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Structural Heart Steerable Introducer Sheaths & Transseptal Sheaths

We provide a full range of solutions to support every phase of the product life cycle of steerable introducer sheaths for 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.

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Materials and Processes
Sensing/Transmitting
Market-Ready Product Offerings

With comprehensive manufacturing capabilities, we develop structural heart introducer sheaths and transseptal 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 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.

Handles (Single & Bi-directional)

Custom design, off-the-shelf prototypes, ABS molding, Polycarbonate molding, Santoprene™ molding, metal components and MIM components

Molding

Master Unit Die (MUD) hub molding, single- or dual-cavity and insert molding

Extrusion

Low- & high-melt polymers, single-lumen, multi-lumen, bump tubing, co-extrusion, wire enforced, braided and liners

Wire Drawing & Dielectric Coating

Substrates: Clad wire, MP35N, stainless steel, platinum and polymer
Coatings: PTFE, ETFE, polyimide, polyethylene and nylon

Reinforcement Shafts

Computer modeling (Virtual Tube Modeling™) to maximize performance, braided, coiled, lamination, multi-durometer polymers, Radiopaque-loaded polymers, reflowed shafts, pressure extrusion, thin-walled tight tolerance and lubricous liners

Support Members

Coils, marker bands, laser/machined-metal spines, laser cut hypotubes and other capabilities

Pull Cables

Laser welded/steering mechanisms sub-assemblies

Machined Components

CNC machining, laser cutting, laser hole drilling, EDM and precious metals (platinum, gold, & other alloys)

Assembly

Laser welding, reflow, tipping and handle attachment

We maintain strong R&D investment to develop new technologies that complement customer initiatives to incorporate electrical and optical capabilities into catheters and sheaths. Throughout our partnership, we provide the mechanical design, process design, device testing, material testing, inspection, traceability, and documentation required to meet complex and sophisticated requirements. We support customers with the following catheter enabling platforms:

Mechanical competencies in delivery platforms, materials joining and precision coating to develop miniaturized sensor, electrical, and optical components.
Advanced electrical and optical design capabilities in fine wire joining, proximal ring connectors, sensor connector attachment, optical fiber connectors, optical fiber polishing, and wire bonding.
Clinical and design assurance to perform benchmark testing, technology research, and clinical evaluation.