2013-01-23 16:02:55 -

Milestone in IN.PACT SFA II Brings FDA Submission for
Promising Interventional Treatment of Peripheral Artery Disease One Step Closer
                                    in U.S.

MINNEAPOLIS -- Jan. 23, 2013 -- Medtronic, Inc. (NYSE: MDT), today announced
completion of enrollment in IN.PACT SFA II, the U.S. arm of its clinical study
for the IN.PACT Admiral drug-eluting balloon as a treatment for peripheral
artery disease in the superficial femoral and proximal popliteal arteries (SFA
and PPA).

IN.PACT SFA II is a prospective, multicenter, randomized controlled trial that
enrolled 181 patients at more than 40 U.S. sites and randomized them   2:1 to
treatment with either the IN.PACT Admiral drug-eluting balloon (study arm) or a
traditional, non-coated angioplasty balloon (control arm). Its primary efficacy
endpoint is primary patency, a measure of blood flow through the treated
arterial segment, at 12 months.

The principal investigators of IN.PACT SFA II are interventional cardiologist
Dr. John Laird, professor of medicine at the University of California Davis and
medical director of the UC Davis Vascular Center, and vascular surgeon Dr. Peter
Schneider, chief of the vascular therapy division at Kaiser Foundation Hospital
and Hawaii Permanente Medical Group in Honolulu.
Results of IN.PACT SFA II will be combined with those from IN.PACT SFA I, which
previously completed enrollment of 150 patients in Europe, to support a
premarket approval (PMA) application to the U.S. Food and Drug Administration
(FDA).

"The European experience with IN.PACT drug-eluting balloons shows a promising
interventional treatment for peripheral artery disease in the lower
extremities," said Dr. Prakash Krishnan, assistant professor of medicine and
director of endovascular intervention at Mount Sinai Heart in New York, and the
highest enroller of patients in IN.PACT SFA II. "We look forward to sharing the
U.S. experience of this innovative medical technology as the results of IN.PACT
SFA II become available."

PACIFIER Trial Results

Meanwhile, results of European studies involving IN.PACT drug-eluting balloons
continue to be reported. For example, findings from the PACIFIER trial appeared
in the December 2012 issue of Circulation: Cardiovascular Interventions, showing
a clinically-driven target lesion revascularization rate at 12 months of 7.1
percent for the IN.PACT Pacific drug-eluting balloon versus 27.9 percent for the
non-coated balloon control arm (p=0.02).

The prospective, multicenter, corelab-adjudicated, randomized controlled
PACIFIER trial enrolled 85 patients with femoropopliteal lesions. Conducted in
three German institutions, it included 91 randomized cases -- 44 treated with a
drug-eluting balloon (study arm); 47 treated with a non-coated balloon (control
arm).

The study met its primary endpoint by showing a statistically significant
difference in reduction of late lumen loss at six months for the cases that used
a drug-eluting balloon as compared to those that used a non-coated balloon (-
0.01mm vs. 0.65mm, p=0.001).
The PACIFIER trial defined major adverse events as death, amputation or target
lesion revascularization. At 12 months, there were significantly fewer major
adverse events in the study arm as compared to the control arm (7.1 percent vs.
34.9 percent, p=0.003). All three of the major adverse events in the study arm
were target lesion revascularizations; the control arm included 15 target lesion
revascularizations and three deaths. None of the patients in the study had an
amputation.

IN.PACT Clinical Program

"With seven femoropopliteal trials featuring IN.PACT drug-eluting balloons
presented at medical meetings and five of them already published in peer-
reviewed journals, Medtronic is on track to deliver this technology to U.S.
physicians in a timely manner with an unprecedented volume of high-quality
clinical data to support its adoption," said Tony Semedo, senior vice president
of Medtronic, Inc. and president of the company's Endovascular Therapies
business.

The ongoing global IN.PACT clinical program includes 29 studies involving more
than 4,600 patients at approximately 230 sites worldwide. Through these company-
sponsored and physician-initiated studies, Medtronic's portfolio of IN.PACT
drug-eluting balloons will be investigated thoroughly for the treatment of
arterial disease in a variety of vessel beds. As part of this program, Medtronic
is currently enrolling the IN.PACT Global study, a first-of-its kind "real-
world" evaluation of the company's IN.PACT drug-eluting balloons involving
1,500 patients with femoropopliteal lesions of any length at up to 80 sites
worldwide.

IN.PACT drug-eluting balloons feature a proprietary coating called FreePac that
is a formulation of paclitaxel and urea, an excipient that facilitates
absorption of the drug into the vessel wall. They received the CE (Conformité
Européenne) mark in 2008 and 2009 and are available in many countries around the
world.

In the United States, the IN.PACT Admiral drug-eluting balloon is limited to
investigational use under an investigational device exemption (IDE) granted by
the FDA and, like every drug-eluting balloon, is not yet commercially available.

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. The company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers around the
world.

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 -


Contacts:
Joseph McGrath
Public Relations
+1-707-591-7367

Jeff Warren
Investor Relations
+1-763-505-2696




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Source: Medtronic, Inc. via Thomson Reuters ONE
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