(By Balachander) Medtronic Inc. (NYSE:MDT) has received approval from the U.S. Food and Drug Administration (FDA) for its second balloon-based medical system to treat a type of heart rhythm disorder.
The Minneapolis, Minnesota-based company also announced CE Mark for the next-generation Arctic Front Advance Cardiac Cryoballoon system for the treatment of paroxysmal atrial fibrillation (PAF).
PAF is characterized by irregular heartbeats which start and stop suddenly on their own, usually for minutes or days at a time. Atrial fibrillation affects more than 7 million people worldwide and if left untreated, patients have up to a five times higher risk of stroke4 and an increased chance of developing heart failure.
Medtronic said the latest balloon-based medical technology "provides a more efficient approach to treating PAF than point-by-point, radiofrequency (RF) ablation."
The Arctic Front Advance Cryoballoon inflates and fills with coolant to ablate the tissue where the pulmonary veins enter the left atrium, the company noted.
The company's first-generation Arctic Front Cardiac CryoAblation Catheter System is approved in both the United States and Europe to treat PAF.
MDT shares traded nearly flat at $40.36 on Friday.