Medtronic plc (MDT) said Friday it received approval from the U.S. Food and Drug Administration or FDA for the DiamondTemp Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy.
According to Medtronic, the DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency or 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. and more than 37 million people worldwide.
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.
The DIAMOND-AF trial is a prospective, multicenter, single blind, non-inferiority, randomized, controlled trial designed to compare the safety and effectiveness of the DTA system against a contact force-sensing ablation system (control arm) for the treatment of patients with recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) whose condition is unresponsive to drug therapy.
The trial enrolled 482 patients across 23 sites in the U.S., Europe and Canada. DIAMOND-AF is the largest completed AF ablation technology IDE trial which resulted in FDA approval to date.
Results demonstrated a freedom from patient complication rate of 96.7 percent in the DTA group versus 93.4 percent in the control arm. Primary effectiveness for the treatment of AF was met in 79.1 percent of DTA and 75.7 percent of control subjects.
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