Thornton Cleveleys (UK), January 17, 2017 – Early clinical results presented by surgeons at the 2016 annual meeting of the North American Spine Society (NASS)1 demonstrate high fusion rates at 6 months and beneficial clinical outcomes, for patients in the majority of cases, when PEEK-OPTIMA™ HA Enhanced is used for interbody-fusion devices. The implantable high-performance polymer, from Invibio Biomaterial Solutions, uniquely combines PEEK-OPTIMA, the principal PEEK-based biomaterial with over 15 years of proven history in clinical use, and hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, and is fully integrated.
Previous studies by Invibio have highlighted that enhancing bone apposition on all surfaces of an interbody-fusion device may offer better integration and improved potential for spinal fusion. “The findings on first clinical cases for PEEK-OPTIMA HA Enhanced presented at the NASS 2016 annual meeting are demonstrating the Invibio goal of providing solutions that have the potential to improve clinical outcomes and advance bone apposition in interbody-fusion procedures2,” said John Devine, Invibio Medical Business Director. “In addition, the results presented confirm that the partnerships we have forged with device manufacturers and surgeons are pioneering approaches that are leading to positive results for patients.”
The clinical results were evaluated for pain on the Visual Analogue Scale (VAS), opiate usage, neurological function, re-operations and complications. Fusion results were evaluated using anteroposterior (AP) and lateral X-rays at six weeks and 12 weeks, and a CT scan at six months. Dr Bassett concluded, “Very rapid visible bone fusion occurred in the interbody region in six weeks, according to plain radiographs, with correspondingly good clinical results including no neurologic consequences beyond 6 weeks, no implant migrations, no subsidence, and no pseudoarthroses. More importantly, 9/10 fusions were definitively solid on 6 month CT scan with autograft bone, despite some challenging patients. The one that didn’t show complete fusion was progressing to fusion and used one pack of tobacco daily, both pre- and post-operative, contributing to the fusion challenge.
Arm pain was resolved in all 8 patients; in 5/8 patients neck pain was resolved and improved in 7/8 patients. Furthermore, all 8 patients demonstrated improved neurological function, with residual numbness in 3/8, and residual weakness in 1/8 patients. 17/17 levels were fused 6 months post-operatively.
PEEK-OPTIMA HA 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. Developed by Invibio, a leading provider of biomaterial solutions, this innovative high performance polymer for spinal fusion implants eliminates the extra processing time and expense of alternative bone on-growth technologies, such as coatings. Implant devices made of the novel PEEK-OPTIMA HA Enhanced have already been cleared by regulatory bodies in both the US (FDA 510(k) clearance) and Europe (CE mark approval).