Medtronic receives FDA approval for atrial fibrillation system

Medtronic has received Food and Drug Administration (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 a temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.

Atrial fibrillation is the most common heart rhythm disorder affecting 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.

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.

The DTA system is a temperature-controlled open-irrigated RF ablation system designed to deliver RF energy (heat) during ablations. The DTA system delivers real-time feedback on physical parameters, which can guide physicians as the lesion is being produced.

The DTA catheter is embedded with industrial-grade diamonds, which Medtronic says has 200-400 times greater thermal conductivity when compared to materials used in conventional RF ablation catheters. This thermal conductivity enables a low irrigation flow-rate, and real-time measurements of tissue temperature.  

The DTA catheter is specially designed for recording of high-resolution electrogram (EGM) signals. Physicians can use these clear EGM signals as a physical indicator of lesion formation, as well as guidance for ablation location.

Rebecca Seidel, president of Cardiac Ablation Solutions, part of the Cardiac and Vascular Group at Medtronic, said: "With the FDA approval of the DiamondTemp system, Medtronic continues to drive clinical research and innovation to find differentiated solutions that meet the needs of patients and clinicians, who are on the front lines of patient care. DTA is the only FDA-approved, temperature-controlled, irrigated RF ablation system on the market today. The addition of DTA will enable Medtronic to continue to expand our portfolio in new ways with cutting edge arrythmia solutions to help patients control their AF."