(113 days)
-
The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
-
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.
-
The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age
The Trevo Retriever family, including the Trevo ProVue and Trevo XP ProVue Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever has a hydrophilic coating to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A torque device is provided with the Retriever to facilitate manipulation. The torque device is used to lock the core wire to the microcatheter during the procedure. Locking of the torque device to the wire allows the microcatheter and Retriever to be retracted as a system during clot retrieval. An insertion tool is provided to introduce the Retriever into a Microcatheter. The Insertion Tool is a sheath in which the Retriever comes preloaded. Once half the retriever's length is inserted into the microcatheter, the insertion tool is removed. Retrievers have a modified proximal end that permits attachment of the Abbott Vascular DOC Guide Wire Extension (REF 22260). Joining Guide Wire Extension to Retriever facilitates removal or exchange of a catheter while maintaining Retriever position in anatomy. After exchange has been completed, the extension can be detached.
Here's a breakdown of the acceptance criteria and study information for the Trevo Retriever, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a bulleted or numbered list with specific thresholds. Instead, the study aims to demonstrate superior clinical outcomes for the treatment arm compared to the control arm across several endpoints. The success thresholds are defined within the study design.
| Performance Metric (Acceptance Criteria) | Reported Device Performance (Treatment Arm vs. Control Arm) |
|---|---|
| Primary Effectiveness: | |
| 90-day Utility Weighted Modified Rankin Scale (UW-mRS): Posterior probability the Trevo thrombectomy increases expected scores relative to medical management alone, with a threshold for success of at least 0.986. | Mean UW-mRS: 5.5 (Treatment) vs. 3.4 (Control) |
| Posterior mean treatment benefit, core-adjusted: 2.0 (95% credible interval 1.1 to 3.0) | |
| Probability of superiority: > 0.9999 | |
| 90-day Dichotomized mRS (0-2 vs. 3-6) (Functional Independence): Success based on the same model and hierarchical fashion as UW-mRS. | Functional Independence (mRS 0-2): 48.6% (Treatment) vs. 13.1% (Control) |
| Posterior treatment benefit, core-adjusted: 32.8% (95% credible interval 21.1% to 44.1%) | |
| Probability of superiority: > 0.9999 | |
| Primary Safety: | |
| Incidence of stroke-related mortality at 90 days: No significant difference between study arms. | Treatment Arm: 15.9% (17/107) vs. Control Arm: 18.2% (18/99) |
| Difference: -2.3% [-12.6%, 8.0%] | |
| p-value = 0.7126 (No significant difference) | |
| Secondary Effectiveness: | |
| Early Neurological Response (Day 5-7/Discharge): Defined as NIHSS drop of ≥ 10 points or NIHSS score of 0 or 1. | Treatment Arm: 47.7% vs. Control Arm: 19.2% |
| Mean Absolute Difference: 28.5% (16.2%, 40.7%) | |
| Risk Ratio: 2.5 (1.6, 3.9) | |
| **P-Value: |
§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.