Medtronic has secured approval for its DiamondTemp Ablation (DTA) system from the US Food and Drug Administration (FDA) for treating patients with atrial fibrillation (AF).
As the first temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds, the DTA system will be used for treating patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and those who have been unresponsive to drug therapy.
It uses radiofrequency energy and is a minimally invasive approach to create lesions (scar tissue), using heat, to interrupt irregular electrical signals in the heart.
The procedure is known as pulmonary vein isolation (PVI).
Medtronic noted that the DTA system is an open-irrigated RF ablation system, delivering RF energy (heat) during ablations. It can also deliver real-time feedback on physical parameters, guiding the physicians as the lesion is being produced.
The DTA catheter is embedded with industrial-grade diamonds, which are 200 to 400 times higher in thermal conductivity compared to other materials used in regular RF ablation catheters.
The use of diamonds further makes the DTA system safe and effective as it has shown procedural efficiencies compared to regular contact force-sensing RF catheters.
Furthermore, the system can record high-resolution electrogram (EGM) signals. Physicians can use these EGM signals as a physical indicator of lesion formation and guidance to locate the ablation.
Medtronic Cardiac and Vascular Group Cardiac Ablation Solutions president Rebecca Seidel 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.
“The addition of DTA will enable Medtronic to continue to expand our portfolio in new ways with cutting-edge arrhythmia solutions to help patients control their AF.”
Last November, Medtronic acquired a 90% stake in Medicrea International, a France-based artificial intelligence (AI)-enabled spinal implant manufacturer.