Press Release Summary:
PEEK-OPTIMA™ HA Vertebral Body Replacement System is used for thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. Unit is available in two footprints and helps to adjust height and lordosis using spacers and endplates. Suitable for surgeons, product can accommodate autograft or allograft. Replacement system comes with an osteoconductive material which enhances bone apposition.
Original Press Release:
Omnia Medical: First PEEK-OPTIMA™ HA Enhanced Vertebral Body Replacement System to Enter US Market
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
‘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 product to market.”
The novel single-use device is available in two footprints and allows fine adjustments of height and lordosis 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.
In PEEK-OPTIMA HA Enhanced, Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, is fully integrated into the polymer matrix, and not simply coated. Invibio´s enhanced 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. It has been shown to improve bone apposition compared to unfilled PEEK-OPTIMA Natural in a pre-clinical ovine model at 4 weeks and 12 weeks, and also demonstrated performance advantages in a pre-clinical cervical spine fusion model in sheep at 6 and 12 weeks. In addition, as observed by surgeons, early clinical results have shown solid fusions with dense bone apposition at 6 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.
Steve Anderson, Vice President of Marketing at Omnia Medical concludes: “We are happy to be the first to be granted FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced biomaterial. This unique material combination is a great option for the VBR application due to the large amount of natural anatomy removed during the procedure. Working with JALEX Medical and Invibio Biomaterial Solutions was an excellent experience – and will hopefully enable surgeons and patients to benefit from the new solutions.”