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Affecting adults and children, structural heart disease encompasses non-coronary defects in heart function principally involving the heart’s valves or chambers. Interventional methodologies in this area have grown rapidly in recent years. Improved imaging techniques as well as catheter-based approaches have fostered significant advances. At Zeus, our expertise and innovative technologies have made us a global leader in delivering the revolutionary polymer device components for these critical minimally invasive procedures.
Refined technologies have led to improved detection of abnormalities in the anatomical structures and function of the heart. Defects found are either congenital or due gradual deterioration from disease. High blood pressure, medications, aging, plaque in coronary arteries, rheumatic fever, and infection are but a few conditions that can result in structural heart disease. To address these disease states requires delicate procedures with premium catheter components and advanced biomaterials. Clinicians and engineers likewise require a partner that values precision as well as quality – that is where Zeus delivers.
While advances are currently in development for many valve replacements, the most prevalent thus far are transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve replacement (TMVR). These procedures are minimally invasive techniques to replace these critical heart valves and restore as near as possible normal heart function. This emerging catheter-based technology accesses the heart through either the femoral artery (transfemoral) or apex of the heart (transapical).
Zeus products play a leading role in lifesaving TAVR and TMVR procedures. Our products are also highly featured in other procedures including left atrial appendage closure (LAAC) and the closure of atrial septal defects (ASD) and ventricular septal defects (VSD). Delivery systems for these procedures use a range of Zeus extrusions including PTFE, Aeos™ ePTFE liners, FEP heat shrink, and pusher tubes made from nylon, PEEK, or polyethylene. As suture monofilament, our Aeos™ ePTFE can be used to repair or replace stretched, damage, or broken chordae tendineae to restore mitral valve function.
Available with extremely thin walls and tight tolerances, our products enable device R&D engineers to maximize the catheter’s lumen for the passage of devices or diagnostic and surgical tools. Implantable devices may be encapsulated with a cover or “skirt” made from Zeus Bioweb™ or Aeos™ ePTFE technologies that facilitates integration with the heart tissue.
Every day we build on our experience to meet your challenging clinical demands with core products modified for enhanced performance and manufacturability. For more information about our catheter and other device components, contact us or call today toll-free in the US 1-800-526-3842. Internationally, you can reach us at +1-803-268-9500.
Catheter Components – From ultra-thin liners to high impact polymer products with extreme pushability, Zeus extrusions are at the core of complex catheter design and assembly processes. We manufacture nearly all delivery device components necessary for complete catheter construction and customize the inside diameter (ID) size with the tolerances to precisely fit and secure your implant device. Zeus Drawn Fiber and LCP monofilament provide non-metal catheter reinforcement braiding to create MRI-compatible catheters.
Septal Defects – Defects in the walls, or septa, of the heart chambers eventually lead to holes that allow blood to flow between the chambers. Zeus technology underpins both the catheter delivery system and the implant itself for a corrective procedure to address these defects. The procedure involves the placement of discs in the septum wall supported by wire or polymer scaffolds. Zeus Aeos® ePTFE or Absorv® bioabsorbables are commonly used in the final implant of such devices.
Sutures – Zeus offers monofilament and drawn fiber products which can be tailored to varied wound closure types. Our Aeos® ePTFE suture monofilament, as an example, can be swaged onto needles up to a 1:1 ratio and is available in bulk to create your own suture lines. These high-tensile Aeos® ePTFE products are breathable and provide excellent scaffolding material for tissue growth and faster recoveries.
Synthetic Chordae Tendineae – Chordae tendineae are the tendinous cords that attach the mitral (bicuspid, left atrioventricular) and right atrioventricular (tricuspid) heart valve leaflets to the cardiac wall. When these “heart strings” become damaged, the valves do not function fully. Zeus’ high tensile Aeos® ePTFE monofilament replaces damaged chordae tendineae to restore functionality to these valves.
Catheter Braiding – When metals cannot be used in certain catherization procedures, Zeus offers drawn fibers available in PEEK polymer and LCP monofilament as non-metallic and flexible alternatives to stainless steel braiding. These materials are MRI-compatible and available in flat and rounded profiles.
Catheter Liners – Typically made of etched PTFE or our Aeos® ePTFE, these inner liners of catheters provide the utmost in lubricity, electrical performance, chemical resistance, and are UV sterilizable.
Customized Tubing – We offer a wide range of fluoropolymers and specialized plastics with a history of success in medical device applications. For your particular 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 add a protective and tight jacket covering for joined catheter components or simply as an outer covering for the catheter itself. We offer heat shrink in a range of polymer resins that can withstand high temperatures and contribute extremely high lubricity. FluoroPEELZ® peelable heat shrink simplifies catheter construction due to its ability to be easily peeled away from the outer catheter shaft after reflow. End users are finding that this cost-effective and safe replacement for FEP heat shrink reduces their downstream processing and accelerates production.
Jacketing Materials – Catheter jackets are developed to provide additional structural support when added as layers during catheter construction and wall build-up. Removable jackets (such as Zeus FluoroPEELZ® peelable heat shrink) are also available that can be used to reflow underlying polymer coating or jacketing material over the catheter braiding. We offer nylon and Pebax® polymer jacketing to meet these catheter manufacturing needs.
Multi-lumen Catheter Tubing – This tubing creates multiple passages through which several simultaneous treatments or instruments can be directed towards the treatment site. These extrusions are made with tight tolerances, unsurpassed capabilities, and superior quality standards. These specialized tubings are available in PFA, FEP, PTFE, expanded PTFE (Aeos® ePTFE), polyethylene (PE), PEEK, and nylon.
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 fluoropolymer catheter components are highly lubricious and are ideal for use as mandrels with easy removal; these are available in PEEK and PTFE.
Biomaterials – The emergence of biomaterials, substances or materials that can safely interact with the body, has become a driving force in medical innovation. Bioabsorbables are especially suitable for therapeutic applications to provide an alternative to traditional polymers and metal components. Recognizing this need, we have expanded our capabilities in multiple areas to develop the most advanced biomaterials in the industry.
Absorv™ Bioabsorbable Extrusions – These polymer products can safely be implanted in the body and remain for controlled lengths of time before being absorbed without adverse interactions. We partner with our customers to develop and deliver advanced polymers to meet their precise degradation rates and specifications. These FDA-approved products are available in multiple extrusion forms.
Aeos™ ePTFE – These advanced products feature microscopic pores in the structure of the material by expanding PTFE under exacting conditions. The resulting porous products are imparted with unique physical properties that make them ideal for use in medical devices such as endovascular stent grafts, suture-like devices, structural heart, and tissue engineering. Aeos® ePTFE has many of the same exceptional attributes as PTFE but differs because it provides unique properties for applications requiring porosity.
Bioweb™ Electrospun Nonwovens – Our Bioweb™ is a technology produced through electrospinning PTFE into polymeric fibers with extremely small thicknesses ranging from the nano- to micro-scale. Together, these electrospun fibers form a microporous material with a broad range of properties. Similar to expanded PTFE, Bioweb™ has a lower basis weight than typical PTFE but has comparable chemical and temperature resistance. Bioweb™ is used in medical and industrial applications for biological interactions or for specialty filtration. Our process allows us to create encapsulation technology, spin membrane/sheet, and develop 3-D structures for coating substrates of varying shapes and sizes.
FEP – Fluorinated ethylene propylene, also known as FEP, is a melt-processable fluoropolymer that allows for long, continuous lengths and has several distinct advantages over PTFE. FEP tubing is usually chosen for applications that require more optical clarity and flexibility. In heat shrinkable form, FEP has a lower recovery temperature than PTFE and can be used to reflow softer underlying materials such as Pebax® during catheter construction. This chemically inert material has low gas permeability and possesses an excellent UV transmission rating and dielectric strength. FEP is gamma, ETO, e‑beam, and autoclave sterilizable and can operate in sustained temperatures from -328 °F (-200 °C) to 399 °F (204°C).
FluoroPEELZ® – This peelable heat shrink is ideal for fusing sleeves for catheter construction. Removing FluoroPEELZ® during this last production step is faster, easier, and safer than standard FEP heat shrink removal.
LCP – Liquid crystal polymer, or LCP, is a thermoplastic resin which exhibits unique properties. This material has a host of desirable traits including exceptional mechanical strength, heat tolerance for autoclaving, and chemical inertness. Through Zeus’ innovative 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.
Nylon – Aside from Pebax®, Zeus extrudes nylon tubing (including multi-lumen) and can assist in the selection of the specific grade of nylon best suited for your catheter jacketing application. Our engineered nylon is available in a wide range of grades suited for many custom applications including our Sub-Lite-Wall®, Zytel® (Nylon 6/6; Zytel 42A and ST801), Rilsan® (Nylon 11; Rilsan® B), Grilamid® (Nylon 12; Grilamid® L25, Rilsan® A, Vestamid® L2140, Grilamid® TR55 and TR55LX), Vestamid®, and others.
PE – Polyethylene, or PE, is available in multiple extruded forms, special profiles, and in a variety of hardness based upon your specific needs. PE has been used for such diverse applications as artificial tendons to catheter tubing and is available as high-density PE (HDPE – the hardest and stiffest form of PE), low-density PE (LDPE – the softest and most flexible PE), medium-density PE (MDPE), and linear low-density PE (LLDPE). Depending on the specific PE used, this polymer can operate for extended durations at up to 130 °F (54 °C).
Pebax® – This material (also known as PEBA, or polyether block amide) is used as a jacketing material for catheters to provide structural support and strength without sacrificing flexibility. Pebax® is a versatile polymer with high elastic memory. Pebax’s® properties can easily be altered by varying its monomeric ratios and block types thus imparting a wide range of mechanical properties such as flexibility to the final tubing. This material is available in Shore D hardness ranges from 35 to 72.
PEEK – Polyether ether ketone, or PEEK, is a high performance fluoropolymer 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 can be sourced with IDs as small as 0.002″ (0.051 mm) with walls as thin as 0.0015″ (0.0381 mm) and can also be used for support mandrels. PEEK Drawn Fiber is an excellent alternative for braiding over catheters where metal may be undesirable (such as for MRI, etc.). PEEK can likewise be used as an alternative to things besides metal such as glass. PEEK tubing is lightweight and able to withstand operating temperatures of 500 ºF (260 ºC). PEEK is biocompatible, 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 a highly lubricious material and is preferred in many applications in the medical field. With the lowest coefficient of friction of any polymer, this material is biocompatible (USP Class VI approved) and easily tolerates ETO and autoclave sterilizations. PTFE may be supplied etched on the outer diameter (OD) to allow better bondability with other materials. PTFE’s temperature range is -328 °F (-200 °C) to 500 °F (260 °C) and can be extruded in precision tolerances. This diverse polymer is available in a variety of forms including special profiles, monofilament, and multi-lumen for passing of wire guides, irrigation, steering cables, and more. Because of its lubricity, PTFE is also a good option for a support mandrel for catheter construction.
PTFE Sub-Lite-Wall® – This specialized PTFE is used for the lining of catheter IDs and allows easier access to difficult-to-reach body spaces; it also can be etched. PTFE Sub-Lite-Wall® Heat Shrink improves the lubricity of wire guides over long lengths for use in endoscopy applications.