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Cervical vertebral body replacement system made from PEEK-Optima HA receives FDA 510(k) clearance

Image courtesy of Invibio Biomaterial Solutions

Omnia Medical (Morgantown, WV) has been granted the first FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-Optima HA Enhanced polymer from Invibio Biomaterial Solutions (Thornton Cleveleys, UK). The so-called Boxcar system is designed for use in cervical-corpectomy procedures, the replacement of a collapsed, damaged or unstable vertebral body located in the cervical spine.

Robert Gewirtz, a neurosurgeon based in Columbus, OH, collaborated on the development of the Boxcar VBR product. “I see many patients that require a cervical corpectomy, and it's exciting to have such an innovative option for these patients,” he said. “Boxcar is very easy to use and provides intra-operative flexibility, allowing me to dial in a VBR construct to match my patient’s anatomy. Hydroxyapatite is incorporated into the PEEK-Optima structure of the implant, which delivers potentially improved outcomes for my patients,” added Gewirtz.

The novel single-use device is available in two footprints and allows fine adjustments of height and lordosis (the inward curvature of the spine) using spacers and end plates. It features a hollow center and holes to accommodate autograft or allograft, while encouraging the formation of new bone, and includes anti-migration features, noted Invibio.

"There are a limited number of 510(k) FDA cleared cervical VBR products on the market, and for our company to gain the first approval for a PEEK-Optima HA Enhanced cervical corpectomy device is a great achievement,” said Steve Anderson, Vice President of Marketing at Omnia Medical. “I’m absolutely confident surgeons will see the clinical benefits for them and their patients. Omnia Medical is focused on bringing truly innovative products to market, and Boxcar is the first of many ‘first-to-market’ products from our company, going forward.”

Hydroxyapatite (HA), a well-known osteo-conductive material that enhances bone apposition, is fully integrated into the PEEK-Optima polymer matrix. Invibio´s enhanced biomaterial offers all the clinical advantages of PEEK-Optima Natural, including a modulus similar to that of cortical bone as well as reduced stress shielding and artifact-free imaging. It has been shown to improve bone apposition compared with unfilled PEEK-Optima Natural in pre-clinical studies. Early clinical results have shown solid fusions with dense bone apposition at six months and beneficial clinical outcomes for patients, revealing specific improvements in overall pain and neurological function when a PEEK-OPTIMA HA Enhanced interbody fusion device was used, according to Invibio.

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