Medronic Gets FDA OK for Diamond-Ablation System

Medtronic has received FDA premarket approval for its DiamondTemp ablation system, a device for treating recurrent, symptomatic paroxysmal atrial fibrillation in patients who do not respond to drug therapy.

The minimally invasive system uses radiofrequency (RF) energy to create scar tissue that interrupts irregular electrical signals in the heart, a procedure known as pulmonary-vein isolation.  The device also records high-resolution electrogram signals that serve as a physical indicator of lesion formation and help guide the ablation.

The company said its device is the first FDA-approved temperature-controlled, irrigated RF ablation system embedded with diamonds.