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# Medtronic PMA OK’d for DiamondTemp Ablation
- URL: https://www.fdaweb.com/medtronic-pma-okd-for-diamondtemp-ablation/
- Published: 2021-01-29T12:00:00.000Z
- Updated: 2026-09-14T16:44:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148557

FDA has approved a Medtronic PMA for the DiamondTemp Ablation (DTA) system for treating patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) who have been unresponsive to drug therapy. The device is a temperature-controlled open-irrigated radiofrequency (RF) ablation system designed to deliver RF energy during ablations, Medtronic says, adding that it delivers real-time feedback on physical parameters, which can guide physicians as the lesion is being produced. It is embedded with industrial-grade diamonds, which have 200-400 times greater thermal conductivity when compared to materials used in conventional RF ablation catheters. “This thermal conductivity enables a low irrigation flow-rate, and accurate real-time measurements of tissue temperature, resulting in more efficient energy delivery,” it says.

Approval was based on data from the DIAMOND-AF trial. Results demonstrated a freedom from patient complication rate of 96.7% in the DTA group versus 93.4% in the control group. And primary effectiveness for the treatment of AF was met in 79.1% of DTA patients compared with 75.7% of control subjects.