Registry data shows more than 10% of TAVR patients are being treated off-label

Edwards ($EW), Medtronic ($MDT) and other TAVR players are anxiously waiting for the FDA to expand the treatment's indication to include "intermediate-risk" patients. The devices are currently approved for high-risk patients who are too frail for open heart surgery. Interventional cardiologists are taking matters into their own hands. Registry data shows that more than 10% of TAVR recipients are being treated off-label, meaning they do not meet the FDA's recommended criteria for use. Dr. Ravi Hira, who analyzed the data, said the off-label patients' results "appear to be on par with the on-label indications." He added that "I think in general there might be some patients with a particular off-label indication who do much worse, and other patients with a particular off-label use who do much better, so teasing that out is what we're in the process of doing right now." More

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