FDA Okays Expanded Indication for Solitaire Stent Retriever

Pauline Anderson


November 17, 2016

The US Food and Drug Administration (FDA) has cleared an expanded indication for the Solitaire stent retriever device, Medtronic has announced.

The move will allow the marketing of the device as an initial therapy for acute ischemic strokes for patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts to reduce paralysis, speech difficulties, and other stroke-related disabilities.

The Solitaire stent retriever device uses a micro-sized catheter to access arteries in the brain, helping to restore blood flow and remove large blood clots causing acute ischemic stroke. It should be used after patients have received intravenous tissue plasminogen activator (IV tPA) and within 6 hours of symptom onset.

The FDA granted the expanded indication on the basis of a subset of data from the SWIFT-PRIME (Solitaire FR With the Intention For Thrombectomy as PRIMary Endovascular Treatment for Acute Ischemic Stroke) study.

The data demonstrate that the addition of the Solitaire device to IV tPA significantly decreased post-stroke disability and increased the number of patients who were functionally independent, with modified Rankin Scale scores of 0 to 2 within 90 days after a stroke (62.7% vs 36.8%), the release notes.

Solitaire stent retriever device

Several studies — SEER (Safety and Efficacy of Solitaire Stent Thrombectomy–Individual Patient Data Meta-analysis of Randomized Trials), a meta-analysis of SWIFT PRIME, REVASCAT (Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours), EXTEND-IA (EXtending the Time for Thrombolysis in Emergency Neurological Deficits – Intra-Arterial), and ESCAPE (Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke) — have shown strong significance in the numbers needed to treat (2.5) to reduce disability: For every 2.5 patients treated with the Solitaire device plus IV tPA, 1 patient showed improved functional outcomes.

"The availability and access to a technology that reduces stroke disability is critically important because with such innovations, stroke patients and their families may experience less physical, emotional and financial burdens from their condition," commented Jeffrey L. Saver, MD, professor of neurology, Geffen School of Medicine, University of California, Los Angeles, and director, UCLA Comprehensive Stroke Center, who led much of the Solitaire investigation, in the press release.

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