Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices
The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices are self-expanding arterial occlusion plugs intended for use in the peripheral vasculature. The devices consist of the following components and are indicated to be a permanent implant: cobalt-chrome stem, nickel-titanium fibers, platinum-iridium radiopaque marker bands, and a polyurethane and polyethylene occlusion membrane. The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device Systems are packaged as a single unit with the implant, loader, dispenser hoop, detachable delivery wire, and torque tool. Innovative Dual-action Design for Rapid Occlusion * The Caterpillar and Caterpillar Micro Arterial Embolization Devices have an innovative dual-action design with opposing nitinol fiber segments and an occlusion membrane to help support rapid embolization and provide a balance between placement accuracy and deliverability in tortuous anatomy. * * In an arterial ovine Good Laboratory Practice (GLP) study with devices implanted according to labeled vessel diameters, full occlusion at 10 minutes was achieved with all Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices (14/14). Full occlusion defined as no perfusion – no antegrade flow beyond point of occlusion. Placement accuracy and track forces were measured through pre-clinical bench studies using either an anatomical splenic artery or right gastric artery model. Pre-clinical data and bench testing may not be indicative of clinical performance. Different test methods may yield different results. Data on file, Bard Peripheral Vascular, Inc. Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events, and detailed safety information.