(268 days)
The ClotTriever Thrombectomy System is indicated for:
- · The non-surgical removal of thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath comprises a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter comprises reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.
The provided text describes the ClotTriever Thrombectomy System, its indications for use, and a clinical study (CLOUT Registry) conducted to support changes to its indications. However, the document does not contain a table of acceptance criteria and the device performance against those specific criteria. It outlines the results of a clinical registry and concludes that these results support the changes to the Indications for Use.
Therefore, many of the requested details cannot be fully extracted from the provided text. I will answer based on the information available and explicitly state when information is not present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of predefined acceptance criteria for the device's performance in a clinical study. Instead, it describes clinical outcomes observed in the CLOUT Registry, which are then used to justify the expanded Indications for Use.
| Performance Metric (Observed Outcome) | Reported Device Performance (CLOUT Registry) |
|---|---|
| Thrombus removal ≥75% (via core lab Marder scores) | 75.2% of treated limbs (including chronic disease) |
| Proportion of patients treated in a single session | 99.2% |
| Major adverse events through 30 days | 9 (6.8%) |
| Device-related major adverse events | 0 |
| Access-site hematoma | 1 (0.8%) |
| Acute renal injuries | 0 |
| Significant decrease in PTS patients (vs. baseline) | p |
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).