FDAnews
www.fdanews.com/articles/67892-advanced-biomaterial-receives-fda-clearance-to-market-symphony

Advanced Biomaterial Receives FDA Clearance to Market Symphony

January 24, 2005

Advanced Biomaterial Systems has received 510(k) clearance from the FDA to market ABS' Symphony VR Radiopaque Bone Cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

Symphony VR bone cement comes premixed with a radiopacifier and provides the spine physician with longer working time and lower exothermic temperature while using less monomer than other products currently on the market.

"This FDA clearance now allows ABS to market its Plexis mixing and delivery system together with ABS' Symphony VR radiopaque bone cement as a complete and controlled solution to spine physicians for stabilizing spinal compression fractures for use in either vertebroplasty or kyphoplasty procedures," said Pete Carr, ABS' president and CEO.