Solviva® Biomaterials for Implantable Medical Devices

With over 30 years of experience supplying high performance polymers to the healthcare industry, Solvay has become a leading provider of biomaterials for implantable medical devices. Solvay formulates Solviva® Biomaterials, a family of specialty polymers, to meet the industry demand for metal alternatives that provide optimal performance and meet the requirements for prolonged or permanent exposure to bodily fluids and tissue in the human body. This exceptional portfolio provides safe and reliable materials for a number of implant fields including orthopedics, cardiovascular, spine, sports medicine, extremities, trauma and more. It includes:

Eviva® PSU (polysulfone) is a transparent polymer that offers toughness and strong biocompatibility. This sulfone polymer maintains its dimensional tolerance right out of the mold and requires no machining. It is a rigid thermoplastic that doesn’t absorb fluids and is artifact-free for effective MRI imaging. It is also available in opaque white.

Veriva® PPSU (polyphenylsulfone) provides unsurpassed toughness combined with transparency and excellent biocompatibility.

Zeniva® PEEK (polyetheretherketone) is one of the most biostable plastics available with high strength and stiffness plus excellent toughness and fatigue resistance. Zeniva® PEEK meets the requirements of ASTM F2026-07 as a polyetheretherketone (PEEK) polymer for surgical implant applications. PEEK boasts a modulus of elasticity that is similar to that of cortical bone, minimizing reduction in bone density by maintaining normal stress on surrounding bone tissue. It offers excellent biocompatibility and fatigue resistance. Zeniva® PEEK also eliminates the risk of allergic reactions to heavy metals, and its radiolucent properties will not interfere with X-ray and computed tomography scanning procedures.
 

Comparison of stiffness-to-weight ratios 
Tensile modulus/density 

Zeniva-PEEK-comparison-stiffness-to-weight-ratios-01

 

All Solviva® Biomaterials can be sterilized using conventional methods, such as gamma radiation, ethylene oxide and steam. They demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity, based on biocompatibility testing as defined by ISO 10993:1. These sterilizable products are available in grades for injection molding or extrusion, as well as stock shapes for machined components.

 

Solviva® Biomaterials sterilization compatibility and material availability

Solvay-biomaterials-sterilization-and-material-availability

 

Solvay's specialty polymers for implantable devices* meet and exceed the highest industry standards of safety and quality excellence that OEMs require from their partners. The entire line of Solviva® Biomaterials is manufactured in our ISO 13485 and cGMP compliant dedicated facility in Georgia, USA. Materials are tested in our ISO 17025 labs and offer: Hundreds of regulatory approvals in USA, Europe, China and other regions • Available in pellets, rod stock and plate • Filled, high flow and low flow grades • Product traceability and change notification • Direct shipping and billing to processors • Validated process.


*Only products designated as part of the Solviva® family of biomaterials may be considered as candidates for medical applications implanted in the human body and devices that are in contact with bodily fluids or tissues for greater than 24 hours.


Outstanding Structural Properties

As part of the Solviva® portfolio of specialty thermoplastics for implantable devices, these materials meet the highest standards for strength and durability. For instance, Zeniva® PEEK, used in a wide range of cages and spacers for anterior and posterior fusions, offers outstanding strength and extreme toughness. The load-bearing reliability of this medical grade PEEK makes it an excellent material for structural fixations and long-term attachment devices as it outperforms metal with its stiffness-to-weight ratios. Additionally, Veriva® PPSU (polyphenylsulfone) provides superb toughness and strength in applications such as valves and shunts which treat hydrocephalus. 
 

Dimensional Stability

The dimensional integrity of both Eviva® PSU (polysulfone) and Veriva® PPSU offer superior moldability and manipulation into tight and complex shapes for an array of cardiovascular, neurovascular and dental applications. The flexibility of Eviva® PSU requires no expensive machining, which gives OEMs the ability to manufacture more cost-effective components for vascular and injection access ports compared to other commercial materials. Additionally, Veriva® PPSU offers exceptional moldability and is easily manipulated for optimized production of wire and lead coatings. 
 

Impermeability and Chemical Resistance

Structural implantable devices can often come in contact with bodily tissue and fluids as well as a variety of medical substances. To endure the demanding conditions and chemical exposure that implantable medical devices face, Solvay specialty polymers for implantable devices are designed with impermeability and chemically resistant properties. Eviva® PSU is impermeable, which makes it ideal for injection access ports. Additionally, Veriva® PPSU offers outstanding chemical resistance, which is optimal for wire and lead coatings in valves and shunts that help to regulate flow rates of essential pressure-based fluid delivery.
 

Optimal Radiolucency and Transparency

Solvay’s high-performing polymers are equipped with advantageous radiolucency and transparency qualities. Zeniva® PEEK provides implantable devices with radiolucent components to provide exceptional visibility for X-rays, CT scans, MRIs and other imaging methods. The transparent qualities of Eviva® PSU and Veriva® PPSU also allow un-obstructed imaging, which surpasses the preceding capabilities of lower performing materials. 

Solviva® Biomaterials for Implantable Medical Devices


Zeniva® PEEK

Zeniva® PEEK (polyetheretherketone) is a high-performance specialty polymer with high strength and advanced stiffness that offers extreme toughness and reliability for use in structural, load-bearing implantable medical devices. This biostable plastic is a 30% carbon fiber-reinforced, radiolucent specialty polymer with excellent fatigue and creep resistance. The unique properties of Zeniva® PEEK allow implantable devices to withstand continuous strain and repeat loading. Zeniva® CF30 PEEK has twice the strength of unmodified PEEK and gives manufacturers the ability to make smaller implants and reduce intrusiveness. This high-performance, biocompatible polymer helps implants to minimize bone density reduction by continuing to simulate normal stress on surrounding bone tissue, unlike implantable metals. Additionally, the radiolucency of Zeniva® PEEK offers exceptional visualization of implants when using X-ray, CT scan, MRI and other imaging methods. Solvay manufactures Zeniva® PEEK in compliance with ISO 13485 regulations and current Good Manufacturing Practices (cGMP) and ensures that it meets ASTM F2026-07 requirements as a PEEK polymer for surgical implant applications. Zeniva® PEEK is compatible with a full range of sterilization methods including steam, ethylene oxide gas, vaporized hydrogen peroxide and high-energy gamma radiation. 

The strength, resilience and structural properties of Zeniva® PEEK support a multitude of implantable device applications. Zeniva® PEEK is commonly used in spinal implants such as spinal cages and spacers for anterior and posterior lumbar interbody fusions (ALIF and PLIF). This specialty polymer also supports fixations in anterior and posterior cervical interbody fusions (ACIF and PCIF) and disc height restoration. In sports medicine, this high-performance plastic is an excellent material for fixations such as Suture Anchors and bone screws, which offer long-term attachment of ligaments and tendons to bones. Prospective applications of Zeniva® PEEK include dental implants, trauma implants and large joint implants in knee and hip surgery. 

 

Eviva® PSU

Eviva® PSU (polysulfone) is a transparent specialty polymer with excellent strength, weldability and stability and is widely used in the healthcare industry for implantable devices. The amorphous qualities of Eviva® PSU offer high moldability and advanced dimensional tolerance while maintaining a practical toughness that allows this rigid thermoplastic to remain impermeable. Its moldability and excellent strength set it apart from other less efficient commercial materials. Eviva® PSU does not absorb or interact with targeted drugs and remains artifact-free, which enables effective MRI imaging. This high-performance specialty polymer is lightweight and requires no expensive machining, which makes Eviva® PSU a more cost-effective implant material than previous all-titanium versions. Solvay manufactures Eviva® PSU in a dedicated ISO 13485 and cGMP compliant facility, and its proven biological safety ensures maximum sterilization compatibility with steam, ethylene oxide gas, vaporized hydrogen peroxide and high-energy gamma radiation. Like all Solvay specialty polymers, Eviva® PSU is tested in ISO 9001-certified and ISO 17025-accredited laboratories.

Eviva® PSU is available in transparent or opaque white for a broad range of applications. Primarily used in access port implantation devices, this high-performance polymer has an extensive history of use in cardiovascular, neurovascular, drug delivery and dental applications. The flexible, lightweight and transparent properties of Eviva® PSU provide OEMs with the ability to manufacture low-profile components for optimized, low-risk vascular or injection access.

 

Veriva® PPSU

Veriva® PPSU (polyphenylsulfone) is a high-performance specialty polymer that offers medical implantable devices outstanding toughness and impact resistance. Veriva® PPSU is amorphous, biocompatible and outperforms other polyphenylsulfone materials in durability tests. The advanced chemical resistance, enhanced insulation and unsurpassed toughness of Veriva® PPSU give medical applications the ability to withstand a full range of sterilization techniques including high-temperature steam, ethylene oxide gas, multiple-cycle hydrogen peroxide and high-energy gamma radiation. Like all Solvay specialty polymers, Veriva® PPSU is produced in ISO 13485 and cGMP-compliant labs.

The superb biocompatibility and reliable insulation capabilities of Veriva® PPSU make it the ideal candidate for wire and lead coatings. As polymer resin coatings emerge as the industry standard, the amorphous, chemical-resistant properties of Veriva® PPSU surpass all rivaling commercial materials. Its strength and durability allow devices to endure any applicable levels of pressure, which makes Veriva® PPSU optimal for valves and shunts. Accordingly, this high-performance polymer is an essential material for implantable devices used to treat hydrocephalus.