FDA Approves Dual-Energy System for AF Ablation

The US Food and Drug Administration has approved a third pulsed-field ablation system, one that can also deliver radiofrequency energy, for the treatment of atrial fibrillation (AF), device maker Medtronic announced last week.

The Affera mapping and ablation system with Sphere-9 catheter is indicated for the treatment of persistent AF and—using radiofrequency energy—for ablation of cavotricuspid isthmus-dependent atrial flutter.

Medtronic is now the first company to have two ablation systems capable of delivering pulsed-field energy on the market, with its PulseSelect system gaining the FDA’s clearance in December 2023 for use in paroxysmal and persistent AF.

Electrophysiologists also have the Farapulse system (Boston Scientific), approved in January 2024, to turn to for pulsed-field ablation.

The modality is believed to be safer than conventional radiofrequency or thermal ablation because it works through electroporation, which is more specific for myocardial tissue, thus limiting damage to surrounding structures like the esophagus and phrenic nerve.

The Affera approval is based on the results of the SPHERE Per-AF investigational device exemption (IDE) study, which was presented at the Heart Rhythm Society’s annual meeting in May and published in Nature Medicine. Compared with conventional radiofrequency ablation, ablation with the Affera system provided noninferior efficacy and safety, with shorter procedure times.

The Affera system with Sphere-9 catheter received CE Mark approval in Europe in March 2023 and was approved in Australia last month.