Medtronic Wins Expanded Indication For Solitaire Anti-Stroke Device

By Jof Enriquez,
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Medtronic says the U.S. Food and Drug Administration (FDA) has granted an expanded indication for the company's Solitaire stent retriever device for the initial treatment of acute ischemic stroke (AIS) to reduce stroke-related disabilities. FDA based its approval on data from the SOLITAIRE FR With the Intention For Thrombectomy as PRIMary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) clinical trial, which showed reduced post-stroke disability and increased functional independence among patients who were treated with the device.

"This expanded indication for the Solitaire device demonstrates Medtronic's ongoing dedication to significantly improving the lives of stroke patients," said Stacey Pugh, VP and GM of the Neurovascular business, which is part of the Restorative Therapies Group at Medtronic, in a news release. "As the only company with a device studied in all five of the global clinical trials responsible for changing the stroke treatment in the American Stroke Association guidelines (Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment), we have seen firsthand how stroke patients benefit from this treatment option."

FDA cleared in 2012, Solitaire and similar devices received a boost in 2015 when the American Heart Association (AHA) and the American Stroke Association (ASA) updated their guidelines recommending stent retriever devices as endovascular treatment for acute ischemic stroke in select patients. The groups based their decision on six clinical trials that showed how patients benefited from receiving these devices after a clot continued to obstruct a big vessel even after intravenous tissue plasminogen activator (IV t-PA) was given. Medtronic's Solitaire device was used in five of the six studies evaluated.

In February, the SEER global meta-analysis of four randomized trials, including 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 that patients over the age of 80 and in good health had a clinically and statistically significant 20 percent absolute reduction in mortality. Further, the analysis showed that patients experiencing an acute ischemic stroke and treated with the Solitaire device had significantly improved independent functional outcomes at 90 days than patients treated with IV-tPA alone.

According to iData Research, stroke, with 400,000 cases annually, is the fourth-leading cause of death in the United States, and is a leading cause of serious, long-term disability. Over 85 percent of strokes are ischemic strokes, caused by an obstructed artery that supplies blood to the brain.

Medtronic says about 240,000 people who suffer from acute ischemic stroke in the U.S. are eligible for treatment with stent retrievers. However, only 22,000 procedures are performed annually.