We provide a full range of solutions to support every phase of the product life cycle of device delivery system catheters for TAVR, TMVR and LAA procedures.
Design and development of device delivery system catheters to accommodate a range of sizes up to 35 Fr.
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 standard and custom structural heart device components, including polyimide-coated wire, high-spring constant coils, braided shafts, polyimide tubing, braided multi-lumen extrusions, PT electrodes and marker bands, welded electrode assemblies, coated stainless wire-welded pull cables, thermocouples, micro-machined components, 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 through our physician advisory board; preclinical product evaluation; validated test methods; and medical device registration, reporting, and vigilance.
Materials and Processes
With comprehensive manufacturing capabilities, we develop cardiovascular 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 cardiovascular component and cardiovascular device we manufacture.
We maintain ISO 13485 certification across our facilities, as well as quality