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ARTICLE | Clinical News

Independent reviews of Medtronic's InFuse published

June 19, 2013 12:47 AM UTC

Two groups of academic researchers published data on Tuesday in the Annals of Internal Medicine from a pair of independent reviews analyzing the safety and efficacy of InFuse Bone Graft from Medtronic Inc. (NYSE:MDT), which is used in spinal fusion surgery. Based on an analysis of individual-patient data from 13 randomized controlled trials sponsored by Medtronic and 31 cohort studies, researchers at Oregon Health & Sciences University concluded that InFuse "has no proven clinical advantage over [iliac crest] bone graft and may be associated with important harms." The Oregon researchers also found that InFuse was associated with an increased cancer risk at 24 months, but event rates were low and cancer was heterogeneous. The researchers concluded that early journal publications misrepresented the effectiveness and harms through selective reporting, duplicate publication and underreporting.

In a separate analysis, researchers at the University of York reported data from an analysis of individual-patient data from 11 randomized controlled trials sponsored by Medtronic and one other eligible trial and concluded that InFuse "increases fusion rates, reduces pain by a clinically insignificant amount, and increases early postsurgical pain" vs. iliac crest bone graft at 24 months. Furthermore, cancer was almost twice as common with InFuse compared to iliac crest bone graft, but the small number of events precluded a definite conclusion. Medtronic said it has funded a retrospective analysis of a national payer database to investigate the incidence of cancer in real-world use of InFuse; the analysis is slated to be presented next half. ...