Three United States Senators have sent Medtronic a letter, asking for information about how it tracks medical devices after releasing them on the market, according to a Star Tribune report.
The letter continues to ask Medtronic information about its bone morphogenic protein product, Infuse. Infuse, which can help promote spinal fusions, has been under scrutiny since a study published in The Spine Journal highlighted unreported complications in the publicly released company-sponsored studies. The complications were not reported to the FDA, which proceeded to approve the device for limited applications in 2004.
A study is currently underway at Yale University in New Haven (Under a $2.5 million dollar grant from Medtronic) to review those reports. MDT is again trying to buy study results! You would think they would want objective results if they were not aware of significant problems.
The letter to Medtronic was one of five letters sent to medical device companies. A spokesman for Medtronic said the company was working on a response to comply with the letter's request.
Yes Infuse is taking a beating and MDT knew it was going to happen. That is why they purchased one of the largest allograft processors in the world with a deep product line for their reps to switch unhappy Infuse users over to.
Few others will see an increase in business simply because of less Infuse us. This will not rise to need of a hosptital switching vendors and away from MDT. Sorry.