JETi Hydrodynamic Thrombectomy System

The JETi Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration device designed to remove thrombus and emboli from peripheral blood vessels, including deep vein thrombosis (DVT). It uses a high-pressure saline jet within the catheter tip to macerate clots as they are aspirated, and can also deliver diagnostic or therapeutic fluids with or without vessel occlusion.

Both the JETi HTS and predicate device use a clot fragmentation mechanism based on aspiration combined with fluid jet delivery. While the JETi HTS and predicate (ZelanteDVT) have different clot fragmentation mechanisms and catheter size offerings, these technological differences do not raise different questions of safety and effectiveness. The JETi HTS is identical in design and performance characteristics to the reference device K232458.

Not stated in this summary.

The JETi HTS is substantially equivalent because both devices share the same intended use—removal of thrombi/emboli from and infusion of fluids into the peripheral vasculature including DVT—and operate on the same clot fragmentation principle (aspiration with fluid jet delivery). Although the Indications for Use differ slightly between devices, these differences do not alter the therapeutic intent or affect safety and effectiveness. The JETi Registry clinical data demonstrated the device met its primary effectiveness endpoint (84.5% achieving ≥75% thrombus reduction) and safety endpoint (1.7% major adverse events), supporting that the expanded DVT indication does not introduce new safety or effectiveness concerns relative to the predicate.