Radiofrequency ablation system for paroxysmal AF gains FDA approval
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Medtronic announced the FDA approved its temperature-controlled, irrigated radiofrequency ablation system with diamonds for the treatment of paroxysmal atrial fibrillation that is unresponsive to drug therapy.
According to a press release, the ablation system (DiamondTemp, Medtronic) is designed to deliver radiofrequency energy during ablations and provides real-time feedback on physical parameters to guide physicians as the lesion is being produced.
The catheter is embedded with industrial-grade diamonds with greater thermal conductivity compared with materials used in conventional radiofrequency ablation catheters, the company stated in the release.
According to the release, the thermal conductivity enables a low irrigation flow rate and accurate real-time measurements of tissue temperature.
"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 Medtronic’s Cardiac Ablation Solutions business, said in the release. "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 arrythmia solutions to help patients control their AF."
The approval was based on the results of the DIAMOND-AF trial, a prospective, multicenter, single-blind, noninferiority, randomized, controlled trial designed to compare the safety and effectiveness of the new ablation system with a contact force-sensing ablation system.
According to the release, researchers observed a freedom from patient complication rate of 96.7% in the radiofrequency ablation group compared with 93.4% in the force-sensing arm (P < .0001 vs. –6.5% non-inferiority margin). Primary effectiveness for the treatment of AF was met in 79.1% of radiofrequency ablation group and 75.7% in the force-sensing arm (P < .0001 vs. –12.5% non-inferiority margin).
"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," Tom McElderry, MD, section chief of electrophysiology and co-director of the heart and vascular center at the University of Alabama in Birmingham, said in the release. "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."
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