Integer - Diagnostic Mapping Catheters
From Catheters
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.
Details
- 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.
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 for advanced, high-density diagnostic mapping
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.
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