FDA approval for implants made in radio visible material:Solvay Polymers

Solvay Specialty Polymers USA (Alpharetta, Georgia; www.solvayspecialtypolymers.com) has extended its range of “Zeniva” PEEK resins for use in implantable medical devices. The new radio visible PEEK-based material, “ZA-520” contains an image contrast additive providing contrasting capabilities for optimal visualisation with x-ray, CT and MRI imaging systems.
“Zeniva” PEEK is one of the four high-performance polymers in the company’s “Solviva” biomaterials family for use in implantable medical devices. The new compound is available in resin for injection moulding and rod stock, which can be high-precision machined for production of a full range of sizes and configurations.Spinal implant designer and manufacturer Eisertech(San Diego, California / USA; www.eisertech.com) has recently received clearance from the US Food and Drug Administration (FDA) for its new cervical cage and lumbar cage implants manufactured from “Zeniva” rods. The cage systems, made from various rod sizes, are hollow so that bone can grow through the device, fusing the adjacent bony surfaces of the vertebrae.
Eisertech’s business model is focused on lowering the cost of spinal implants. Eisertech president Lukas Eisermann said the company’s products can be adopted by surgeons without having to attend a specialty training course, and can be serviced and re-ordered by hospital or surgery centre staff through an online store without assistance from an on-site company representative. “This arrangement allows us to significantly streamline our business processes and infrastructure relative to traditional full-service implant manufacturing companies. That streamlining shows up as savings which we pass on to our customers,” he concluded.Solvay said it is currently in active product trials with several major medical device manufacturers using “Zeniva” PEEK and other “Solviva” biomaterials.