Medtronic, Inc. : Symplicity(TM) Renal Denervation System One of First Devices Accepted to Participate in Concurrent Review for

Medtronic, Inc. : Symplicity(TM) Renal Denervation System One of First Devices
Accepted to Participate in Concurrent Review for Joint FDA Premarket Approval
                 and Medicare National Coverage Determination

Medtronic, Inc.

   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
participate 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
year.

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 vessels.

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.^[1]^,^[2] Research suggests that
nearly one third of treated hypertensive individuals are considered resistant
to treatment.^[3]

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 implant.

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 -

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[1] Egan, Brent M., et al. "Uncontrolled and Apparent Treatment Resistant
Hypertension in the United States, 1988-2008."Circulation 2011;124:1046-1058.

[2] Hypertension and cardiovascular disease.World Heart Federation. 2011.
http://www.world-heart-federation.org/ cardiovascular-health/cardiovascular-
disease-risk-factors/hypertension/. Accessed January 23, 2012.

[3] 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.

 

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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