Structural Heart
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Affecting adults and children alike, 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 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 to 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. Addressing these disease states requires delicate procedures with premium catheter components and advanced biomaterials. Clinicians and engineers likewise require a partner who 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 close to normal heart function as possible. This emerging catheter-based technology accesses the heart through either the femoral artery (transfemoral) or the 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 products, including PTFE and Aeos™ ePTFE liners, FEP heat shrink, and pusher tubes made from nylon, PEEK, or polyethylene. Additionally, Aeos™ ePTFE high strength suture monofilament can be used to repair or replace stretched, damaged, or broken chordae tendineae to restore mitral valve function.
Every day, we build on our experience to meet your challenging clinical demands with core products modified to enhance 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.
- APPLICATIONS
Catheter Components – Zeus manufactures nearly all of the components necessary for catheter design and construction, from support mandrels, multi-lumens, liners, reinforcement, jacketing material, and fusing sleeves. Our components allow thin-walled, large-bore catheters to retain the preferred qualities such as torquability, distal end deflectability, pushability, and kink resistance.
Catheter Components – From ultra-thin liners to high-impact polymer products with extreme pushability, Zeus components 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 products that 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. Suture monofilaments are available in standard and high strength versions, are flexible, and provide excellent knot strength.
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 strength Aeos™ ePTFE suture monofilament can replace damaged chordae tendineae to restore functionality to these valves.
- PRODUCTS
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.
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 to enable better steerability or other functions. Available in a variety of resins, these products are made with tight tolerances, unsurpassed capabilities, and superior quality standards.
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
Bioabsorbable Materials – The emergence of these materials, 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.
Nylon – In addition to Pebax®, Zeus extrudes nylon tubing and can assist in the selection of the specific grade of nylon best suited for your jacketing or surface application. Our engineered nylon is available in a wide range of grades suited for many custom applications, including Nylon 6/6 (Zytel® 42A and ST801), Nylon 11 (Rilsan® B), Nylon 12 (Grilamid® L25, Rilsan® A, Vestamid® L2140, Grilamid® TR55 and TR55LX), and others.
PE – Polyethylene, or PE, is available in multiple extruded forms, special profiles, and in a variety of hardnesses 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).
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.