We provide a full range of solutions to support every phase of the product life cycle of diagnostic mapping catheters.
Design and development of complex diagnostic mapping catheters including diagnostic EP catheters, high-density mapping catheters and ICE catheters.
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 completed diagnostic mapping catheters as well as custom medical device components, including polyimide-coated wire, high-spring constant coils, steerable braided shafts, polyimide tubing, braided multi-lumen extrusions, PT electrodes and marker bands, welded electrode assemblies, coated stainless wire-welded pull cables, thermocouples, micro-molding, and machined and molded handles.
Design for manufacturability (DFM) to assure that final products can be repeatedly manufactured while meeting quality, reliability, and performance requirements.
Clinical and regulatory expertise; understanding of emerging clinical trends through our physician advisory board; preclinical product evaluation; validated mechanical and electrical test methods; and medical device registration, reporting, and vigilance.
Materials and Processes
With comprehensive manufacturing capabilities, we develop diagnostic mapping catheters in a wide range of models and configurations. Our technical experts ensure the highest-quality materials are matched to the precise design specifications and requirements of every component and device we manufacture.