Infuse is an implantable device that uses a biological agent to stimulate bone growth to treat degenerative disc disease of the spine.
Infuse has been implanted in more than 1 million patients, but approximately 85 percent of the time it was used off-label, according to a Milwaukee Journal Sentinel report.
Nashville-based Vanderbilt University orthopedic surgeon Dan Spengler, MD, said in the report many of the patients likely experienced excess bone growth following an off-label surgery.
Medtronic spokeswoman Cindy Resman said in the report Medtronic will “vigorously defend [Infuse] in court.”
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