(102 days)
The Solitaire™ 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.
The Solitaire™ 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. The device is intended for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The device is a nitinol self-expanding, fully retrievable, stent-based design that allows for clot retrieval when deployed in occluded target vessels after acute ischemic stroke. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers for visualization on the proximal and distal ends. The device is supplied sterile and is intended for single-use only by physicians trained in interventional neuroradiology and treatment of ischemic stroke.
Here's a summary of the acceptance criteria and study findings for the Solitaire™ FR Revascularization Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the non-inferiority study design comparing the Solitaire FR device to the predicate Merci Retriever.
| Metric (Implied Acceptance Criterion) | Predicate Device (Merci Retriever) Performance | Solitaire™ FR Device Performance | Conclusion (Does it meet acceptance criteria?) |
|---|---|---|---|
| Primary Effectiveness Endpoint: Successful recanalization measured by TIMI flow without symptomatic hemorrhage (non-inferiority to Merci) | 24.1% (13/54) | 60.7% (34/56) | Yes, met non-inferiority (p |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).