Medtronic Receives FDA Approval of DiamondTemp Ablation System for the Treatment of Patients with Atrial Fibrillation

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Medtronic plc, the global leader in medical technology, announced it has received U.S. FDA approval of the DiamondTemp™ Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.

Atrial fibrillation is the most common heart rhythm disorder affecting nearly six million people in the U.S.1 and more than 37 million people worldwide.2 The disease involves irregular quivering or rapid heart rhythms in the upper chambers (atria) of the heart. AF ablation is a safe and effective treatment to reduce symptoms and improve quality of life.3

AF ablation using radiofrequency energy is a minimally invasive approach that aims to create lesions (scar tissue), using heat, to interrupt irregular electrical signals in the heart, a procedure known as pulmonary vein isolation (PVI). Since the pulmonary veins are often a major source of the arrhythmia, PVI via catheter ablation remains the cornerstone treatment for AF patients who are unresponsive to drug therapy.3