Medtronic has received FDA approval for its Affera mapping and ablation system for the treatment of persistent atrial fibrillation (AFib), marking a significant advancement in electrophysiology. The Affera system distinguishes itself by integrating mapping technology with a catheter capable of delivering both radiofrequency (RF) and pulsed field ablation (PFA). This approval positions Medtronic to compete more effectively in the rapidly evolving AFib treatment landscape.
Affera's Unique Capabilities
The Affera system's wide area focal Affera Sphere-9 catheter can switch between RF and PF energy and is integrated with mapping technology. This eliminates the need for physicians to rely on third-party mapping systems, which were previously required when performing PFA procedures. The integration of both RF and PFA capabilities in a single device offers physicians greater flexibility in tailoring treatment strategies to individual patient needs.
Medtronic's single-shot Pulseselect system became the first FDA-approved PFA device in December 2023, but it lacks mapping capabilities or the option to deliver RF energy from the catheter. Affera addresses those capability gaps. Medtronic closed a $925 million takeover of Affera and its cardiac ablation and mapping devices in 2022.
Market Impact and Competition
The approval of Affera is expected to drive further changes in the electrophysiology market. Stifel analysts suggest that Affera could significantly impact point-by-point ablation procedures typically performed with RF energy, a field dominated by Johnson & Johnson and Abbott. The ability to perform both RF and PFA with integrated mapping could provide Medtronic with a competitive edge.
Needham analysts have identified increased PFA competition as a potential threat to Boston Scientific. They noted the potential for price pressure and, quoting a physician who expects to use Farapulse in 30% of PFA cases, said they think it is inevitable that Boston Scientific loses meaningful market share.
Future Outlook
While Medtronic anticipates a limited financial contribution from Affera in fiscal year 2025, CEO Geoffrey Martha stated that fiscal year 2026 is "where you'll start to feel the impact of Affera revenue ramp." The company has been working to address manufacturing complexities and expects to see increased adoption of the Affera system as supply chain issues are resolved.
Boston Scientific is preparing to present PFA data in persistent AFib, the population in which Medtronic tested Affera, and has challenged the idea that dual energy ablation is more efficient. Brad Sutton, Boston Scientific’s chief medical officer for AF solutions, said at a Wells Fargo event in September, “I would bet that we're significantly more efficient with persistent application.”
