Medtronic's Affera mapping and ablation system, featuring the Sphere-9 catheter, has received FDA approval for the treatment of persistent atrial fibrillation (AF) and radiofrequency ablation of cavotricuspid isthmus-dependent atrial flutter. This innovative system is designed to deliver both radiofrequency and pulsed field ablation, offering electrophysiologists a versatile tool for addressing complex arrhythmias.
The approval was supported by data from the pivotal SPHERE Per-AF trial, a noninferiority study involving 420 patients with symptomatic persistent AF (mean age 67 years, 68% men). Patients were randomized to ablation with the Affera system or a conventional radiofrequency ablation system (Thermocool SmartTouch SF catheter with Carto navigation, Biosense Webster). The study demonstrated that the Affera system was noninferior to the conventional approach.
Key Features of the Affera System
The Affera system incorporates a wide area focal design with a 9 mm lattice tip, compatible with an 8.5 French sheath. This design facilitates efficient mapping and ablation. A notable feature is its ability to deliver both radiofrequency and pulsed field ablation, providing physicians with flexibility in choosing the optimal energy source for each patient.
According to Doron Harlev, vice president of engineering for cardiac ablation solutions at Medtronic and founder of Affera, the system was designed to address procedural challenges in electrophysiology while maintaining high safety and efficacy standards. The Sphere-9 catheter uniquely integrates mapping and ablation technologies, enabling a single transeptal, zero-fluoroscopy, and zero-exchange workflow.
Clinical Implications
Persistent atrial fibrillation poses a significant challenge to both patients and healthcare providers. Current treatment strategies often involve catheter ablation, aiming to isolate the pulmonary veins and other arrhythmogenic sources in the atria. The Affera system offers a novel approach by combining mapping and ablation capabilities in a single device, potentially streamlining the procedure and improving outcomes. The zero-fluoroscopy workflow is also expected to reduce radiation exposure for both patients and medical staff.
The SPHERE Per-AF trial compared the Affera system to the Thermocool SmartTouch SF catheter, a widely used radiofrequency ablation system. The noninferiority finding suggests that the Affera system is a viable alternative for patients with persistent AF. Further studies may be warranted to evaluate long-term outcomes and cost-effectiveness compared to existing ablation techniques.
