ApaTech has presented new clinical data for its unique synthetic bone graft, Actifuse, suggesting that it can provide a preferable alternative to the current ‘gold standard’ therapy, Iliac Crest Bone Graft (ICBG), in the treatment of patients with degenerative lumbar spine disease. ApaTech is a world leader in applying the science of silicon to bone graft technology.
Two new studies presented today at the North American Spine Society (NASS) Spring Break Meeting have shown that Actifuse has the potential to be as clinically effective as ICBG, without the problems associated with the latter.
The first study involved 38 patients with a diagnosis of lumbar stenosis, followed up two years after treatment with Actifuse as part of a standard lumbar fusion procedure. Fusion rates were graded at two years in excess of 81 percent. Results also showed a 68 percent decrease in pain experienced pre-operatively, as measured by the Visual Analogue Scale (VAS) (8.0 pre-operatively to 2.6 at two years), with 95 percent of patients reporting satisfaction levels that were good or excellent. There were no incidences of infection, bone graft complications or instrumentation failures.
The authors concluded that that both clinical results and fusion rates were comparable to those routinely achieved with ICBG, without any adverse effects.
The second study involved 69 patients with degenerative lumbar spine disease, of which 45 percent had two levels fused, and 41 percent were fused at three or more levels. All patients underwent a standard posterolateral spinal fusion using Actifuse. 81 percent of patients had radiographic evidence of bilateral bridging bone one year after surgery. 57 percent of patients reported relief from back pain, and 67 percent reported relief of leg pain. The authors concluded that Actifuse is an excellent alternative to ICBG for posterolateral spinal fusion in patients requiring surgical treatment for degenerative disease of the lumbar spine.
“These data provide further evidence that Actifuse is an excellent alternative to ICBG for physicians and patients offering comparable efficacy to ICBG without the need to take bone from the patient’s own skeleton” commented Brad G. Prybis, MD, Carrollton Orthopaedic Clinic, Carrollton, Georgia.
“These results for Actifuse are very exciting. We are proud to provide a new option for physicians in the treatment of degenerative lumbar spine disease” said ApaTech CEO Simon Cartmell. “These data further demonstrate ApaTech’s leadership in the science of silicon and the biostimulative effects of Actifuse.”
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The unique silicate substituted calcium phosphate chemistry of Actifuse™ is a significant advance in synthetic bone graft technology and provides surgeons with a safe and effective alternative to both autograft and allograft. Actifuse™ accelerates the formation of bone and improves the subsequent organisation and strength of the graft/host bone composite structure. Unlike traditional calcium phosphate based or other silicon containing products, Actifuse™ is steadily and predictably remodelled by the host biology over time, ensuring that sufficient conductive scaffold remains for the duration of new bone growth and its subsequent maturation.
Actifuse™ is available as a range of granule and microgranule formulations, as an Advanced Bone matriX; Actifuse™ ABX, in a standard applicator as a formable graft material: Actifuse™ Shape and in an EasyPrep granule applicator.
ApaTech (apatech.com) specializes in producing synthetic bone repair material. It has operations in London, England, Foxborough, USA, and Berlin, Germany, and is a world leader in bone graft technologies, selling its products in 21 countries around the world.
The Company has developed a novel, silicate substituted calcium phosphate bone graft material, Actifuse, which underpins the Company’s leadership in applying the science of silicon to bone graft technologies. The Company believes that Actifuse™ is the first of a new class of synthetic bone graft materials that truly combine osteoconductive and biostimulative properties to accelerate bone formation and healing.
ApaTech is backed by international investors, 3i and Healthcor and was recognized as Britain’s fastest growing medical technology company in both the 2007 and 2008 Sunday Times Fast Track 100 fastest growing private companies review. ApaTech also won the 2009 Frost & Sullivan Award for Device Biologics Company of the Year recognizing the company’s position as a world leader in the orthobiologics market.