Medtronic agrees to independent scrutiny of Infuse Bone Graft

Published date : 30 August 2011
Article date : 30 August 2011

Following scrutiny from a US senate committee, Medtronic announced this month that it would give data and $2.5m funding to Yale University to review the safety of their Infuse Bone Graft product. It had been alleged that Medtronic had failed to mention side effects of the product which is a recombinant bone morphogenetic protein 2 (rhBMP-2) used to stimulate bone growth after spinal surgery. The arrangement is intended to allow two fully independent assessements of the data and is unusual in that access to full patient data has been granted rather than the summaries which are normal practice. 

For the press release from Medtronic, look here.

For an overview from the BMJ, look here. 

 

 

 

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