Expanded indication for cryoablation catheter approved by FDA

Medtronic announced that the FDA approved an expanded indication for its cryoablation catheter for use in patients with atrioventricular nodal re-entrant tachycardia.

According to a company press release, the catheter (Freezor Xtra) is a flexible, single-use device used to freeze cardiac tissue and block unnecessary electrical signals within the heart.

Atrioventricular nodal re-entrant tachycardia (AVNRT) affects approximately 319,000 people, and more than 49,000 people are diagnosed each year, according to the release.

"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, heart rhythm doctor at Baylor Heart and Vascular Hospital, Dallas, and principal investigator of the ICY-AVNRT clinical trial, said in the release.

Data from the ICY-AVNRT trial showed safety and efficacy for catheter in the treatment of patients with AVNRT. The trial enrolled 397 patients at 34 sites in the U.S. and Canada. At 6 months post-procedure, freedom from AVNRT was 92.6% and all safety endpoints were met, according to the release.

"Medtronic is pleased with the FDA's decision to approve the expanded use of the Freezor Xtra Catheter for the AVNRT patient population," Colleen Fowler, vice president and general manager of the AF Solutions business, part of the Cardiac and Vascular Group at Medtronic, said in the release. "This treatment option expands our efforts to improve care for these patients."

Disclosure: Wells reports serving as principal investigator for a trial sponsored by Medtronic. Fowler is an employee of Medtronic.