood pressure (the bottom
number) doubles the risk of cardiovascular disease.2 Hypertension is estimated
to have a direct cost to the global healthcare system of more than $500 billion
annually.
Although pharmaceutical therapy plays a primary role in
hypertension management, drugs alone are not effective for all patients. As a
result, despite lifestyle changes and the availability of modern
antihypertensive agents, approximately 50 percent of patients with hypertension
remain uncontrolled and approximately 15–20 percent of those are treatment
resistant.3
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 Medtronics periodic reports on file
with the Securities and Exchange Commission. Actual results may differ
materially from anticipated results.
i Lawes, CM., et al. “Global burden of
blood-pressure-related disease.” 2001 The Lancet 371. 9623 (2008): 1513-1518.
ii Lewington S, Clarke R, Qizilbash N, et al. “Age-specific relevance of usual
blood pressure to vascular mortality: A meta-analysis of individual data for
one million adults in 61 prospective studies”. The Lancet. 2002;360:1903-13.
iii Circulation.<http://www.ncbi.nlm.nih.gov/pubmed/20019324> 2010 Feb
23;121(7):e46-e215. Epub 2009 Dec 17. Heart disease and stroke statistics 2010
update: a report from the American Heart Association.
