The recent controversy surrounding Medtronic Inc.’s Infuse bone graft is having some question what the future will hold for the company, and for the spinal fusion market.
First approved by the U.S. Food and Drug Administration (FDA) in 2002, Medtronic’s Infuse bone graft has been cleared for use in a type of spine surgery called anterior approach lumbar fusion, as well as two types of dental procedures. However, recent research has shown that Infuse, also known as recombinant human Bone Morphogenetic Protein-2 or BMP2, may increase the risk that patients will develop cancer and other serious side effects.
Concerns have also been raised about the Medtronic-funded clinical trials used to gain approval of Infuse, with some researchers charging that the studies downplayed serious complications associated with the bone growth protein.
Medtronic has also faced investigations launched by the U.S. Justice Department and the U.S. Senate Finance Committee over possible illegal promotion of Infuse for off-label uses, as well as a growing number of personal injury lawsuits filed by victims of alleged Infuse complications.
And, all of this controversy surrounding the medical device has caused the sales to continually and steadily decline, quarter after quarter, as doctors began limiting its use or abandoning it altogether.
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