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.
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.
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These three words have the power to change lives. Between 8 to 10 million Americans are estimated to suffer from poor blood flow to the arms, legs and feet potentially leading to vascular disease, amputation or worse. Are you, or someone you know, suffering from Peripheral Arterial Disease (PAD)? Do you have pain in your legs when you walk at night, or even when resting? Do not ignore it. These warning signs are real and it’s time to get real help. Welcome to the LOVE YOUR LIMBS™ Campaign, by Bard Peripheral Vascular.