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Stent LIFESTENT® Vascular Stent System

An Approved SFA Stent for Sustained Long-Term Outcomes.
The SFA and proximal popliteal arteries are common areas of blockage in patients with PAD. The LIFESTENT® Vascular Stent is the first FDA-approved stent for use in the superficial femoral artery (SFA) and proximal popliteal artery. The LIFESTENT® Vascular Stent has an advanced helical design for unmatched SFA outcomes as compared to standard PTA.

RESILIENT Clinical Study
The LIFESTENT® Vascular Stent clinical trial showed that 75% of treated patients did not need revascularization of the treated lesion at three years (n=206).

Treating the SFA

The superficial femoral artery is subject to four forces: bending, axial compression, torsion and external compression. The LIFESTENT® Vascular Stent is designed for and proven in the SFA and proximal popliteal.


Safety information

LIFESTENT® Vascular Stent System

Indication for Use: The LIFESTENT® Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and proximal popliteal artery with reference vessel diameters ranging from 4.0-6.5 mm.

Contraindications:The LIFESTENT® Vascular Stent System is contraindicated for use in: Patients with a known hypersensitivity to nitinol (nickel, titanium), and tantalum, patients who cannot receive recommended anti-platelet and/or anti-coagulation 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.

Adverse Events: Potential adverse events that may occur include, but are not limited to, the following: Allergic/anaphylactoid reaction, Amputation, Aneurysm, Angina/coronary ischemia, Arterial occlusion/thrombus, near the puncture site, Arterial occlusion/thrombus, remote from puncture site, Arterial occlusion/restenosis of the treated vessel, Arteriovenous fistula, Arrhythmia, By-pass Surgery, Death related to procedure, Death unrelated to procedure, embolization, arterial, embolization, stent, fever, hemorrhage/bleeding requiring a blood transfusion, hematoma bleed, remote site, hematoma bleed at needle, device path: nonvascular procedure, hematoma bleed, puncture site: vascular procedure, hypotension/hypertension, incorrect positioning of the stent requiring further stenting or surgery, intimal injury/dissection, ischemia/infarction of tissue/organ, Liver failure, Local infection, Malposition (failure to deliver the stent to the intended site), Open surgical repair, Pain, Pancreatitis, Pulmonary embolism/edema, Pneumothorax, Pseudoaneurysm, Renal failure, Respiratory arrest, Restenosis, Septicemia/bacteremia, Stent fracture, Stent Migration, Stroke, Vasospasm, Venous occlusion/thrombosis, remote from puncture site, Venous occlusion/thrombosis, near the puncture site.

Three primary components that have the potential to reduce the risk of amputation even in advanced stages of Critical Limb Ischemia (CLI).

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