Carotid embolic protection system TAVR

We provide a full range of solutions to support every phase of the product life cycle for TAVR embolic protection devices (EPD). Design and development of TAVR embolic protection devices. Transfer of products and processes from one site to another to support product-line transfer, line duplication, low-cost manufacturing, and prototype-to-production migration. Manufacture of finished embolic protection devices and components. Design for manufacturability (DFM) to assure that final products can be repeatedly manufactured while meeting quality, reliability, and performance requirements. Materials and Processes With advanced manufacturing capabilities, we develop embolic protection devices 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. Polymer Molding Materials: Pellethane, Pebax, Polyimide, ePTFE, BioSpan®, Elast-Eon® Processes: Thin polymer molding and dip coating Laser Hole Dripping Hole Shapes: Round, parallelogram, hexagonal, other complex shapes Processes: Hole ablation and drilling in a variety of pore sizes and configurations