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Clinical evidence

EverFlex™ Stent System with Entrust™ Delivery System

DURABILITY II is the first controlled study to focus on treating long, complex lesions and to specifically test the performance of a single long stent in the superficial femoral artery. Read more about the DURABILITY II clinical study in these published, peer-reviewed journal articles

Indications, Safety, and WarningsNote: Safety information provided is for the United States. Please refer to your region’s instructions for use for specific details.This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at 1-763-514-4000 (Worldwide). Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions. IndicationsThe EverFlex™ self-expanding peripheral stent system is intended to improve luminal diameter in the treatment of symptamotic de novo or restenotic lesions up to 180 mm in length in the native superficial femoral artery and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm–7.5 mm. The EverFlex™ self-expanding peripheral stent system is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to and including 100 mm in length, with a reference vessel diameter of 4.5 mm–7.5 mm.The Protégé™ EverFlex™ self-expanding biliary stent system is intended as a palliative treatment of malignant neoplasms in the biliary tree.ContraindicationsUse of the EverFlex™ self-expanding peripheral stent system is contraindicated in patients with known hypersensitivity to nickel titanium and in patients contraindicated for anticoagulant and/or antiplatelet therapy, patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.Potential adverse eventsPotential adverse events which may be associated with the use of a stent in the SFA and proximal popliteal arteries include, but are not limited to: allergic reaction, amputation, artery perforation or rupture, bleeding requiring transfusion, infection, pseudoaneurysm, restenosis, stent collapse or fracture, stent migration, surgical or endovascular intervention, or thrombosis/occlusion of the stent.See the instructions for use provided with the product for a complete list of warnings, precautions, adverse events and device information.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.FTSOP113326-40 Rev. 1AUC201712541cEN

DURABILITY II — Primary 1-Year

The United States Study for Evaluating Endovascular Treatments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By using the Protégé EverFlex Nitinol Stent System II (DURABILITY II).

Matsumura JS, et al. J Vasc Surg. 2013;58:73–83.e1.

DURABILITY II — Primary 3-Year

A Single Stent Strategy in Patients with Lifestyle Limiting Claudication: 3-Year Results from the DURABILITY II Trial.

Rocha-Singh KJ, et al. Catheter Cardiovasc Interv. 2015;86:164–170.

DURABILITY II — Gender 1-Year

The Impact of Sex on Angioplasty and Primary Stenting for Femoropopliteal Occlusive Disease: Results of the DURABILITY II Trial.

Tedros RO, et al. Ann Vasc Surg. 2014;28:1–9.

DURABILITY II — Gender 3-Year

Intermediate Outcomes of Femoropopliteal Stenting in Women: 3-Year Results of the DURABILITY II Trial.

Han DK, et al. Ann Vasc Surg. 2016;30:110–117.

DURABILITY 200 — Long lesions

Results of the Protégé EverFlex 200-mm-long Nitinol Stent (ev3) in TASC C and D Femoropopliteal Lesions.

Bosiers M, et al. J Vasc Surg. 2011;54:1042–1050.

Related links

Resources

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Peripheral Product Catalogue (open in new window)

Choose from a full portfolio of peripheral products for endovascular interventions — products that help you reach your PAD patient treatment goals.

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