EverFlex(TM) Peripheral Stent from Medtronic Delivers Sustained Patency in Long, Complex Lesions
April 01 2015 - 2:00PM
Three-Year Data
from DURABILITY II Study Published in
Catheterization and Cardiovascular Intervention
Journal
DUBLIN -- April 1, 2015 --
The EverFlex(TM) self-expanding peripheral stent system from
Medtronic plc (NYSE: MDT) has proven to provide sustained patency
in the treatment of long, complex lesions in the superficial
femoral (SFA) and popliteal arteries, according to the three-year
results of the DURABILITY II study, which are reported in the
recent issue of Catheterization and Cardiovascular
Intervention.
The EverFlex self-expanding stent system is a
nitinol stent system that expands to a predetermined diameter to
re-open narrowed (stenotic) regions of the SFA and proximal
popliteal arteries that supply blood to the legs. Narrowing of
these arteries is associated with a condition known as peripheral
arterial disease (PAD), where plaque builds along the lining of the
arteries, blocking blood flow to the legs.
"DURABILITY II is the first controlled study to
focus on treating long, complex lesions, and to specifically test
the use of a single nitinol stent in the SFA," said Dr. Krishna J.
Rocha-Singh, chief scientific officer, Prairie Heart Institute,
Springfield, Ill. "After 36 months, the durable patency and low
fracture rates support the validity of a single stent
strategy."
DURABILITY II, a prospective, multi-center,
non-randomized, single-arm study, enrolled 287 patients at 44
centers in the United States and Europe. The mean lesion length was
8.9 cm and included 48.1 percent occluded arteries with 43.2
percent severely calcified lesions. Subjects were followed annually
for three years with independent ultrasound core lab adjudicated
duplex ultrasound to determine stent patency, radiograms of the
stented extremity to assess stent fractures and ankle brachial
indices.
Duplex ultrasound-assessed patency (PSVR <2.0)
rate at three years was 60 percent; freedom from loss of primary
patency was significantly higher for lesions <=8 cm at 71
percent, compared to lesions >8 cm at 50.5 percent (p = 0.0001).
The three year freedom from target lesion revascularization (TLR)
was 70 percent. The three-year stent fracture rate was 0.9
percent.
"Restenosis and stent fractures are concerns when
treating long lesions in the SFA and proximal popliteal arteries,"
said Dr. Mark Turco, medical director for the Aortic and Peripheral
Vascular business, which is part of the Cardiac and Vascular Group
at Medtronic. "In the DURABILITY II study, the use of a single long
stent demonstrated the ability to achieve long-term vessel patency,
while minimizing the need for re-interventions."
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 diseases and cardiac arrhythmias. The
company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers
worldwide.
ABOUT MEDTRONIC
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, 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:
Krystin Hayward
Public Relations
+1-508-261-6512
Jeff Warren
Investor Relations
+1-763-505-2696
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information contained therein.
Source: Medtronic plc via Globenewswire
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