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Ablation Catheters

We provide a full range of solutions to support every phase of the product life cycle of EP ablation catheters.

Design and development of complex ablation catheters including RF ablation catheters and alternative energy ablation catheters (cryo, laser and ultrasound).
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 ablation 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-machined ablation tips, 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 ablation 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.

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), 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, laminated, multi-durometer polymers, radiopaque-loaded polymers, reflowed shafts, pressure extrusion; and thin-walled tight tolerance and lubricous liners

Steerable Shafts

Multi lumen shafts with pull wire or alternative constructions for steerability

EP Spline and Basket Assembly

Complex spline assemblies

Electrode Rings

Marker bands, ring on wire assemblies, custom ring designs, pull cables, stainless steel, precious metals (platinum, palladium, gold), laser machining and laser cutting

Welded Electrode Assemblies & Pull Cables

Resistance laser welding, soldering and sub-assemblies

Support Members

Coils, laser/machined-metal spines and ground cores

Ablation Tips

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

Assembly

Electrode ring on wire, pull ring on wire, electrode swaging, EP diagnostic catheters, EP ablation catheters, fixed & steerable sheaths, distal electrode sub-assemblies and packaging & sterilization

Value-added Capabilities

Marker bands, ring-on-wire assemblies, custom ring designs, pull cables, tip forming, atraumatic tips, laser processing and laser welding

We maintain strong R&D investment to develop new technologies that complement customer initiatives to incorporate electrical and optical capabilities into catheters. 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 expertise to perform benchmark testing, technology research, and clinical evaluation.