After receiving the CE mark for its Domino cervical fusion cage implant, which is made from Solvay Specialty Polymers’ Zeniva PEEK resin, Sintea Plustek has launched the product in Europe.
According to Laura Dell’Orto, technical marketing manager for Sintea Plustek, the company selected Zeniva PEEK because of its modulus of elasticity that is very close to that of bone, thus allowing better load transfer. The thermoplastic biomaterial also has radiolucent properties that permit X-ray procedures and meets the requirements of ASTM F2026-12 for surgical implant applications.
A press release reported that 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 16mm diameters and machined Zeniva PEEK rod (which is integrated with an anterior fixation plate made of titanium alloy). The implant is available in three sizes, which allows for adaptation to the patient’s anatomy. 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.
The press release also noted that, based on biocompatibility testing, Zeniva PEEK demonstrates no evidence of cytotoxicity, sensitisation, 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.
