Medtronic earns expanded approval for Freezor Xtra Catheter
The Food and Drug Administration on Thursday approved Medtronic's Freezor Xtra Cryoablation Catheter to treat patients withatrioventricular nodal re-entrant tachycardia, an abnormal heart rhythm.
The Freezor Xtra Catheter is a flexible, single-use device used to freeze cardiac tissue and block unnecessary electrical signals in the heart, according to a news release.
More than 319,000 people live with AVNRT and more than 49,000 people are diagnosed annually, according to the report.
"The expanded indication for this catheter will allow more patients to benefit from a safe and effective therapy that can prevent heart racing, and allow them to get back to their normal activities," said Peter Wells, MD, heart rhythm physician at Baylor Heart and Vascular Hospital in Dallas, and principal investigator of the clinical trial supporting this use of the device.
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