Medtronic, Inc. : Medtronic Gains First FDA Approval to Conduct Early Feasibility Medical Device Study

    Medtronic, Inc. : Medtronic Gains First FDA Approval to Conduct Early
                       Feasibility Medical Device Study

Medtronic, Inc.

 Shared Commitment to Innovation Enables Early Study of Novel Native Outflow
 Tract Transcatheter Pulmonary Valve in Patients with Pulmonary Valve Failure

MINNEAPOLIS - February 26, 2013 - Medtronic, Inc. (NYSE: MDT) today announced
that it has received U.S. Food and Drug Administration (FDA) approval to
conduct an early feasibility study using the Medtronic Native Outflow Tract
Transcatheter Pulmonary Valve (TPV). This approval represents the first-ever
FDA approval of an investigational device exemption (IDE) following the new
draft FDA guidance for early feasibility studies.

"The approval of this study is an excellent example of how the FDA and
manufacturers can work together to advance medical innovation by studying
initial device design and functionality, with the long-term goal of delivering
novel therapies to patients in need," said John Liddicoat, M.D., senior vice
president of Medtronic and president of the Medtronic Structural Heart
Business. "In this case, the early feasibility study will help us develop a
minimally invasive therapy for patients whose only current treatment option is
open-heart surgery."

The Native Outflow Tract TPV is a minimally invasive therapy for patients with
congenital heart disease who don't have a right ventricle-to-pulmonary artery
conduit, and need a pulmonary valve to maintain adequate blood flow from the
right ventricle and the pulmonary artery. Delivered in a minimally invasive
procedure using a catheter (small tube) funneled through the veins, the valve
is designed to restore pulmonary valve competency without invasive open-heart

The intent of the FDA's draft guidance, "Investigational Device Exemptions
(IDE) for Early Feasibility Medical Device Clinical Studies, including First
in Human (FIH) Studies," is to foster early-stage development of medical
devices within the U.S. It is a new approach to clinical studies conducted in
the early stages of development, and is designed to facilitate early clinical
experience with investigational medical devices to reach patients sooner and
create incentives to innovate in the United States.

This new approach is intended to allow studies to start earlier in the device
development process than previously allowed, while still providing appropriate
human subject protections. It also permits sponsors (manufacturers) and FDA
device reviewers more flexibility to make device modifications once the study

The Medtronic early feasibility study will evaluate the design, procedural
success and initial performance of the Native Outflow Tract TPV to enable
further development of the device prior to conducting an additional clinical

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. (, 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

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Kathleen Janasz
Public Relations

Jeff Warren
Investor Relations


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Source: Medtronic, Inc. via Thomson Reuters ONE
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