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ANSWER Clinical Trial

Title: “Adjunctive Neurovascular Support for Wide-Neck Aneurysm Embolization and Reconstruction (ANSWER) Clinical Study”

Study Sponsor: Pulsar Vascular, Inc.

Principal Investigator: Matthew Lawson, MD

Study Synopsis:  The PulseRider® Aneurysm Neck Reconstruction Device is intended for use with embolic coils in the treatment of intracranial aneurysms originating on or near a vessel bifurcation of the basilar artery or carotid terminus artery with inflow vessel diameters from 2.7mm to 4.5mm.

This study is a prospective, multi-center, non-randomized study designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation intracranial aneurysms. Study assessments will be required from patients from the baseline visit up to 365-days post-procedure. The PulseRider® is a device that has been approved by the Food and Drug Administration (FDA) under an Investigational Device Exemption (IDE) and has a Humanitarian Use Device (HUD) designation. This designation is recognition that the device has a limited patient population of fewer than 4,000 individuals in the United Sates per year. The probable benefit to health outweighs the risks of injury or illness.

Study Status: Only for patients with an un-ruptured, intracranial bifurcating aneurysm of the basilar artery or carotid terminus artery.

For more information, contact Lutheria Hollis, CCRC, at (850) 201-2350

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