The Oregon Evidence-based Practice Center at Oregon Health & Sciences University in Portland has been selected as one of two research centers that will independently review clinical studies on rhBMP-2, according to an OHSU news release.
The literature review will analyze Medtronic-sponsored studies on its FDA-approved recombinant bone morphogenic protein product Infuse. Infuse is used to promote fusion during spinal surgery and has recently been under scrutiny after surgeons experienced adverse events while using the product.
Earlier this year, Medtronic agreed to fund a literature review conducted by Yale School of Medicine in New Haven, Conn., to review the studies, which will include original data from the FDA trials. Yale has now asked Oregon EPC and the Centre for Reviews and Dissemination at the University of York in the United Kingdom to help with the review.
Rochelle Fu, PhD, a biostatistician at Oregon EPC, will be the lead investigator on the Oregon EPC analysis. When the reviews are complete, each center will issue a report to be made public in the summer of 2012. Medtronic has no direct role in these two reviews apart from supplying data and supporting materials.
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Earlier this year, Medtronic agreed to fund a literature review conducted by Yale School of Medicine in New Haven, Conn., to review the studies, which will include original data from the FDA trials. Yale has now asked Oregon EPC and the Centre for Reviews and Dissemination at the University of York in the United Kingdom to help with the review.
Rochelle Fu, PhD, a biostatistician at Oregon EPC, will be the lead investigator on the Oregon EPC analysis. When the reviews are complete, each center will issue a report to be made public in the summer of 2012. Medtronic has no direct role in these two reviews apart from supplying data and supporting materials.
Related Articles on Spine Devices:
Mazor Sells Three U.S. Robotic Spine Systems in 3Q, Reports $1.5M in Revenue
New FDA Product Codes Make Billing for RSB Spine's InterPlate System Easier
Medtronic Launches T2 Altitude Expandable Corpectomy Device