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Medtronic submits full data on spinal protein to independent scrutiny

BMJ 2011; 343 doi: (Published 30 August 2011) Cite this as: BMJ 2011;343:d5484
  1. Deborah Cohen
  1. 1BMJ

The company at the centre of an investigation by a US Senate committee into an alleged failure to mention the side effects of a spinal treatment it makes has agreed to fund an independent review into the safety and effectiveness of the product. It is the first time that a medical technology company has agreed to this type of detailed scrutiny.

Medtronic announced in early August that it will give Yale University $2.5m (£1.5m; €1.7m) to review all published and unpublished data on the safety and effectiveness of Infuse Bone Graft, a recombinant bone morphogenetic protein 2 (rhBMP-2) that is used to stimulate bone growth in spine fusion surgery.

In what the company describes as “unprecedented in the medical industry,” academics will be granted access to full patient data possessed by Medtronic—and not …

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