Transseptal introduction sheath

adultsteerable

We provide a full range of solutions to support every phase of the product life cycle for an EP steerable introducer sheath and transseptal sheath used in TMVR and LAA applications. Design and development of steerable introducer sheaths and transseptal sheaths. 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 catheters and sheaths 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. 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