HARBOR Occlusion Device

The HARBOR Occlusion Device is a self-expanding nitinol mesh arterial embolization implant designed to block blood flow in peripheral arteries. It comes in 16 sizes ranging from 4.0 to 13.5 mm unconstrained outer diameter and is delivered through small microcatheters (0.017" or 0.027" inner diameter) under fluoroscopic guidance for treatment of peripheral arterial disease.

The device is a single-layer braided nitinol mesh with a platinum radiopaque marker band at the proximal end and a nitinol ball attachment point, featuring a 185 cm delivery system with mechanical detachment. Key differences from the predicate include: no micro screw attachment (uncoated nitinol ball instead), platinum core for improved radiopacity, smaller OD range (4.0–13.5 mm vs 4.0–16.0 mm), and use of e-beam sterilization rather than ethylene oxide.

ISO 10993 biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility); ISO 10993-18 extractables and leachables; ASTM hemolysis and corrosion resistance; mechanical bench testing including radial force, tensile strength, kink resistance, and simulated use; 90-day GLP animal study comparing subject device to predicate.

The Harbor device achieves substantial equivalence through identical intended use (arterial embolization in peripheral vasculature), same operating principle (self-expanding nitinol occlusion), similar design (single-layer braided mesh, cylindrical shape), comparable size ranges and vessel treatability, and equivalent or superior performance demonstrated by bench testing meeting radial force acceptance criteria, simulated use testing showing functional equivalence, biocompatibility meeting ISO 10993 requirements, and 90-day animal studies showing comparable effectiveness, safety, and durability to the predicate AMPLATZER devices.