The Yale led reanalysis of the BMP-2 InFuse trials
Interviewed by Steven E. Greer, MD
Medtronic granted rare access to a team led my Yale’s Harlan Krumholz and turned over the complete datasets on 17 InFuse (BMP-2) clinical trials. The goal was to determine whether adverse events being reported in real world usage were significant trends requiring new label warnings. Yale contracted Oregon Health and Sciences University to conduct one of the meta-analysis. We interviewed the lead author, Rongwei Fu, PhD.
Dr. Fu explains her findings. BMP-2 showed no efficacy advantage over other methods to fusing the spine, while also showing increased adverse event rates. In the cervical spine, their group concluded that BMP-2 was contraindicated.
FDA, Internal medicine, Late Breaking Data, Medical Devices, Neurosurgery, Oncology, Oregon H&S Univ, Spine surgery, Yale | apples49 | 
August 6, 2013 7:27 am
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