With comprehensive manufacturing capabilities, we develop cardiovascular 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 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.
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, lamination, multi-durometer polymers, radiopaque-loaded polymers, reflowed shafts, pressure extrusion, thin-walled tight tolerance and lubricous liners
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
Pull Cables
Resistance laser welding, soldering and sub-assemblies
Support Members
Coils, 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
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 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.
Steerable Sheath with Dilator
- Proprietary single pull-wire steerable platform
- Articulating sheath tip
- Handle with integrated locking mechanism
- 67 cm working length
- Regulatory-approved steerable sheath in 8F and 9F sizes
- 8 Fr sizes (ID: 2.7mm, OD: 3.8 mm)
- 3.94 cm active tip reach at 90 degree deflection
- 3.15 cm curve at 180 degree deflection
- 9 Fr sizes (ID: 3.1 mm, OD: 4.2 mm)
- 4.5 cm active tip reach at 90 degree deflection
- 4.2 cm curve diameter at 180 degree deflection