NuVasive Inc.03.10.20
NuVasive Inc., a provider of spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the results of the study “Efficacy of a Standalone Microporous Ceramic vs. Autograft in Instrumented Posterolateral Spinal Fusion; a Multicenter, Randomized, Intra-patient Controlled, Non-inferiority Trial” published online in Spine. The results of this trial support the use of Attrax Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar posterolateral lumbar fusion (PLF). Supported by the results of this study, NuVasive received U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded use of Attrax Putty without autograft.
“A study of this quality immediately differentiates Attrax Putty from other biologics on the market,” said Matt Link, president of NuVasive. “Attrax has proven the critical role surface optimization plays in the effectiveness of bone grafting technology, and underscores the NuVasive approach to developing innovative solutions which deliver positive clinical outcomes for surgeons and their patients.”
The trial enrolled 100 patients across four hospital centers where they underwent an instrumented PLF procedure. Following randomization, Attrax Putty was applied to one side of the spine and iliac crest autograft and local bone was applied to the contralateral side, with each patient serving as their own control. Fusion was assessed by blinded observers at one year with CT scans showing fusion rates of 55 percent for the Attrax Putty side and 52 percent for the autograft side, with an overall fusion rate of 71 percent of levels. Attrax Putty alone successfully demonstrated non-inferior fusion performance compared to autograft in instrumented PLF.
“With increased focus on value-based medicine, surgeons and hospitals seek improved evidence when choosing a biologic for spinal fusion,” said Dr. Tyler Koski, associate professor of neurological surgery and orthopedic surgery at Northwestern Memorial Hospital in Chicago, IL. “Most data for bone graft materials is of lower quality and supports their use as bone graft extenders combined with autograft. The fact that Attrax Putty by itself demonstrates non-inferiority to autograft, the gold standard for bone grafts, speaks to the power of its unique surface technology, and with this study, I’m better informed in my clinical decision-making.”
Attrax Putty is a synthetic, bioactive and osteoconductive bone void filler for the repair of bone defects. This proprietary, advanced biomaterial features a surface microarchitecture which provides an instructive environment for bone formation without added cells or growth factors. The moldable graft material is resorbed and replaced by bone during the healing process.
“A study of this quality immediately differentiates Attrax Putty from other biologics on the market,” said Matt Link, president of NuVasive. “Attrax has proven the critical role surface optimization plays in the effectiveness of bone grafting technology, and underscores the NuVasive approach to developing innovative solutions which deliver positive clinical outcomes for surgeons and their patients.”
The trial enrolled 100 patients across four hospital centers where they underwent an instrumented PLF procedure. Following randomization, Attrax Putty was applied to one side of the spine and iliac crest autograft and local bone was applied to the contralateral side, with each patient serving as their own control. Fusion was assessed by blinded observers at one year with CT scans showing fusion rates of 55 percent for the Attrax Putty side and 52 percent for the autograft side, with an overall fusion rate of 71 percent of levels. Attrax Putty alone successfully demonstrated non-inferior fusion performance compared to autograft in instrumented PLF.
“With increased focus on value-based medicine, surgeons and hospitals seek improved evidence when choosing a biologic for spinal fusion,” said Dr. Tyler Koski, associate professor of neurological surgery and orthopedic surgery at Northwestern Memorial Hospital in Chicago, IL. “Most data for bone graft materials is of lower quality and supports their use as bone graft extenders combined with autograft. The fact that Attrax Putty by itself demonstrates non-inferiority to autograft, the gold standard for bone grafts, speaks to the power of its unique surface technology, and with this study, I’m better informed in my clinical decision-making.”
Attrax Putty is a synthetic, bioactive and osteoconductive bone void filler for the repair of bone defects. This proprietary, advanced biomaterial features a surface microarchitecture which provides an instructive environment for bone formation without added cells or growth factors. The moldable graft material is resorbed and replaced by bone during the healing process.