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PULSERIDER Aneurysm Neck Reconstruction Device:
HUMANITARIAN DEVICE (USA ONLY): Authorized by Federal law for use with neurovascular embolic coils in patients ≥ 18 years of age for the treatment of unruptured wide-necked intracranial aneurysms with neck widths ≥ 4 mm or a dome to neck ratio < 2 originating on or near a vessel bifurcation of the basilar tip or carotid terminus with at least a portion of the aneurysm neck overlapping the lumen of the parent artery. The inflow vessels should have diameters from 2.7 mm to 4.5 mm. The effectiveness of this device for this use has not been demonstrated.
As with any surgical procedure, the treatment of stroke by either filling an aneurysm with coils (with or without a stent) or the mechanical removal of blood clot may present risks. Patients should consult with their doctors to discuss whether these types of procedures may be appropriate for them.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications side effects, warnings and precautions.
Caution: US law restricts this device to sale by or on the order of a physician.
Pulsar Vascular, Inc.
130 Knowles Drive
Los Gatos, CA 95032