Cardiac Rhythm Management and Electrophysiology
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Disruptions in the heart’s electrical system can lead to serious consequences, including death. To treat these conditions, minimally invasive electrophysiology procedures have been developed to restore normal cardiac rhythm. At Zeus, we have been manufacturing precision catheter componentry serving the CRM/EP market for nearly 60 years.
Emerging therapies within electrophysiology, such as pulsed field ablation, require high-quality custom-manufactured components to meet the performance requirements of these novel procedures. Whether for lead delivery systems, catheter ablation, or mapping and access catheters, Zeus products can be found in some of the most advanced medical devices used to treat arrhythmias.
Industry-Leading Liners
Zeus’ ability to manufacture PTFE liners with extremely thin walls, combined with the material’s superior lubricity, makes it an ideal selection for the lining of lead delivery systems. Our PTFE Sub-Lite-Wall™ StreamLiner™ catheter liners offer among the thinnest walls and tightest tolerances in the industry. PTFE liners are chemically etched on the outside diameter (OD) to provide uniform adhesion to the outer catheter jacket. Zeus will tailor liners to your specifications to optimize tensile properties for your unique processing parameters while allowing maximum real estate in your working channel.
Simply PEEL It Off
Removing FEP heat shrink from the outer shaft after reflow is a tedious task for manufacturers. Zeus has developed FluoroPEELZ™, a peelable heat shrink that is easily removed to help improve efficiencies and operator safety during the catheter construction process. Large medical device manufacturers using FluoroPEELZ™ in their catheter designs have reported reduced downstream processing, increased yields, and minimal scrap – all of which provide cost savings.
Novel Materials and Treatments
Aeos™ ePTFE is an ideal material to coat left atrial appendage (LAA) occlusion devices for atrial fibrillation treatments. The porosity of this soft, flexible, biocompatible product promotes cellular in-growth.
Contact our team or call toll-free in the US 1-800-526-3842 or +1-803-268-9500 internationally for prototyping, samples, or to receive a consultation on the right solution for your design.
- APPLICATIONS
Ablation – Providing the correct balance of strength and flexibility for catheter jackets, our polymer-based catheter components have a proven track record of performance. Zeus offers a wide range of durometers and nylon grades of polymer jackets with excellent dielectric strength. Our products also possess broad temperature resistance and thus are able to handle RF, PF, and cryoablation procedures.
Diagnostic – When visualization is of primary importance, such as in angiography, our catheter components are chemically unreactive not only with the body but also with dyes commonly used for contrast material.
Lead Delivery – Zeus products support the critical demands of lead placement into target tissues. Our catheter componentry can be utilized to provide varying degrees of flexibility and strength for lead placement in the most challenging anatomical locations.
Mapping – For procedures where maximum flexibility is required, Zeus’ polymer linings and coatings provide optimum performance. Our drawn fiber and liquid crystal polymer (LCP) monofilament help increase catheter stability and torque while enabling the capture of detailed geometries and electrical maps.
Neurostimulation – Whether for direct stimulation of nerves or to relieve pain, these applications have been greatly improved through the use of catheters to place neurostimulation and modulator devices more accurately. Zeus catheter components are optimized for these device delivery applications. Extensive customization is also available, giving you more control over key parameters such as pushability, strength, kink resistance, torquability, and lubricity.
Pacemaker Insulation – Zeus heat shrinkable tubing provides insulation for implantable cardiac defibrillators (ICDs). These devices benefit from the lubricity, dielectric strength, chemical resistance, and temperature resistance of our heat shrink.
Pull Rings and Pull Wires – Deflectable catheters incorporate pull rings at the distal end attached to pull wires, allowing the catheter end to be precisely manipulated toward the diagnostic or treatment site. Zeus produces a range of products for wire guide coverings and sheathing for these applications.
- PRODUCTS
Catheter Liners – Typically made of PTFE that has been chemically etched to allow for bonding, these inner liners of catheters provide the utmost in lubricity, electrical performance, chemical resistance, and are sterilizable via multiple methods.
Customized Tubing – We offer a wide range of fluoropolymers and specialized plastics with a history of success in medical device applications. Depending on your needs, we can provide custom etching, flaring, tipping, and prototype sampling with quick turnaround and complete technical support.
Fusing Sleeves – Heat shrinkable fluoropolymer tubing provides an excellent way to reflow the underlying nylon or Pebax® jacketing material during catheter construction. We offer FEP heat shrink tubing and FluoroPEELZ™ peelable heat shrink as fusing sleeves, both of which can withstand high temperatures and contribute to a smooth surface finish for the completed device.
Jacketing – Catheter jackets are designed to provide additional structural support and flexibility through different durometers along the length of the catheter. Zeus offers a variety of nylon and Pebax® jacketing to meet these catheter construction needs.
Multi-lumen Tubing – This tubing creates multiple passages through which several simultaneous treatments or instruments can be directed toward the treatment site. Available in a variety of resins, these products are made with tight tolerances, unsurpassed capabilities, and superior quality standards.
Catheter Braiding – When metals cannot be used in certain catheterization procedures, Zeus offers drawn fibers and monofilaments available in PEEK and LCP as non-metallic and flexible alternatives to stainless steel braiding. These materials are MRI-compatible and available in flat and rounded profiles.
Processing / Support Mandrels – A building block for catheter construction, this polymer core provides the central arbor around which the catheter is made and supports the desired ID. After construction, the mandrel is removed to produce the final ID. Our catheter components are highly lubricious and are ideal for use as mandrels with easy removal; these are available in PEEK and PTFE.
- MATERIALS
Biomaterials – The emergence of biomaterials, substances or materials that can exist in the body, has become a driving force in medical innovation. Bioabsorbables are especially suitable for medical applications and provide an alternative to traditional polymers and metal components because they can be absorbed by the body. Recognizing this industry need, Zeus has expanded our capabilities in multiple areas to develop the most advanced biomaterials in the industry.
FEP – Fluorinated ethylene propylene, or FEP, is a melt-processable fluoropolymer that allows for long, continuous lengths and has several distinct advantages over PTFE. FEP is a preferred choice when optical clarity is vital while still maintaining flexibility. In heat shrinkable form, FEP has a lower recovery temperature than PTFE, and FEP can be used to reflow softer underlying materials such as Pebax® for catheter jackets. This chemically inert material has low gas permeability and possesses an excellent UV transmission rating and dielectric strength. FEP is also gamma, ETO, e-beam, and autoclave sterilizable.
LCP – Liquid crystal polymers, or LCPs, are thermoplastic resins that exhibit unique properties. These materials have a host of desirable traits, including exceptional mechanical strength, heat tolerance for autoclaving, and chemical inertness. Through Zeus’ proprietary processing, we have developed an LCP monofilament fiber for use as catheter braiding. This material possesses excellent tensile strength and surpasses many similar monofilaments, such as nylon, polyethylene naphthalate (PEN), and even polyether ether ketone (PEEK) in terms of stiffness. Most importantly, however, LCP monofilament used as catheter braiding results in a device that is fully compatible with magnetic resonance imaging (MRI) procedures.
Pebax® – This material (also known as PEBA, or polyether block amide) is often used as a jacketing material for catheters, providing structural support and strength while also allowing catheters to remain flexible. Pebax® is a versatile polymer whose properties can be easily altered by varying its monomeric ratios and block types, thus imparting a wide range of mechanical properties such as flexibility. This material possesses high elastic memory and is stronger than nylon 11. Pebax® is available in Shore D hardness ranges from 35 to 72.
PEEK – Polyether ether ketone (PEEK) is a high-performance polymer that has excellent heat endurance and one of the highest strength-to-weight ratios of any thermoplastic. PEEK products are used in a variety of medical applications due to their columnar stiffness and torsional strength in very thin walls. PEEK tubing can be sourced with ID’s as small as 0.002″ (0.051 mm) and nominal wall thicknesses as low as 0.0015″ (0.0381 mm). PEEK drawn fiber is an alternative option for braiding in catheters where metal may not be preferable. PEEK is lightweight and is able to withstand operating temperatures of 500 ºF (260 ºC). PEEK tolerates high burst pressures and possesses exceptional torsion stability. PEEK is also thermoformable and resistant to gamma radiation, wear, and impact.
PTFE – Polytetrafluoroethylene, or PTFE, is highly lubricious and is the preferred material in many applications in the medical field. This material has the lowest coefficient of friction of any polymer and easily tolerates ETO and autoclave sterilizations. PTFE has a working temperature up to 500 °F (260 °C) and can be produced with precision tolerances. This diverse polymer is available in a variety of forms, including tubing, special profiles, heat shrink, monofilaments, and multi-lumens.