FDA expands indication for Medtronic’s Freezor Xtra cryoablation catheter

Medtronic (NYSE:MDT) said today that it won an expanded indication from the FDA for its Freezor Xtra cryoablation catheter for treating atrioventricular nodal re-entrant tachycardia.

Fridley, Minn.-based Medtronic said the Freezor Xtra catheter is a flexible, single-use device used to freeze cardiac tissue and block unnecessary electrical signals within the heart.

“Medtronic is pleased with the FDA’s decision to approve the expanded use of the FreezorXtra catheter for the AVNRT patient population,” AF solutions GM Colleen Fowler said in prepared remarks. “This treatment option expands our efforts to improve care for these patients.”

“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,” added principal investigator Dr. Peter Wells of the Baylor Heart & Vascular Hospital in Dallas.

Medtronic said the 397-patient Icy-AVNRT study showed freedom from AVNRT of 92.6% at 6 months for the Freezor Xtra-treated cohort.

Yesterday Medtronic said it won an expanded indication from the FDA for its OsteoCool RF ablation device for palliative treatment of metastases in all bony anatomy.

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