14 October 2014
14 October 2014
Implantable brain shunt valves and access ports from France-based Sophysa 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 1st-3rd October in Lyon, France.
Solvay explains 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 states it 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.
Solvay claims 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.
The company states 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.
Solvay says the manufacturing site for Eviva PSU and other Solviva Biomaterials in Alpharetta, France, 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.