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# Medtronic Gets OK for PulseSelect Ablation Trial
- URL: https://www.fdaweb.com/medtronic-gets-ok-for-pulseselect-ablation-trial/
- Published: 2020-01-23T12:00:00.000Z
- Updated: 2026-09-14T15:59:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145916

FDA has given Medtronic approval to proceed with an IDE trial (PULSED AF) to evaluate the safety and effectiveness of the PulseSelect Pulsed Field Ablation (PFA) System, a new technology that uses pulsed electric fields to treat atrial fibrillation. The company says that PFA uses pulsed electric fields to ablate or create lesions and scar tissue to interrupt irregular electrical pathways in the heart and the triggers of atrial fibrillation. “However, unlike traditional methods of ablation that heat the tissue (radio frequency) or cool the tissue (cryo) to ablate, PFA is non-thermal and selectively targets cardiomyocytes (heart muscle cells) while avoiding other types of tissue,” it says. In 2018, FDA granted Medtronic a breakthrough device designation for the PFA technology.