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 ENVITM-SR Retriever.
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
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.
Use of the Envi™-SR is contraindicated under these circumstances:
• Patients with known hypersensitivity to nickel-titanium.
• Patients with angiographic evidence of carotid dissection.
• 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.
• 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.
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
• Device deformation, collapse, fracture, or malfunction
• Distal embolization including to a previously
• Hematoma and hemorrhage at puncture site
• Intracranial hemorrhage
• Neurological deficits
• Neurological deterioration including stroke and
• Perforation or dissection of vessel
• Post procedural bleeding
• Pseudo aneurysm formation
• Vascular occlusion
• Vessel spasm