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 report 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 to review those initial reports.
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.
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