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Stent retriever device receives FDA approval for extended use
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The FDA has cleared an expanded indication for a stent retriever from Medtronic that will allow the marketing of the device as an initial therapy for acute ischemic strokes, according to a company press release.
The device (Solitaire) is recommended for patients with a persistent, proximal anterior circulation, large vessel occlusion and small core infarcts to reduce stroke-related disabilities. The device should be used within 6 hours of symptom onset and after patients have received IV tissue plasminogen activator.
“Stroke is the fifth leading cause of death in the U.S. and the No. 1 cause of severe disability,” Jeffrey L. Saver, MD, FAHA, FAAN, FANA, professor of neurology at the Geffen School of Medicine at UCLA and director of UCLA Comprehensive Stroke Center, said in the release. “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.”
The latest data from the SWIFT PRIME trial showed that the addition of the stent retriever device to IV tissue plasminogen activator significantly decreased poststroke disability and increased the number of patients functionally independent.