Medtronic Launches Lower-Extremity Indication for Complete 'SE' Vascular Stent Internationally

Thu Jan 24, 2013 6:00am EST

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Self-Expanding Peripheral Device Gets CE Mark 
for Superficial Femoral and Proximal Popliteal Arteries

MINNEAPOLIS -- Jan. 24, 2013 -- Expanding its role in the treatment of peripheral artery disease,
Medtronic, Inc. (NYSE: MDT) today announced the CE (Conformité Européene) mark and international
launch of its Complete SE (self-expanding) vascular stent for use in the lower extremities --
specifically, the superficial femoral arteries (SFA) and proximal popliteal arteries (PPA), which
supply blood to the legs.

In the United States, the Complete SE stent is approved by the U.S. Food and Drug Administration
(FDA) only for use in the iliac arteries, which supply blood to the pelvis and legs. Its use in
lower-extremity arteries in the United States is under review by the FDA. Previously CE marked
only for use in the iliac arteries, the Complete SE stent can now be used internationally in the
lower extremities as well. 

The new indication was obtained after clinical data from the Complete SE SFA study -- an
independently adjudicated single-arm, multicenter trial that enrolled 196 patients at 28 sites in
the United States and Europe -- showed a low clinically-driven target lesion revascularization
(i.e. repeat procedure) rate of 8.4 percent at 12 months. Additionally, and unique among similar
studies utilizing bare-metal stents in this vessel bed, there were no (0.0 percent) stent
fractures at 12 months in the study. 

These outcomes were achieved despite the challenging nature of the patient population represented:

*45 percent of the patients had diabetes.
*50 percent of the lesions were located in the distal segment of the superficial femoral /proximal
popliteal artery.
*56 percent of the lesions were defined as highly calcified.
*67 percent of patients had a Rutherford Category rating of three or higher.

The Complete SE SFA study showed statistically significant improvements in multiple measures of
clinical and functional effectiveness: 

*More than 80 percent of study subjects had achieved a Rutherford Category value of 0 or 1, the
favorable end of the 0-6 scale, at 30 days, and that benefit persisted through six months and one
year of follow-up. 
*Treatment with the Complete SE stent also resulted in highly significant positive shifts in mean
ankle brachial index (ABI) or toe brachial index (TBI) scores at six and 12 months, with 65
percent of study subjects improving by at least 0.15 percent over the follow-up period. 
*On Walking Assessment measures, impairment improved by 37 percent, distance by 33 percent, speed
by 22 percent and stair climbing by 23 percent.

"The Complete SE stent not only delivers compelling clinical results, but its unique features and
delivery system offer an ease-of-use unparalleled with other devices designed to treat
lower-extremity lesions," said Prof. Dierk Scheinert, chairman of the Center for Vascular Medicine
at Part Hospital in Leipzig, Germany. 

With risk factors including smoking, diabetes, obesity, high blood pressure, high cholesterol, age
(50 or older) and familial history, peripheral artery disease narrows the vessels that supply
blood to the body, especially the limbs. Typically characterized by an excessive buildup of plaque
in these vessels, the condition can progress without treatment to critical limb ischemia, which
often leads to amputation and premature death.  

A variety of treatments are used to restore normal blood flow in patients with peripheral artery
disease. Stents are metallic scaffolds used to improve blood flow by expanding the interior
diameter of narrowed arteries. They are implanted in a minimally invasive procedure that uses
catheters to access the arterial segment requiring treatment. 

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

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 results. 

- end -


Joseph McGrath
Public Relations

Jeff Warren
Investor Relations


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Source: Medtronic, Inc. via Thomson Reuters ONE