FDA clears expanded use of NuVasive bone void filler

Based on positive results from a recent study, the FDA has granted 501(k) clearance for NuVasive’s (NUVA +1.9%) Attrax Putty as a bone graft substitute without autograft.

The biologic is used in promote bone formation (healing) in patients who have undergone instrumented thoracolumbar posterolateral lumbar fusion (spinal fusion surgery in the lower back area).

The study showed the non-inferiority of Attrax Putty compared to autograft in terms of fusion rate (55% vs. 52% on a side-to-side comparison basis).

Attrax Putty was previously cleared for use with autograft (a bone graft taken from the patient and transferred to the area of the spine being fused).

https://seekingalpha.com/news/3550182-fda-clears-expanded-use-of-nuvasive-bone-void-filler