2013-09-24 15:02:01 -
New Indications for Self-Expanding Device Address Broad Area of Peripheral
MINNEAPOLIS -- September 24, 2013 -- Expanding its role in the treatment of
peripheral artery disease in the United States, Medtronic, Inc. (NYSE: MDT)
announced today that the U.S. Food and Drug Administration (FDA) has approved
the Complete SE (self-expanding) vascular stent for use in the lower extremities
-- specifically, the superficial femoral artery (SFA) and proximal popliteal
artery (PPA), which carry blood through the upper legs.
The same device was originally approved by the FDA for use in the iliac
arteries, which perfuse the
pelvis. It also has the CE (Conformité Européene)
mark for iliac and, most recently, for SFA and PPA indications.
FDA approval of the new SFA and PPA indications was supported by the results of
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. The study showed a clinically-driven target lesion revascularization
(repeat procedure) rate of 8.4 percent at 12 months, which is among the best
performances in clinical trials of contemporary self-expanding peripheral stents
for the treatment of SFA/PPA lesions.
Additionally, there were no in-hospital major adverse events (MAE) among study
patients, and the total MAE rate at 12 months was 11.0 percent. The Kaplan-Meier
estimate of primary patency at 360 days was 90.9 percent; at the time of the
last duplex ultrasound assessment, at 553 days, primary patency was 72.5
percent. No stent fractures occurred through 12 months.
The study also showed statistically significant improvements in multiple
measures of clinical and functional effectiveness:
* More than 80 percent of the patients had achieved a Rutherford
classification 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.
* On walking assessment measures at 12 months, absolute improvement in
impairment was 37 percent, distance was 32 percent, speed was 22 percent and
stair climbing was 23 percent.
* 65 percent of the patients showed an improvement of 0.15 or more on their
ankle-brachial index (ABI) or toe-brachial index (TBI) scores over the 12-
month follow-up period. The mean ABI/TBI score at 12 months was 0.9.
These outcomes were achieved despite the challenging nature of the patient
* 45 percent of the patients had diabetes, and 67 percent had a Rutherford
classification of 3 or higher at baseline.
* 50 percent of the treated lesions were located in the distal segment of the
artery, and 91 percent were moderately or highly calcified.
"The Complete SE vascular stent has demonstrated compelling clinical results in
this study, which included a broad spectrum of patient and lesion types," said
primary investigator Dr. John Laird, medical director of the UC Davis Vascular
Center near Sacramento. "It is also among the most deliverable and easy-to-use
devices of its kind."
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 to claudication and, 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. These tubular
medical devices 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, 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 worldwide.
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
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Source: Medtronic, Inc. via Thomson Reuters ONE