With advanced manufacturing capabilities, we develop embolic protection devices and inferior vena cava filters that meet stringent clinical requirements. Our technical experts match the highest-quality materials are matched to the precise design specifications and requirements of every structural heart component and structural heart device we manufacture.
We maintain ISO 13485 certification across our facilities, as well as quality and process management systems that meet the highest standards set by the United States Food and Drug Administration, the European Community, and other international regulatory authorities. Our technical experts ensure design for manufacturability to decrease development time, minimize costs, and achieve speed to market.
EPD Polymer Molding
Materials: Pellethane, Pebax, Polyimide, ePTFE, BioSpan®, Elast-Eon®
Processes: Thin polymer molding and dip coating
EPD Laser Hole Drilling
Hole Shapes: Round, parallelogram, hexagonal, other complex shapes
Processes: Hole ablation and drilling in a variety of pore sizes and configurations
EPD NiTi Wire Forming
Materials: Round, parallelogram, hexagonal, other complex shapes
Processes: Hole ablation and drilling in a variety of pore sizes and configurations
Inferior Vena Cava NiTi Wire Forming
Materials: Nickel titanium wire, laser-cut titanium tubes, 8-16 carrier braid
Processes: Filter basket forming utilizing a variety of manufacturing processes
Heat Setting of Nitinol
Heat setting of formed and expanded parts
Electropolishing
Electropolishing of small parts
Inferior Vena Cava Filter Assembly
Assembly / Joining Processes: Adhesive, swage, solder