Structural Heart Guidewires

We provide a full range of solutions to support every phase of the product life cycle for finished structural heart guidewires for transseptal access, TAVR, TMVR, LAA and transapical applications.

Design and development of finished structural heart guidewires.

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 custom and standard guidewires and components, including cores, mandrels, stylets, and coils.

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.

Materials
Coatings
Processes
Sensing/Transmitting
Market-Ready Product Offerings

Structural heart guidewires are available in a wide range of models and configurations. Our materials experts work with customers to achieve optimal product performance. The highest-quality materials are matched to the precise design specifications and requirements of every component and medical device we manufacture.

Cores

Materials: Stainless steel, nitinol, bi-metal and proprietary alloys

Proprietary Platform Technologies: MyriadCore™ Bi-Metal Core Technology, Twister® Core Technology, Twister® Prime Core Technology, AmplifyCore™ Advanced Alloy Core Technology

Coils

Materials: Stainless steel, platinum (all alloys), palladium, tungsten and bi-metal

Proprietary Platform Technologies: MyriadCoil™ Seamless Joining Technology

Proprietary coating processes and advanced coating expertise enable us to apply lubricious and dielectric coatings to a range of substrates to achieve optimal performance of the guidewires we manufacture.

Lubricious

Capabilities: Hydrophilic and hydrophobic (PTFE reel-to-reel, PTFE discrete length and silicone)

Proprietary Coatings: Aquarius® Hydrophilic Coating, Aquarius® Elite Hydrophilic Coating, Lubrigreen™ PTFE Coating, Excellence™ Silicone Coating

Dielectric

PTFE (PFOA-free), ETFE, polyimide and parylene

Hemocompatible

Heparin

With comprehensive structural heart guidewire and structural heart stylet development capabilities, our manufacturing sites undergo rigorous quality inspections and audits. 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.

	Wire & Tube Processing Core grinding, coil winding, torque cables and cut tubing
	Wire Coating PTFE (Spray coat, reel-to-reel and discrete length), hydrophilic and silicone
	Joining Laser welding, soldering, brazing, plasma welding and dissimilar metal joining
	Tip Shaping Tapered or non-tapered, spring coil, polymer jacket and J, micro-J, modified J
	Depth-indicator Markings Chemically etched, laser ablation and PTFE marker

We maintain strong R&D investment to develop new technologies that complement customer initiatives to incorporate electrical and optical capabilities into guidewires. Throughout our partnership, we provide the material testing, process design, inspection, traceability, and documentation required to meet complex and sophisticated requirements.

Sensing/Transmitting - Spiral Grooves - Integer

Mechanical

Delivery platforms: Spiral cut, cut tubing, spline wire and torque cables
Joining / attachment: Laser welding and wire wrapping
Coatings / coverings: Hydrophilic, dielectric and polymer jacket

Electrical/Optical

Wire harnesses: Twisted pairs, flex circuits and ribbon
Sensor/connector attachment: Electrical connector soldering, optical fiber connectors, optical fiber polishing, wire bonding

Guidewire Testing - Design Assurance - Integer

Design Assurance/Clinical

Industry & competitive benchmark testing, analytics/research and clinical

Predicate® Uncoated Guidewire for Vascular Access

Full-length spring coil wire design that provides exceptional wire-to-wire consistency and product performance for various percutaneous vessel access applications
Stainless Steel: 0.014″ – 0.095″ diameter
Nitinol: 0.018″ – 0.038″ diameter
Stainless Steel: 20 cm – 500 cm length
Nitinol: 30 cm – 500 cm length
Stainless steel or nitinol core and stainless steel coil

Paragon® Coated Guidewire for Vascular Access

Pre-coated PTFE guidewire that features a uniform coating process that eliminates inconsistencies associated with spray-coat technology
0.014″ – 0.095″ diameter
20 cm – 500 cm length
Stainless steel core and stainless steel coil

M-Wire™ Mandrel Guidewire for Vascular Access

Mandrel wire design that delivers the advantages of a smaller guidewire diameter while providing maximum body support
0.014″ – 0.35″ diameter
40 cm – 300 cm length
Stainless steel or nitinol core and tungsten, platinum, palladium, or stainless steel coil
Typical applications: Peripherally Inserted Central Catheter (PICC) insertion, micro access (including transradial) and sheath introduction for vascular access (arterial and venous)

Anchorwire™ Guidewire

Transseptal placement guidewire, with unique spiral tip design, that is designed specifically for transseptal puncture
0.025″ diameter
Available in 175 cm, 203 cm and 230 cm lengths
Stainless steel core & coil material

Structural Heart Guidewires

Cores

Coils

Lubricious

Dielectric

Hemocompatible

Wire & Tube Processing

Wire Coating

Joining

Tip Shaping

Depth-indicator Markings