Medtronic's Solitare Stent Retriever Receives Expanded Indication from FDA

Medtronic (NYSE:MDT) today announced that the FDA has approved marketing their Solitaire Stent Retriever for treating acute ischemic strokes.
According to the press release:

The FDA granted the expanded indication based upon a subset of data from the SOLITAIRE(TM) FR With the Intention For Thrombectomy as PRIMary Endovascular Treatment for Acute Ischemic Stroke trial (SWIFT PRIME)2. The data demonstrates that the addition of the Solitaire device to IV-tPA significantly decreased post-stroke disability and increased the number of patients who were functionally independent with mRS scores of 0-2 within 90 days after a stroke (62.7% vs. 36.8%).

Stacey Pugh, VP of Medtronic’s Neurovascular division, said the following:

“This expanded indication for the Solitaire device demonstrates Medtronic’s ongoing dedication to significantly improving the lives of stroke patients. 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 guidelines1 (Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment), we have seen firsthand how stroke patients benefit from this treatment option.”

Read the full press release here.