FDA advisers give OK for heart device

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.

The FDA isn't required to follow the advice of its outside advisers but does so most of the time.

The catheter device is threaded into the heart, where it uses nitrous oxide to freeze heart tissue in seconds or minutes. The freezing creates lesions that destroy, or ablate, areas in the upper chambers of the heart responsible for the abnormal rhythms.

The FDA previously has approved similar devices that rely on radio-frequency energy to create lesions. The Cryocor device would be the first to do so with cold, Riley said.

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