The FDA has approved Medtronic’s DiamondTemp irrigated ablation catheter, designed to treat patients with recurrent atrial fibrillation that has not responded to drug therapies.
The minimally invasive device is embedded with industrial-grade diamonds, allowing it to conduct heat energy much more efficiently than other commonly used materials—up to 200 to 400 times greater, according to Medtronic.
This allows for gentler irrigation of the ablation tip, rapid power modulation and more stable heat control as well as clearer measurements of the temperature of surrounding tissue.
The system also delivers real-time physical feedback to surgeons to help guide them as they create lesions in the heart muscle and pulmonary veins, and can help record high-resolution electrogram signals.
Medtronic picked up the closed-loop DiamondTemp catheter through its 2019 acquisition of EPIX Therapeutics, describing it at the time as “leapfrog technology in the RF cardiac ablation space,” according to the medtech giant’s president of cardiac ablation solutions, Rebecca Seidel. The device previously received a CE mark in 2017.
A previous non-inferiority trial evaluated the system’s performance against a contact force-sensing ablation catheter and enrolled 482 patients in the U.S., Canada and Europe.
Primary effectiveness measures were met in 79.1% of patients treated with the DiamondTemp system, while 3.3% saw complications, compared with 75.7% and 6.6%, respectively, of patients in the control group.
The system also showed shorter ablation durations and faster total procedure times, Medtronic said. The study’s results were recently published in the Journal of the American College of Cardiology.