A Medical Device Daily Staff Report
Sintea Plustek (Milan, Italy) says it has launched its Domino cervical fusion cage implant made of Zeniva polyetheretherketone (PEEK) resin from Solvay Specialty Polymers.
The fusion cage implant, available in Italy and throughout Europe, has earned the CE mark. Sintea Plustek selected Zeniva PEEK – part of Solvay's line of Solviva Biomaterials, because of its modulus of elasticity which is very close to that of bone, thus allowing better load transfer. The thermoplastic biomaterial also has radiolucent properties which permit X-ray procedures and meets the requirements of ASTM F2026-12 for surgical implant applications, according to Laura Dell'Orto, technical marketing manager for Sintea Plustek. The Domino cervical plate-cage system allows cervical interbody fusion and disc height restoration by an anterior fixation. The implant system consists of an intersomatic cage made of 16 mm diameter machined Zeniva PEEK rod which is integrated with an anterior fixation plate made of titanium alloy.
The implant is available in three sizes. The cage has a convex shape on its superior face to fit perfectly in the intervertebral space and it is centrally opened to allow bone graft insertion which promotes fusion. The primary stability of the system, guaranteed by the anterior plate, is enhanced by the presence of notches on the superior and inferior surfaces.
Zeniva PEEK offers numerous advantages over metals such as titanium for spinal implants, Sintea noted. The material offers many important benefits including biocompatibility, chemical inertness, and a modulus of elasticity that is close to that of bone. Based on biocompatibility testing, Zeniva PEEK demonstrates no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity. It also boasts high strength and stiffness. Sintea Plustek uses Zeniva PEEK rod stock and performs high-precision machining to produce a full range of sizes. Zeniva PEEK and other Solviva Biomaterials are manufactured in Alpharetta, Georgia.
Sintea Plustek plans to sell the cervical fusion cage system globally and has already submitted technical documentation to regulatory bodies in various countries outside of Europe.