The clearance allows Meditronic to market the device as an initial therapy for acute ischemic strokes (AIS) for patients with persistent, proximal anterior circulation, large vessel occlusion and smaller core infracts to control paralysis, speech difficulties and other stroke-associaated disabilities.
The Solitaire device can be used after patients have received intravenous tissue plasminogen activator (IV t-PA) and within six hours of symptoms showing up.
The expanded indication was granted based on a subset of data from the study, SOLITAIRE FR With the Intention For Thrombectomy as PRIMary Endovascular Treatment for Acute Ischemic Stroke trial (SWIFT PRIME).
The showed that by adding Solitaire device to IV-tPA, the chance of post-stroke disability was reduced significantly and the number of patients who were functionally independent with mRS scores of 0-2 within 90 days after a stroke, also increased (62.7% vs. 36.8%).
Medtronic Restorative Therapies Group, Neurovascular business vice president and general manager, Stacey Pugh said: "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 guidelines (Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment), we have seen first-hand how stroke patients benefit from this treatment option."
Image: Medtronic’s Solitaire Stent receives expanded indication from USFDA. Photo: Courtesy of Medtronic plc.
