Medtronic’s new AFib ablation system gains FDA approval
Medtronic has received FDA approval for its DiamondTemp Ablation (DTA) system, a temperature-controlled solution designed to treat patients with recurrent atrial fibrillation (AFib).
The DTA system uses pulmonary vein isolation and can send real-time feedback to healthcare providers during the treatment process. The DIAMOND-AF clinical trial, which included nearly 500 patients, found no complications 96.7% of the time—higher than the control group’s 93.4%.
“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,” Rebecca Seidel, president of cardiac ablation solutions for Medtronic, said in a statement. “DTA is the only FDA-approved, temperature-controlled, irrigated radiofrequency ablation system on the market today.”
Results from the DIAMOND-AF trial were published in JACC: Clinical Electrophysiology. That full study is available here.