Medtronic’s DiamondTemp Ablation System Receives FDA Approval for Treatment of Atrial Fibrillation

January 29, 2021—Medtronic announced it has received FDA approval of the DiamondTemp ablation (DTA) system, which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) who have been unresponsive to drug therapy.

The DTA system is a temperature-controlled, irrigated radiofrequency (RF) ablation system embedded with diamonds that is designed to deliver RF energy during ablations.

The company noted that the industrial-grade diamonds, which have 200 to 400 times greater thermal conductivity when compared to materials used in conventional RF ablation catheters, enable a low irrigation flow rate and accurate real-time measurements of tissue temperature, resulting in more efficient energy delivery. The real-time feedback on physical parameters can guide physicians as the lesion is being produced.

According to Medtronic, the DTA system is safe and effective and has demonstrated procedural efficiencies when compared to conventional contact force-sensing RF catheters. Additionally, the DTA catheter is specially designed for recording high-resolution electrogram signals that physicians can use as a physical indicator of lesion formation, as well as guidance for ablation location.

FDA approval was supported by findings from the DIAMOND-AF trial that were presented as a late-breaking clinical trial at the 2020 Asia Pacific Heart Rhythm Society Virtual Congress in October 2020. On January 27, 2021, the study was published online by Professor Josef Kautzner, MD, et al in the Journal of the American College of Cardiology: Clinical Electrophysiology.

The DIAMOND-AF trial is a prospective, multicenter, single-blind, noninferiority, randomized control trial that was 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 AF whose condition is unresponsive to drug therapy. The trial enrolled 482 patients (239 DTA, 243 control) across 23 sites in the United States, Europe, and Canada.

Medtronic stated that results demonstrated a freedom from patient complication rate of 96.7% in the DTA group versus 93.4% in the control (P < .0001 versus -6.5% noninferiority margin). Primary effectiveness for the treatment of AF was met in 79.1% of DTA and 75.7% of control patients (P < .0001 versus -12.5% noninferiority margin). Additionally, the DTA system demonstrated procedural advantages compared to the control group, with shorter total RF times and individual RF ablation duration, as well as reduction in volume of infused saline. A clinically meaningful quality of life improvement was also observed in both arms at 6 and 12 months postablation, reported Medtronic.

Tom McElderry, MD, the corresponding author for the study, commented in the company’s announcement, “The DIAMOND-AF trial results are encouraging not only because the DTA system was shown to be safe and effective but because the outcomes underscored significant procedural efficiencies for clinicians. Improved efficiencies, including shorter total RF ablation times and individual RF ablation durations, are important for both the well-being of the patient and the productivity of the physician and lab staff.”