FDA approves Altapore Shape Bioactive Bone Graft.-Baxter International

Baxter International Inc.announced FDA clearance of AltaporeShape Bioactive Bone Graft, the latest addition to the company’s next-generation bone graft substitute product line. Altapore Shape is designed to enhance bone growth and help achieve fusion, which can lead to reduced pain and other improved clinical outcomes for patients.

Altapore is a bioactive and osteoconductive silicate substituted calcium phosphate bone void filler. Altapore contains microgranules, sized 1–2 mm, with 80-85% macro porosity and 32-46% micro porosity, suspended in an absorbable aqueous gel carrier. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of Altapore is similar to human cancellous bone and is designed to promote enhanced bone growth..

With enhanced micro and macro porosity and ideal silicon content shown to be optimal for bone formation, Altapore is designed to promote early vascularization, increase cellular activity, and enhance bone growth as demonstrated in pre-clinical and in-vitro studies.