Infuse, a Medtronic developed bone growth stimulator, is also known as Amplify when used in higher doses. While Infuse received very limited approval from the FDA, Amplify was not approved due to potential cancer risks.
Now, it appears that startling new information relating to inappropriate Infuse usage has been discovered. At a national spinal surgeon convention, Dr. Eugene Carragee noted that undisclosed clinical trial data “showed a significantly higher number of cancers in the study group that received Amplify when compared to a control group that received a bone graft as part of a spinal fusion….”
In that same article, Dr. Carragee also noted that Infuse may have been used off-label at higher-than-approved levels, levels possibly higher even than intended for Amplify, resulting in potential cancer risks to recipients.
Medtronic has responded to these claims by forking out $2.5 million to allow Yale researchers to independently analyze the Infuse data. This study has not been released; however, its results will likely provide additional insight into the safety of Infuse.
Richard J. Arsenault, 2011
