FDA Grants Expanded Approval for Medtronic’s Catheter

Baylor Heart and Vascular Hospital supports research on new medical devices and treatments, most recently using a catheter developed by Medtronic. The Freezor Xtra Cryoablation catheter was approved by the Food and Drug Administration Thursday to treat patients with atrioventricular nodal re-entrant tachycardia, commonly known as abnormal heart rhythm.

“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,” Peter Wells, MD, a heart rhythm physician at Baylor, said in a statement.

The Freezor Xtra Catheter is a flexible, single-use device that freezes cardiac tissue and blocks unnecessary electrical signals in the heart. It aims to help the 319,000 people living with AVNRT, according to Medtronic, and the 49,000 people diagnosed with AVNRT annually.

Posted in Medical Devices, News.