IRELAND – Medtronic has secured an approval from the Food and Drug Administration (FDA) for its Affera mapping and ablation system, designed to treat persistent atrial fibrillation (AFib).
This cutting-edge device integrates advanced mapping technology with a catheter that can perform both radiofrequency (RF) and pulsed field ablation (PFA), distinguishing it from other market offerings.
The Affera system combines multiple functionalities into a single platform, marking a significant advancement in the treatment of AFib.
According to Medtronic, the system not only addresses the irregular heartbeats associated with persistent AFib but also allows for RF thermal ablation aimed at treating cavotricuspid isthmus-dependent atrial flutter.
“By enabling a single transseptal, zero-fluoroscopy, and zero-exchange workflow, the Sphere-9 catheter uniquely integrates both mapping and ablation technologies,” explained Doron Harlev, Medtronic’s vice president of engineering for cardiac ablation.
He emphasized that the device offers physicians the flexibility to use either pulsed field or radiofrequency energy, significantly enhancing procedural efficiency.
Enhancing electrophysiology procedures
The Sphere-9 catheter, acquired by Medtronic in its US $925 million purchase of Affera in August 2022, represents a leap forward in electrophysiology.
Unlike previous systems, the Affera platform allows for a comprehensive mapping experience without relying on third-party systems, addressing a significant gap in the market.
Previously, physicians often had to utilize multiple systems for mapping PFA procedures, which complicated treatment processes.
With Affera’s integrated system, physicians can streamline their workflows, which may lead to improved patient outcomes and reduced procedure times.
Pioneering technology with dual abilation
PFA is emerging as a promising alternative to traditional thermal ablation techniques, which often result in collateral damage to surrounding tissues.
The Affera system’s ability to deliver bursts of electrical energy selectively disrupts the membranes of conductive cardiac muscle cells responsible for arrhythmias while preserving nearby healthy tissues.
Rebecca Seidel, president of Medtronic’s cardiac ablation business, expressed enthusiasm for the new system: “With the approval of Affera, we are excited to bring a novel mapping and ablation solution to clinicians that is intended to make atrial fibrillation treatment safer, more effective, and more efficient. The potential of Affera is limitless.”
Implications for the electrophysiology market
This approval comes at a pivotal time in the electrophysiology landscape, with competitors like Boston Scientific also launching PFA solutions.
As Medtronic and Boston Scientific continue to innovate, the market is poised to evaluate the efficiency and effectiveness of dual-energy ablation techniques versus traditional methods.
Medtronic CEO Geoffrey Martha noted that while the Affera system will make a limited contribution to the company’s fiscal 2025 revenue, significant growth is anticipated by fiscal 2026.
“We have work to do on supply, but we have made breakthroughs on manufacturing capabilities,” he added, addressing concerns about the complexity of producing the new catheters.
Looking ahead, Medtronic is also gearing up to initiate a clinical trial for the Affera system in treating sustained ventricular tachycardia, which could expand the device’s applications.
