¹ TR18-001
² TR18-003
³ Kaneko N, Komuro Y, Yokota H, et al. J NeuroIntervent Surg. 2019;11:119–122. Testing per Kaneko and statements quoted refer to the VERSI Retriever. Articulating segmental design is substantially similar between the VERSI Retriever and ENVI^TM-SR Retriever.
⁴ TR20-001
⁵ TR22-001
⁶ IFU-020, see product labeling supplied with each device for additional information on compatibility
⁷ Virani SS, Alonso A, Benjamin EJ, et al.; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics – 2020 Update. Circulation, 2020 Mar 03;141:e139-e596.
⁸ GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol, 2019;18:439-58.
⁹ World Stroke Organization. Global Stroke Fact Sheet. These values have all been extracted from the Global Burden of Disease Stroke Statistics Worldwide for the year 2016.
¹⁰ V. Feigin et al. Global, Regional, and Country-Specific Lifetime Risks of Stroke, 1990 and 2016. New Engl J Med 2018;379:2429-2437

INTENDED USE
The Envi™-SR is intended for use to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom
onset. Patients who are ineligible for IV tPA or who fail IV tPA therapy are candidates for treatment.
CONTRAINDICATIONS
Use of the Envi™-SR is contraindicated under these circumstances:
• Patients with known hypersensitivity to nickel-titanium.
• Patients with angiographic evidence of carotid dissection.
WARNINGS
• Do not use if damage to the device is observed.
• Do not use if the product sterile barrier system or its packaging is compromised.
• Do not resterilize and/or re-use in multiple patients. Structural integrity, sterility and/or function may be impaired by resterilization or re-use.
• To reduce risk of device damage, vessel damage, and/or patient injury:
• Select the appropriate Envi™-SR based on the vessel size to be revascularized
• Do not perform more than 3 revascularization attempts in the same vessel.
• Do not deliver and retrieve the Envi™-SR more than 3 times.
• Do not torque the Envi™-SR.
• Monitor Envi™-SR positioning in vessel during exchange to prevent movement.
• Do not pull the Envi™-SR through a pre-existing stent or entanglement and vessel damage may occur.
PRECAUTIONS
• Carefully read these directions before using this product. Observe warning and safety precautions.
• For each new Retriever, use a new microcatheter.
• The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.
• The Envi™-SR should only be used by physicians experienced in angiographic and percutaneous neurointerventional procedures.
• Use device prior to Use-by date printed on label.
• Prevent exposure to temperatures in excess of 60°C. Exposure to temperatures above this temperature may damage device and accessories. Do not autoclave.
• To prevent thrombus formation and contrast media crystal formation, maintain a constant infusion of appropriate flush solution between guide catheter and
microcatheter and between the microcatheter and the Retriever or guidewire.
• Caution: Federal (USA) law restricts this device to sale, distribution and use by or on the order of a physician.
POTENTIAL COMPLICATIONS
Possible complications of the use of the Envi™-SR include, but are not limited to:
• Adverse reaction to antiplatelet/anticoagulation agents
or contrast media
• Air embolism
• Arteriovenous fistula
• Change in mental status
• Death
• Device deformation, collapse, fracture, or malfunction
• Distal embolization including to a previously
uninvolved territory
• Hematoma and hemorrhage at puncture site
• Infection
• Intracranial hemorrhage
• Ischemia
• Neurological deficits
• Neurological deterioration including stroke and
death
• Perforation or dissection of vessel
• Post procedural bleeding
• Pseudo aneurysm formation
• Thrombosis
• Vascular occlusion
• Vessel spasm