FDA Approves Medtronic Catheter Device to Treat Atrial Fibrillation

Kathleen Blanchard's picture

Medtronic announced FDA approval of a device that treats atrial fibrillation (AF) that sometimes can't be cured by drug therapy. The Arctic FrontĀ® Cardiac CryoAblation Catheter system is different than other devices used to knock out abnormal electrical signals in the heart that lead to the heart rhythm problem because it ablates electrical signals in the heart that cause irregular heartbeat using cold rather than heat.

Atrial Fibrillation Device Catheter Device Improves Outcomes

The catheter device, according to Medtronic, adheres better to tissue around the heart, compared to currently used ablation techniques that require electrophysiology studies and locating the exact area of abnormal electrical activity that can be difficult.

The new Cryoballoon treatment is minimally invasive. The catheter is more stable, helping cardiologists place it more accurately near openings around the pulmonary veins that supply oxygen to the heart and lungs. The new device makes ablating paroxysmal atrial fibrillation faster, less tedious and requires fewer scars in the heart tissue.


Vivek Reddy, MD, director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York, NY says, "This unique ablation approach fills an unmet need in AF ablation by providing a straightforward and efficient approach to pulmonary vein isolation, while giving patients a new, minimally-invasive treatment approach proven to be safe and effective."

The approval of the Medtronic catheter ablation system by the U.S. FDA stems from the success and safety found from the in the STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial. In the study, 69.9 percent of 245 patients treated for paroxysmal atrial fibrillation - brief, intermittent episodes- were free of the irregular heart rhythm after one year.

The results were compared to drug therapy that controlled atrial fibrillation in just 7.3 percent of patients. Just over three percent of patients in the study had adverse events. Five patients in the STOP AF trial developed pulmonary vein stenosis that requires additional treatment.

Other findings leading to approval of the Medtronic Cardiac CryoAblation Catheter system from the STOP AF trial included increased quality of life for the patients studied and treated who were relatively young and free of heart disease. All had frequent documented episodes of atrial fibrillation that can produce symptoms of fatigue, shortness of breath, low blood pressure and can increase the chances of developing blood clots in the heart chamber that can lead to stroke.