FDA expands approval of Medtronic’s Solitaire stent retriever device
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.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.