Solviva - Biomaterials for Implantable Devices
From Products from Solvay
Solviva is a family of biomaterials offered for use in implantable medical devices. 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.
Solviva Biomaterials meet or exceed the highest in...
Solviva Biomaterials meet or exceed the highest industry standards in terms of quality and biological safety. Products are available for prolonged exposure (greater than 24 hours to less than 30 days) and permanent exposure (greater than 30 days) to bodily fluids and tissue in the human body.
Solviva products can be sterilized using all conventional sterilization methods, including gamma radiation, ethylene oxide and steam.
More to Offer than PEEK
The Solviva family of biomaterials includes four distinct polymer chemistries, providing more options for meeting the needs of implantable devices used in orthopedics, cardiovascular, spine and more.
Zeniva polyetheretherketone (PEEK) 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.
Proniva self-reinforced polyphenylene (SRP) is among the world's stiffest and strongest unreinforced thermoplastic that offers exceptional biocompatibility and hardness.
Veriva polyphenylsulfone (PPSU) provides unsurpassed toughness combined with transparency and excellent biocompatibility.
Eviva polysulfone (PSU) offers practical toughness in a strong, transparent polymer. It is also available in opaque white.
Product Availability
Solviva Biomaterials are available directly from Solvay in both injection molding resins and stock shapes.
Quality
The entire line of Solviva Biomaterials is manufactured in compliance with ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.
Testing
Solviva Biomaterials, as medical device raw materials, are considered biocompatible based on the requirements of ISO 10993-1:2009 for long term implants. Detailed Master Access Files (MAF) are registered with the FDA to support our customer’s submissions for regulatory clearance.
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