ELANA Study |
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The ELANA technique has been used in Europe since 1993 in approximately 400 clinical procedures. The objective of this prospective, nonrandomized, international, FDA approved, multi-center Study is to confirm the clinical experience in Europe and demonstrate the safety and efficacy of the Elana Arteriotomy System in creating an intracranial arteriotomy in a nonocclusive manner. Centers will enroll patients who require a temporary or permanent bypass to be connected to one or more unoccluded intracranial vessel(s) for an established indication and for whom the responsible surgeon feels they cannot be safely treated otherwise e.g., because of a lesion not ideal for coiling or clipping or excision or temporary or permanent occlusion of a vessel without the temporary or permanent creation of a bypass. |
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Physicians within the referral areas of the participating centers are being asked for their help in identifying patients who meet the inclusion/exclusion criteria. |
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