Solviva® Biomaterials for Implantable Medical Devices
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 (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 (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.