Optima Coil System (OptiOne Coil System)

The Optima Coil System (OptiOne Coil System) is a series of specialized platinum-tungsten coils delivered via pusher assembly into blood vessels under radiographic guidance to embolize (block) intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae, and other vascular abnormalities in the neuro and peripheral vasculature. The coils are placed to create blood stasis and permanently obstruct blood flow to the lesion.

The subject device implements an updated implant design featuring helical loops and complex box geometries for improved anchoring into aneurysms, reducing the need for additional coiling. Secondary shape diameters expanded to 3–6 mm (versus 2 mm predicate), coil wire diameter expanded to 0.00125"–0.002" (versus 0.00125"–0.0015" predicate), and coil length narrowed to 5–37 cm (versus 3–65 cm predicate). All other components, materials (92/8 Pt/W alloy), sterilization method, and delivery mechanism remain identical.

Not stated in this summary.

The subject OptiOne Coil System is substantially equivalent to predicate device K252700 because there is no change to intended use, materials, principles of operation, or performance requirements. Bench testing including visual inspection, dimensional verification, resistance checks, and simulated use all passed established acceptance criteria. The design improvements do not raise new questions of safety and effectiveness.