Medtronic, Inc. : Medtronic Submits IDE to FDA for U.S. Randomized Clinical Trial for Uncontrolled Hypertension Patients with

 Medtronic, Inc. : Medtronic Submits IDE to FDA for U.S. Randomized Clinical
  Trial for Uncontrolled Hypertension Patients with Systolic Blood Pressure
                            Between 140-160 mm Hg

Medtronic, Inc.

 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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