STAT SOLITAIRE THROMBECTOMY + ASPIRATION THERAPY

INNOVATING FASTER TO ADVANCE OUTCOMES —
WITH STAT, WE CAN TAKE AIS TREATMENT FURTHER, TOGETHER.

Solitaire^™ Platinum Revascularization Device
INDICATIONS 1. The Solitaire™ Platinum Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset. 2. The Solitaire™ Platinum Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment. CONTRAINDICATIONS Use of the Solitaire™ Platinum Revascularization Device is contraindicated under these circumstances. ∙ Patients with known hypersensitivity to nickel-titanium. ∙ Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the Solitaire™ Platinum Revascularization Device. ∙ Patients with angiographic evidence of carotid dissection. WARNINGS – BOTH INDICATIONS ∙ The appropriate anti-platelet and anticoagulation therapy should be administered in accordance with standard medical practice. ∙ Per IV t-PA manufacturer labeling, IV t-PA should be administered within 3 hours of stroke symptom onset (IV t-PA use beyond 3 hours is not approved in the United States). ∙ Do not torque the Solitaire™ Platinum Revascularization Device. ∙ For vessel safety, do not perform more than three recovery attempts in the same vessel using Solitaire™ Platinum Revascularization Devices. ∙ For device safety, do not use each Solitaire™ Platinum Revascularization Device for more than two flow restoration recoveries. ∙ For each new Solitaire™ Platinum Revascularization Device, use a new microcatheter. ∙ Solitaire™ Platinum Revascularization Device does not allow for electrolytic detachment. ∙ To prevent device separation: Do not oversize device; Do not recover (i.e. pull back) the device when encountering excessive resistance. Instead, resheath the device with the microcatheter and then, remove the entire system under aspiration. If resistance is encountered during resheathing, discontinue and remove the entire system under aspiration; Do not treat patients with known stenosis proximal to the thrombus site. ∙ This device is supplied STERILE for single use only. Do not reprocess or re-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance. ∙ Operators should take all necessary precautions to limit X ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible. WARNINGS – INDICATION 1 ONLY ∙ The safety and effectiveness has not been established for the Solitaire™ Platinum device to reduce disability in patients with the following: Posterior circulation occlusions; More distal occlusions in the anterior circulation; Large core infarct (ASPECTS ≤7).

React^™ Catheter
INDICATION The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Riptide™ Aspiration System
INDICATION The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.