2013-03-06 18:16:07 -
FDA-CMS Parallel Review Program Designed to Enable Efficient and Earlier Patient
Access to Innovative Medical Advancements
MINNEAPOLIS - March 6, 2013 - Medtronic, Inc. (NYSE: MDT) today announced the
U.S. Food and Drug Administration (FDA)and the Centers for Medicare & Medicaid
Services (CMS) have accepted the inclusion of the Symplicity(TM) renal
denervation system for treatment-resistant hypertension in their parallel review
program, which will allow CMS to begin consideration for national coverage
determination while the FDA completes its review of safety and efficacy. The
Symplicity renal denervation system currently is only available for
investigational use in the United States.
The Symplicity renal denervation system is one of the first medical devices to
in the pilot program for concurrent review designed to facilitate
the development of innovative new products and increase the efficiency of the
review processes for both agencies. The two federal agencies accepted the
Symplicity renal denervation system into the parallel review pilot program
through a selection process that is limited to a few innovative devices per
The parallel review will be based primarily on results from Symplicity HTN-3,
Medtronic's U.S. clinical trial of the Symplicity renal denervation system for
treatment-resistant hypertension. In August 2011, the FDA approved Symplicity
HTN-3, allowing Medtronic to become the first company to conduct a randomized,
controlled trial of renal denervation in the U.S. Enrollment in this study is
ongoing expected to be complete by the summer of 2013.
"We are pleased that FDA and CMS have accepted the Symplicity renal denervation
system for parallel review. This joint review represents a significant step
forward in accelerating patient access to renal denervation in the U.S.," said
Sean Salmon, Senior Vice President and President, Coronary and Renal
Denervation, Medtronic. "We look forward to working with both agencies to ensure
an efficient and timely review so that we may offer a new treatment option for
the millions of people with treatment-resistant hypertension in the U.S."
Symplicity HTN-3 is a single-blind, randomized, controlled trial designed to
evaluate the safety and effectiveness of renal denervation with the Symplicity
renal denervation system in patients with drug-resistant hypertension. The study
will randomize 530 patients in up to 90 U.S. medical centers; patients in the
clinical trial will be randomized to receive either renal denervation and
treatment with anti-hypertensive medications or treatment with anti-hypertensive
medications alone. The primary endpoints of the study are the change in blood
pressure from baseline to six months following randomization and incidence of
major adverse events one month following randomization. More information about
Symplicity HTN-3 can be found at www.symplifybptrial.com.
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
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.
About the Symplicity(TM)Renal Denervation System
The Symplicity renal denervation 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 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
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
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
- end -
 Egan, Brent M., et al. "Uncontrolled and Apparent Treatment Resistant
Hypertension in the United States, 1988-2008."Circulation 2011;124:1046-1058.
 Hypertension and cardiovascular disease.World Heart Federation. 2011.
disease-risk-factors/hypertension/. Accessed January 23, 2012.
 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.
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Source: Medtronic, Inc. via Thomson Reuters ONE