DiamondTemp is indicated for the treatment of recurrent, symptomatic paroxysmal atrial fibrillation (AF) in patients who do not respond to drug therapy
FDA centre for devices and radiological health. (Credit: The U.S. Food and Drug Administration/Wikipedia.)
Medical technology firm Medtronic has secured the US Food and Drug Administration (FDA) approval of the DiamondTemp Ablation system to treat patients with a type of atrial fibrillation.
The ablation system is indicated for the treatment of recurrent, symptomatic paroxysmal AF in patients who do not respond to drug therapy.
DiamondTemp is a temperature-controlled open-irrigated RF ablation system, designed to provide irrigated radiofrequency (RF) energy during ablations, along with real-time feedback on physical parameters, which guide physicians while producing the lesion.
The medical device maker said that its DiamondTemp system is the first FDA approved, temperature-controlled, RF ablation system with diamonds, currently available to deliver ablations.
Medtronic 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.
“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 arrhythmia solutions to help patients control their AF.”
The DTA catheter is embedded with industrial-grade diamonds, which deliver 200-400 times more thermal conductivity compared to materials used in conventional RF ablation catheters.
The thermal conductivity enables reduced irrigation flow-rate, and precise real-time measurements of tissue temperature, facilitating effective energy delivery.
Medtronic said that its DiamondTemp system is safe and effective and has shown procedural efficiencies superior to conventional contact force-sensing RF catheters.
Also, it has specially designed the catheter for the recording of high-resolution electrogram (EGM) signals, which can be used by physicians as a physical indicator of lesion formation, and guidance for ablation location.
About DIAMOND-AF clinical trial of DiamondTemp Ablation system
The DIAMOND-AF trial is a multicentre, single-blind, non-inferiority, randomised, controlled trial that compared the safety and effectiveness of the DTA system to a contact force-sensing ablation system (control arm).
The study enrolled 482 patients with recurrent, symptomatic, paroxysmal atrial fibrillation (PAF), whose disease is not responsive to drug therapy, across 23 sites in the US, Europe and Canada.
The study results showed that the treatment using DiamondTemp system reduced the patient complication by 96.7% in the DTA group compared to 93.4% in the control.
Also, the system demonstrated the primary effectiveness of 79.1% for the AF treatment, compared to 75.7% of control subjects.
Furthermore, the system offers procedural advantages, including shorter total RF times, individual RF ablation duration, and reduction in the volume of infused saline, compared to the control group.