Orthovita, an orthobiologics and biosurgery company, has received the US Food and Drug Administration (FDA) 510(k) clearance to market Vitoss Bioactive Foam-2X bone graft substitute for use as a non-structural bone void filler for use in the spine, pelvis and extremities.
Orthovita said Vitoss Bioactive Foam-2X product has the same structure and porosity as compared to company’s current Vitoss Bioactive Foam bone graft substitute products, but contains increased levels of bioactive glass, which in-vitro testing has shown induces two times the deposition of calcium phosphate growth onto the surface of the implant, while retaining the same handling properties.
Vitoss Bioactive Foam-2X has the ability to soak and hold its own volume in bone marrow aspirate while retaining these biological fluids in pliable and compression-resistant forms, thereby providing all three key components for bone regeneration: scaffold, cells, and signals.
In addition, Vitoss Bioactive Foam-2X contains Orthovita’s Vitoss beta-tricalcium phosphate bone graft substitute scaffold and Kensey Nash Corporation’s proprietary collagen material.
Orthovita president and CEO Antony Koblish said their in-vitro data indicate the increased levels of bioactive glass double the overall bioactivity of the product.
"Other studies have shown that increasing the concentration of bioactive glass leads to faster and more abundant bone formation and believe that the combination of increased bioactivity and scaffold design will support more effective bone formation than before," Koblish said.
"We are pleased to offer physicians and their patients a new, enhanced product that combines increased bioactivity with our synthetic bone scaffold technology and this is the first in a series of anticipated product innovations Orthovita expects to introduce into the market over the next 18 months."