With comprehensive manufacturing capabilities, we develop cardiovascular catheters and cardiovascular 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 cardiovascular component and cardiovascular 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.
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, lamination, multi-durometer polymers, Radiopaque-loaded polymers, reflowed shafts, pressure extrusion, thin-walled tight tolerance and lubricous liners
Support Members / Marker Bands
Coils, marker bands, laser/machined-metal spines and ground cores
Machined Components
CNC machining, laser cutting, laser hole drilling, EDM and precious metals (platinum, gold, & other alloys)
Assembly
Hub molding, 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.