Omnia Medical: First PEEK-OPTIMA™ HA Enhanced Vertebral Body Replacement System to Enter US Market

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US FDA 510(k) clearance paves the way for an innovative orthopaedic product that offers the potential to improve bone apposition and, as a consequence, patient outcomes

Thornton Cleveleys, UK (PRWEB) December 07, 2017

‘Omnia Medical VBR’ has been granted the first US FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA™ HA Enhanced polymer, from Invibio Biomaterial Solutions, for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. This advancement was the result of a three-way collaboration: orthopaedic implant company Omnia Medical partnered with JALEX Medical on product development and regulatory activities and with Invibio Biomaterial Solutions, who pioneered medical PEEK.

Robert Gewirtz, MD – Neurosurgeon, Columbus, Ohio, comments on the innovative orthopaedic product: “Omnia Medical VBR is an intuitive device that is easy for the surgeon to use, and the benefits of hydroxyapatite incorporated into the structure of the implant is a real advance for our patients as it potentially offers improved outcomes.I am happy that I was able to partner in this collaboration to help bring the …

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