Stent Retrievers
SolitaireTM FR Revascularization Device
Indications for Use
The SolitaireTM FR Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke 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.
Key Specifications
- Nitinol self-expanding, fully retrievable, stent-based design
- Distal nitinol portion for clot retrieval
- Pt-Ir radiopaque markers on proximal and distal ends
- Materials: Nitinol device and push wire, 90% Platinum/10% Iridium distal marker coils, Stainless steel wire (Parylene coated), Dymax adhesive, PTFE push wire shrink tubing, PTFE/Grilamid introducer sheath
- Supplied sterile and intended for single-use only
- Intended for use in neurovasculature: internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and vertebral arteries
- Overall rate of successful clot retrieval: 96.2% in in vitro tortuous anatomical model
Description
The SolitaireTM FR Revascularization Device is a nitinol self-expanding, fully retrievable, stent-based design intended to restore blood flow by removing thrombus from large intracranial vessels in patients experiencing ischemic stroke within 8 hours of symptom onset. It is for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and vertebral arteries. The distal nitinol portion facilitates clot retrieval and includes Pt-Ir radiopaque markers for visualization. The device is supplied sterile for single-use by trained physicians in interventional neuroradiology.