The article headlined “Panel doesn’t relent in requiring RCTs for PFO/stroke indication” (Medical Device Daily, March 6, 2007) mistakenly identified AGA Medical (Plymouth, Minnesota) as one of the companies that had participated in the petition to FDA to waive the randomized control trial requirement. Franck Gougeon, president/CEO of AGA, one of the manufacturers of PFO closure devices, told MDD that his firm is committed to and is enrolling patients into a randomized, controlled clinical trial for its Amplatazer.

No Comments