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.
In an effort to salvage the reputation of Infuse, Medtronic has commissioned Yale reviewers to conduct an independent review of the data related to Infuse. The review’s conclusions are eagerly awaited by Medtronic CEO Omar Ishrak who hopes that Infuse will be vindicated once and for all therebysilencing those who have raised questions about the safety of this blockbuster spinal fusion product.
But one research analyst who does not cover Medtronic believes that Infuse’s fortunes won’t rise even if Yale reviewers grant it a clean bill of health.
“Given that we’ve already had the proverbial eyebrow raised about Infuse, will (doctors) go back to it, I don’t think so,” said Caroline Corner, an analyst with investment bank MLV & Co.
So, what will happen with the future of the market? The drop in the utilization rate of Infuse now leaves the door open for other companies trying to develop an alternative to Medtronic’s Infuse, Corner said.
According to a report from MedCityNews, while no product is currently available that could completely replace Infuse, there are a few that could come to be considered a next-best option.
These include Osteocel Plus sold by California firm NuVasive; Trinity Evolution, sold by Orthofix Biologics in Texas; and Vitoss sold by Pennsylvania firm Orthovita, now part of Stryker.
One product, called OsteoSponge, appears to be particularly promising, according to an analyst interviewed by MedCityNews. Made by Bacterin International, OsteoSponge performed well against Infuse in a small, head-to-head clinical trial. Not only did it perform as well as Infuse with none of the risks connected to the Medtronic product. And, OsteoSponge costs about 1/3 less than it’s competitor. Caroline Corner, the analyst from MLV & Co., told MedCityNews that if OsteoSponge can do as well in a larger clinical trial, it could gain some of Infuse’s market share.
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