After Johnson & Johnson (J&J, New Brunswick, New Jersey) said that it was going to discontinue its work in the drug eluting stent (DES) market, my eyes then began to focus on Medtronic (Minneapolis), which has recently taken a beating in the wallet and court of public opinion with its bone growth product, Infuse.
I began asking myself how much longer before Medtronic finally abandons ship on this application.
I mean if there ever was a shining example of a device that has caused problems for a company then Infuse is it.
The med-tech juggernaut was dealt what one would call a disastrous blow when a published study from the Spine Journal linked its Infuse to a condition that can cause infertility in men. A subsequent article the journal published suggested that some researchers who were involved in previous studies of Infuse did not disclose many serious side effects.
To combat this, the company provided $2.5 million that will allow Yale University (New Haven, Connecticut) to conduct two independent reviews of the safety and effectiveness of Infuse, which has been on the market since 2002. Medtronic said it will provide Yale with all of the data from the clinical trials it sponsored, and all the side effect reports provided to the FDA.
On top of that, a much stronger version of Infuse, named Amplify wasn’t granted FDA approval due to concerns about possible cancer risks.
My colleague, Mark McCarty, Medical Device Daily, Washington Editor, summed up the situation perfectly in his August 5, blog entry on Medtronic and Infuse.
“So now Medtronic is faced with declining sales of its bone morphogenic products, a ton of negative press, and the possibility that FDA will force the firm to either file an IDE for these other indications or require something approximating a risk evaluation and mitigation program to tamp down off-label use. Either way, sales are going to suffer,” McCarty writes.
While declining sales almost seem like a given – will the decrease in revenue for these products be so much so that it would prompt Medtronic to cut its losses and move on?
It could just be a matter of time.