Solitaire™ FR Revascularization Device
Restore. Retrieve. Revive.
According to the American Heart Association, each year about 795,000 people in the U.S. experience a new or recurrent stroke. Ischemic stroke occurs as a result of a clot blocking the flow of blood to the brain and is the most common type of stroke, accounting for approximately 690,000 or 87% of all strokes. The time to treatment is a key component in determining the degree of injury to a patient’s brain. Restoring blood flow as quickly as possible is a critical objective in treating a blocked vessel in the brain.
The Solitaire FR Flow Restoration System is a catheter-based thrombectomy system based on ev3’s fully retrievable Solitaire stent platform and combines the ability to revascularize and retrieve the clot in a single device. The device is designed to be passed through the obstruction and deployed, thereby offering the potential for flow restoration and the ability to retrieve clot in patients experiencing acute ischemic stroke. The Solitaire FR device has the CE Mark and is available outside the U.S.
We are currently enrolling patients in our SWIFT (Solitaire With the Intention For Thrombectomy) U.S. IDE randomized trial comparing recanalization rates of the Solitaire FR Flow Restoration device and the Concentric Medical Merci Retriever® device in the treatment of acute ischemic stroke. The SWIFT study is designed to enroll 200 patients at 20 centers in the U.S. and one European center. The study will measure arterial recanalization of the occluded target vessel without any symptomatic intracranial hemorrhage, time to achieve initial recanalization and assess patient neurological condition at 90 days.
The ev3 Solitaire FR Revascularization Device is designed for use in the flow restoration of patients with ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Solitaire FR Revascularization Device is for investigational use only in the United States.
Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.
Print
