Thermoplastic Biomaterial Delivers Toughness and Transparency
LYON, France – Implantable brain shunt valves and access ports from France-based Sophysa, a leading supplier of adjustable neurosurgical valves for hydrocephalus treatment, are made of Eviva® polysulfone (PSU) resin from Solvay Specialty Polymers. Eviva® PSU is part of Solvay’s Solviva® Biomaterials line offered for use in implantable medical devices. Solvay made the announcement at the Eurospine 2014 conference Oct. 1-3 in Lyon, France.
Sophysa offers a complete range of implantable brain shunts for the treatment of hydrocephalus. Adjustable and mono-pressure valves made of Eviva® PSU are designed to control the drainage of the cerebrospinal fluid (CSF) from the brain ventricles. The transparent body made of Eviva® PSU provides direct visualization of the pressure level before implantation.
Sophysa also offers the Soph-A-Port® range of implantable access ports for chemotherapy and morphine therapy, that have been specially designed for safety and patient comfort. These ports are made of Eviva® PSU and can be used for arterial, venous, peritoneal, and spinal accesses. Both the brain shunts and access ports are injection molded by Sophysa in their ISO 13485 certified facility in Besançon, France.
For both implantable applications, Sophysa chose Eviva® PSU for its tensile strength, transparency, and regulatory compliance. Both the brain shunts and access ports have earned the CE (Conformité Européenne) mark which demonstrates compliance with numerous EC directives, and enables the product to be sold throughout the European community.
Eviva® PSU is a transparent resin that offers toughness and strong biocompatibility. The material 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.
Sophysa sells its implantable devices worldwide and has already submitted technical documentation to regulatory bodies in various countries outside of Europe.
The manufacturing site for Eviva® PSU and other Solviva® Biomaterials in Alpharetta, Ga., is ISO 13485 registered and the relevant aspects of current Good Manufacturing Practices are also applied. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an ISO 17025 accredited lab.
In addition to Eviva® PSU, the Solviva® Biomaterials line includes Zeniva® polyetheretherketone (PEEK), which boasts a modulus very close to that of bone, plus excellent toughness, biocompatibility, and fatigue resistance; Veriva® polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility; and Proniva® self-reinforced polyphenylene (SRP), one of the world’s stiffest and strongest unreinforced thermoplastic, which offers exceptional biocompatibility and hardness.
Founded in 1976, France-based Sophysa was the pioneer in the development of adjustable neurosurgical valves to treat hydrocephalus. Introduced in 1984, the Sophy® valve was the first adjustable valve in the world allowing non-invasive adjustment of operating pressures to match an individual patient’s changing clinical needs. Sophysa's core competency is the management of cerebrospinal fluid, allowing the company to offer a platform of products for two major medical specialties, neurosurgery and neurotrauma. In France and Benelux, Sophysa products are marketed by direct sales representatives. In the rest of the world, Sophysa markets its products through an international network of exclusive distributors. For more information, visit www.sophysa.com.
About Solvay Specialty Polymers
Solvay Specialty Polymers (www.solvayspecialtypolymers.com) is a leading global supplier of high-performance thermoplastics for permanent and prolonged exposure implants and limited exposure devices. The company has expanded its focus on the healthcare industry to meet the growing needs of its global customers by providing global technical and regulatory support. Solvay is building on its 25-year history as a key material supplier in the healthcare field, devoting considerable new resources to help customers be more efficient and cut costs. Metal-to-plastic replacement remains a key focus for manufacturers, but increased cost pressures pose a new challenge as the market continues to grow at a double-digit pace. Solvay also continues to devote considerable research and development activities to polymer technology and commercialization of new and unique material options for medical OEMs and processors.
Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra polymers, high-barrier polymers and cross-linked high-performance compounds – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil Gas, Packaging, Plumbing, Semiconductors, Wire Cable, and other industries. Learn more at www.solvay.com.
Solvay (www.solvay.com) is an international chemical Group committed to sustainable development with a clear focus on innovation and operational excellence. It is realizing over 90% of its sales in markets where it is among the top 3 global leaders. Solvay offers a broad range of products that contribute to improving quality of life and the performance of its customers in markets such as consumer goods, construction, automotive, energy, water and environment, and electronics. The Group is headquartered in Brussels and its companies, which employ about 29,400 people in 56 countries, generated EUR 9.9 billion in net sales in 2013 (pro forma). Solvay SA is listed as SOLB on NYSE Euronext (www.euronext.com) in Brussels and Paris. Bloomberg (www.bloomberg.com) = SOLB:BB and Reuters (www.reuters.com = SOLB.BR.
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