Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)

The Boomerang™ Valvulotome is a sterile, single-use intravascular catheter with a self-expanding nitinol basket and shielded blades, designed to disrupt or excise venous valves. It is intended for treating vascular disorders and is deployed by physicians in healthcare facilities with patient contact time under 24 hours.

Both the Boomerang and predicate (Expandable Lemaitre Valvulotome) use self-centering, self-sizing expandable nitinol baskets with blades deployed via luer hub. Key differences: Boomerang offers 80cm and 125cm lengths versus predicate's 40cm and 98cm; Boomerang has 4F shaft with 5mm basket diameter versus predicate's 4F shaft with 9.5mm basket diameter. Both are EO-sterilized.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ISO 10993-11 (acute systemic toxicity and pyrogenicity), ISO 10993-4 (hemolysis, PTT, complement activation, platelet and leukocyte assays). Testing also included dimensional verification, tensile strength, flexibility, torque, radiopacity, simulated use, corrosion resistance, and sterilization validation.

Substantial equivalence is based on identical intended use (valve disruption/excision), same mechanism of action (self-expanding nitinol basket with blades engaging valves), same materials and sterilization method (EO), and comparable design principles despite dimensional variations. The performance testing data across material properties, biocompatibility, and functional parameters demonstrate the Boomerang performs equivalently to the predicate device for its intended purpose.