(126 days)
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus 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.
Like the predicate device, the Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end and is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. A radiopaque coil at the distal end allows fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The study aimed to demonstrate the non-inferiority of the Trevo Retriever compared to the predicate Merci Retriever.
Table 1: Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance (Non-Inferiority Margin) | Trevo Retriever Performance (vs. Merci) | Met? |
|---|---|---|---|
| Primary Efficacy Endpoint: Post-Device Revascularization Success (TICI ≥2a) | Non-inferiority margin of 10% | Trevo: 87.3% (69/79) | |
| Merci: 58.0% (47/81) | |||
| Difference: 29.3% (95% CI: 15.0%, 42.4%) | |||
| *p-value |
§ 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).