FDA has approved the first vertebral body replacement system manufactured from PEEK-Optima HA enhanced polymer. Orthopedic implant manufacturer Omnia Medical VBR (Morgantown, WV) received 510(k) clearance from FDA for the medical device, which it developed in collaboration with Jalex Medical (Westlake, OH), which contributed product development and regulatory assistance, and Invibio Biomaterial Solutions (Thornton Cleveleys, UK), which provided the material.
|The Omnia Medical vertebral body replacement system. Image courtesy
Vertebral body replacement is a type of surgery used to treat unstable fractures of the lower or middle regions of the spine, explains the Laser Spine Institute on its website. The highly invasive procedure involves replacing the damaged vertebra with one or more implants made of metal, ceramic, acrylic, carbon or, in this particular case, PEEK in order to improve alignment.
“Omnia Medical VBR is an intuitive device that is easy for the surgeon to use, and the benefits of hydroxyapatite (HA) incorporated into the structure of the implant is a real advance for our patients as it potentially offers improved outcomes,” said Robert Gewirtz, MD, a neurosurgeon in Columbus, OH, who is quoted in the press release distributed by Invibio.
The novel single-use device is available in two footprints and allows fine adjustments of height and lordosis—the normal inward curvature of the lumbar (lower) and cervical regions of the spine—using spacers and endplates. It features a hollow center and holes to accommodate autograft or allograft while encouraging formation of new bone and includes anti-migration features.
HA is an osteoconductive material that enhances bone apposition, and it is fully integrated into the PEEK-Optima HA matrix. The biomaterial offers all the clinical advantages of PEEK OPTIMA Natural, including a modulus similar to cortical bone, reduced stress shielding and artifact-free imaging that allows for clear fusion assessment, according to Invibio. It has been shown to improve bone apposition and demonstrate performance advantages compared with unfilled PEEK-Optima Natural in pre-clinical animal studies. In addition, as observed by surgeons, 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, said Invibio.