The FDA expanded the approval of the Solitaire stent retriever device to treat patients with acute ischemic strokes.
Medtronic, which manufactures the Solitaire, announced the approval in a Nov. 16 news release.
The approval expands the use of the Solitaire 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 company said patients should use the Solitaire within six hours of symptom onset and after receiving intravenous tissue plasminogen activator (t-PA).
The approval was based on results of a study that found patients who used the Solitaire and received intravenous t-PA had a significant decrease in post-stroke disability. They were also more likely to be functionally independent within 90 days of the stroke.