The Solviva Biomaterials line of high-performance plastics for implantable applications – manufactured by Solvay Specialty Polymers – is now commercially available in China, the company has announced. The biomaterials line, previously available in the US and Europe, is targeted to meet growing demand in the Chinese market, complementing Solvay’s other healthcare offerings in China that include medical polymers for non-implantable uses. The biomaterials will primarily be targeted at orthopedic and cardiovascular applications.
The expansion into the high-growth Chinese market is a key element of Solvay’s global strategy to grow the Solviva Biomaterials line, according to Judy Melville, global business manager for Solviva Biomaterials. “This is an important first step that will unlock key business opportunities and firmly position us for future growth,” said Melville. She noted that the expansion into China is the first of a series of planned expansions into new global regions. Solvay will serve the Chinese market from its Shanghai facility where it operates research and development, sales, and commercial activities.
For implantable medical devices, the Solviva Biomaterials line includes Zeniva PEEK, which boasts a modulus very close to that of bone plus excellent biocompatibility, toughness, and fatigue resistance; Proniva self-reinforced polyphenylene (SRP), one of the world’s stiffest and strongest unreinforced thermoplastic that offers exceptional hardness and biocompatibility; Eviva polysulfone (PSU), which offers practical toughness in a strong, transparent polymer; and Veriva polyphenylsulfone (PPSU), which provides toughness combined with transparency and biocompatibility.
Solviva Biomaterials can be sterilised via all conventional methods including gamma radiation, ethylene oxide, and steam. These products are available in resin for injection moulding or extrusion, as well as stock shapes for machined components.
The entire line of thermoplastics is manufactured in compliance with the relevant aspects of ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay’s biomaterial manufacturing processes are also validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.
Solvay’s commercial success in the US and Europe with materials is highlighted by the growing use of Zeniva PEEK in the spinal fusion market.
(PRA)