FDA approves shorter, third-gen cryoballoon

The FDA approved Medtronic’s latest generation cryoablation catheter for treating patients with paroxysmal atrial fibrillation. The Arctic Front Advance ST also received CE mark in Europe for a broader indication.

In the U.S., the cryoballoon system is approved for patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation and in Europe, in patients with atrial fibrillation.

The second-generation cryoballoon earned high marks for efficacy in a nonrandomized European study that compared it to a first-generation device in patients with paroxysmal atrial fibrillation. A higher proportion of patients had pulmonary veins completely isolated the first time with the newer device, with a shorter procedural time, shorter time to pulmonary vein isolation and a shorter duration to exposure to fluoroscopy. But the newer device also had a higher rate of phrenic nerve palsy.  

The tip of the third-generation Arctic Front Advance ST Cryoballoon Catheter is 40 percent shorter than its predecessor, which facilitates maneuverability and allows electrophysiologists to visualize the ablation in real time, according to Medtronic. The company announced that it will initiate a limited release of the device, which will become broadly available this fall.