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|EverFlex(TM) Peripheral Stent from Medtronic Delivers Sustained Patency in Long, Complex Lesions|
Three-Year Data from DURABILITY II Study Published in
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.
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.
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