The U.S. Food and Drug Administration (FDA) has granted approval to Medtronic's Affera mapping and ablation system with the Sphere-9 catheter for the treatment of atrial fibrillation (AF). This system uniquely combines pulsed-field ablation and radiofrequency energy capabilities. The approval, announced last week, marks a significant advancement in electrophysiology, providing physicians with a versatile tool for managing persistent AF and cavotricuspid isthmus-dependent atrial flutter.
Medtronic now leads the field as the first company to offer two ablation systems capable of delivering pulsed-field energy, with its PulseSelect system already cleared by the FDA in December 2023 for paroxysmal and persistent AF. Boston Scientific's Farapulse system was also approved in January 2024.
The Affera system's approval is underpinned by data from the SPHERE Per-AF investigational device exemption (IDE) study, presented at the Heart Rhythm Society meeting and published in Nature Medicine. The study compared the Affera system to conventional radiofrequency ablation, demonstrating noninferior efficacy and safety, alongside shorter procedure times.
Mechanism of Action
Pulsed-field ablation is believed to offer a safer alternative to traditional radiofrequency or thermal ablation. It utilizes electroporation, a process that selectively targets myocardial tissue, thereby minimizing the risk of damage to adjacent structures such as the esophagus and phrenic nerve. This targeted approach is particularly advantageous in reducing complications associated with AF ablation procedures.
Clinical Evidence
The SPHERE Per-AF trial, a pivotal study supporting the Affera system's approval, highlighted the system's ability to achieve comparable outcomes to radiofrequency ablation while potentially improving safety profiles. The study's findings suggest that the Affera system could streamline AF ablation procedures, reducing overall procedure time and patient recovery.
Market Landscape
The introduction of the Affera system expands the options available to electrophysiologists for AF ablation. With both pulsed-field and radiofrequency capabilities, the Affera system offers flexibility in tailoring treatment strategies to individual patient needs. This approval strengthens Medtronic's position in the competitive market for AF ablation technologies.
The Affera system with Sphere-9 catheter received CE Mark approval in Europe in March 2023 and was approved in Australia last month.
