Nitinol Enhanced Device (NED)

The Nitinol Enhanced Device (NED) is a vascular embolization system intended for arterial and venous occlusion in peripheral blood vessels (3–6 mm diameter). It consists of polymer-based implants with thrombogenic fibers, a nitinol pusher delivery system, and a transfer/removal tool, designed to obstruct blood flow through mechanical obstruction and thrombus formation.

The NED uses radiopaque polymer implants with UHMWPE external braid and thrombogenic tails, deployed via a 0.022-inch nitinol wire pusher through 0.027-inch microcatheters. The predicate Interlock-18 uses platinum with thrombogenic tails and a 0.021-inch microcatheter. Both employ interlocking-arm detachment mechanisms and are MR-conditional up to 3.0 Tesla. The NED targets smaller vessel diameters (3–6 mm) with three implant sizes, whereas the predicate covers a wider range (2–22 mm).

ASTM F2129 and ASTM F3044 (nitinol corrosion); ISO 10993-1 (biocompatibility); delivery and deployment force testing; detachment mechanism testing; MRI compatibility; CT artifact evaluation; GLP acute and subchronic ovine studies; packaging integrity and shelf-life validation.

The NED is substantially equivalent because it shares the same intended use (peripheral vascular embolization), classification (Class II, KRD), and basic operating principle (mechanical obstruction plus thrombogenic fiber-induced clotting) as the Interlock-18 predicate. Although materials differ (polymer vs. platinum) and the NED targets a narrower vessel range, it uses comparable thrombogenic fibers, identical interlocking detachment mechanisms, and equivalent MR safety. Non-clinical testing—including biocompatibility, deployment mechanics, and animal safety studies—supports performance parity, and no human clinical data was required because the indications are equivalent.