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WASHINGTON (AP) - A medical device that relies on freezing cold to treat some abnormal heart rhythms should be approved, federal health advisers recommended Wednesday.
Cryocor Corp. still would have to meet several conditions before it could market its device, meant to correct an abnormally fast heart rhythm condition called atrial flutter, the Food and Drug Administration advisers said in an 8-2 vote.
Those conditions include training for doctors using the device, called the Cardiac Cryoablation System, as well as a registry of all patients undergoing treatment, agency spokeswoman Karen Riley said. The San Diego company also would have to conduct follow-up studies of the device that compare it to an alternative treatment, she added.
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