- 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.