Medtronic's Affera System Receives FDA Approval for Persistent Atrial Fibrillation Treatment
Key Insights
Medtronic's Affera (search) mapping and ablation system secured FDA approval for treating persistent atrial fibrillation (search) (AFib (search)) by combining mapping with radiofrequency (RF) and pulsed field ablation (PFA).
The Affera (search) system's Sphere-9 catheter allows switching between RF and PF energy, integrated with mapping technology, potentially impacting point-by-point ablation procedures.
Analysts predict Affera (search) could threaten RF businesses of competitors like J&J (search) and Abbott, while increased PFA competition may pressure Boston Scientific's market share.
Medtronic has received FDA approval for its Affera (search) mapping and ablation system, a novel treatment for persistent atrial fibrillation (search) (AFib (search)). The system uniquely combines mapping technology with a catheter capable of delivering both radiofrequency (RF) and pulsed field ablation (PFA), offering a versatile approach to cardiac ablation.
The Affera (search) system distinguishes itself from existing PFA-only devices like Medtronic’s own PulseSelect (search) and Boston Scientific’s Farapulse (search) by integrating mapping capabilities and RF ablation. This combination allows physicians to map the heart's electrical activity and then choose the most appropriate ablation method – RF or PFA – based on the specific needs of the patient.
Affera's Technological Advantages
The Affera (search) system incorporates the Sphere-9 catheter, a wide area focal catheter that can switch between RF and PF energy. This dual-energy capability, coupled with integrated mapping technology, provides physicians with comprehensive control during ablation procedures. Previously, physicians often had to rely on third-party mapping systems, primarily from Abbott and J&J (search), when performing PFA procedures. The recent FDA approval of Boston Scientific's Farapulse (search) mapping system and now Medtronic's Affera system are changing this landscape.
According to Stifel analysts, Affera (search) represents a “meaningful upgrade” over Medtronic’s PulseSelect (search). One physician noted to Needham analysts that they anticipate shifting their PFA mix from 100% Farapulse (search) to 50% Affera, 30% Farapulse, and 20% Johnson & Johnson’s Varipulse (search) as these new devices become available.
Market Impact and Competition
The introduction of Affera (search) is expected to drive significant changes in the electrophysiology market. Abbott, for example, has seen accelerated growth due to the demand for its mapping technology alongside the launch of rival PFA devices. However, with Medtronic and Boston Scientific now offering integrated mapping systems, the competitive landscape is shifting.
Stifel analysts suggest that Affera (search) could significantly impact point-by-point ablation procedures, which are typically performed using RF energy and are currently dominated by J&J (search) and Abbott. In contrast, they believe Boston Scientific’s Farapulse (search) is best suited for single-shot, de novo ablation, while Affera’s point-by-point ablation approach may be more appropriate for other cases.
Needham analysts have identified increased PFA competition as a potential threat to Boston Scientific, citing potential price pressures and the likelihood of Boston Scientific losing market share. Boston Scientific, however, is preparing to present PFA data in persistent AFib (search), the patient population in which Medtronic tested Affera (search), and questions the assertion that dual-energy ablation is more efficient. Brad Sutton, Boston Scientific’s chief medical officer for AF solutions, stated that they believe they are “significantly more efficient with persistent application.”
Future Outlook
While the FDA approval of Affera (search) marks a significant milestone, Medtronic anticipates a limited financial contribution from the system in fiscal year 2025. CEO Geoffrey Martha has indicated that fiscal year 2026 is when the company expects to see a more substantial impact on revenue from Affera, citing ongoing efforts to improve manufacturing capabilities for the complex catheters.