FDA expands indication of Solitaire device


The US Food and Drug Administration (FDA) has cleared an expanded indication for the Solitaire stent retriever device (Medtronic). The FDA now allows the marketing of the Solitaire device as an initial therapy for acute ischaemic 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 device should be used after patients have received intravenous tissue plasminogen activator (IV t-PA) and within six hours of symptom onset.

The FDA granted the expanded indication based upon a subset of data from the Solitaire FR with the intention for thrombectomy as primary endovascular treatment for acute ischemic stroke trial (SWIFT PRIME). 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 mRS scores of 0-2 within 90 days after a stroke (62.7% vs. 36.8%).

Earlier this year, the Safety and efficacy of Solitaire stent thrombectomy – Individual patient data meta-analysis of randomised trials (SEER), a meta-analysis of SWIFT PRIME, Endovascular revascularization with Solitaire device versus best medical therapy in anterior circulation stroke within 8 hours (REVASCAT), Extending the time for thrombolysis in emergency neurological deficits – intra-arterial (EXTEND-IA) and Endovascular treatment for small core and proximal occlusion ischemic stroke (ESCAPE), showed a strong significance in the numbers needed to treat (2.5) to reduce disability (ie., for every 2.5 patients treated with the Solitaire device plus IV-tPA, one patient showed improved functional outcomes).

“Stroke is the fifth leading cause of death in the USA and the number one cause of severe disability,” says Jeffrey L Saver, professor of Neurology, Geffen School of Medicine at the University of California, Los Angeles, USA and director, UCLA Comprehensive Stroke Center. “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.”