Prestige Coil System (Prestige Packing Line Extension)

The Prestige Coil System is a family of embolic coils with delivery system components that are inserted through blood vessels to block abnormal vascular areas in the peripheral vasculature. The coils are permanently placed to stop blood flow and create clotting at the target site. It is indicated for arterial and venous embolizations in peripheral blood vessels.

The modified device implements an updated implant design that grabs and anchors into previously packed coils while reducing resistance and improving navigability through tortuous vessels. It also features a more robust pusher with increased strength and stiffness to improve navigation and visibility during deployment. The coil length changes from 1-65 cm to 10-65 cm, primary wind diameter is fixed at 0.014 inches, secondary shape diameter is 2 mm (vs. 1-24 mm), and wire diameter is 0.0015-0.002 inches (vs. 0.00125-0.003 inches). All other materials, construction methods, and system components remain identical to the predicate.

Not stated in this summary.

The device maintains identical intended use, indications, materials (92/8 Pt/W alloy), principles of operation, and performance requirements as the predicate K220699. The modifications to implant design and pusher robustness are refinements that improve clinical performance (navigation, anchoring, visibility) without introducing new safety or effectiveness questions. Non-clinical bench testing including visual inspection, dimensional verification, and simulated use testing confirmed the modified device meets established acceptance criteria and performs equivalently to the predicate in a clinically relevant model.