FDA OKs Solitaire for Initial Therapy to Reduce Stroke-Related Disability

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

The Solitaire device can now be marketed as an initial therapy for acute ischemic strokes (AIS) for patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts to reduce stroke-related disabilities such as paralysis and speech difficulties. It should be used after patients receive intravenous tissue plasminogen activator (IV t-PA) and within 6 hours of symptom onset.  

The expanded indication is based on data from the SWIFT PRIME trial, which demonstrated that the addition of the Solitaire device to IV-tPA significantly reduced post-stroke disability and increased the amount of patients who were functionally independent with mRS scores of 0–2 within 90 days after a stroke (62.7% vs. 36.8%).

Other studies of the Solitaire device (SEER, REVASCAT, EXTEND-IA, and ESCAPE) have shown that the number needed to treat to reduce disability was 2.5.

The Solitaire device uses a micro-sized catheter to access arteries in the brain to restore blood flow and remove large clots which cause AIS.

For more information visit Medtronic.com.