Medtronic has received FDA approval for its Affera mapping and ablation system, which includes the Sphere-9 Catheter. This all-in-one system is designed for high-density mapping, pulsed field (PF), and radiofrequency (RF) ablation in the treatment of persistent atrial fibrillation (AF) and RF ablation of cavotricuspid isthmus (CTI)-dependent atrial flutter. The approval marks a significant advancement in electrophysiology, providing physicians with a versatile tool for managing complex cardiac arrhythmias.
With this approval, Medtronic is now the only company offering two PFA technologies for AF patients. The PulseSelect system, approved in December 2023, provides a single-shot solution for pulmonary vein isolation (PVI), while the Affera Sphere-9 catheter offers physicians treatment flexibility with its wide-area focal design and 9mm lattice tip, usable with an 8.5Fr sheath.
Clinical Impact and Physician Perspective
"The Affera system provides physicians with one safe, effective, and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients," said Vivek Reddy (Mount Sinai Health System, New York, USA). He also noted the system's short learning curve for experienced physicians, suggesting broad applicability in treating AF.
The Sphere-9 catheter integrates PF and RF energy delivery within the Affera mapping and ablation system, enhancing workflow efficiency while maintaining safety and efficacy.
Technical Details and Design
"The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients," said Doron Harlev, vice president of engineering for Cardiac Ablation Solutions at Medtronic and founder of Affera. The Sphere-9 catheter uniquely integrates mapping and ablation technologies, offering the flexibility to use either pulsed field or radiofrequency energy in a single transseptal, zero-fluoroscopy, and zero-exchange workflow.
Pivotal Study and Further Applications
The FDA approval was based on the SPHERE Per-AF study, an IDE trial comparing the Sphere-9 catheter with the Affera system to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto3 system (Biosense Webster). The Affera system and Sphere-9 catheter also received CE mark in March 2023 and approval in Australia in September 2024. Medtronic initiated an early feasibility study in October 2024 to evaluate the Sphere-9 catheter for treating ventricular tachycardia (VT).
Medtronic's Commitment to Innovation
"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," said Rebecca Seidel, president of the Cardiac Ablation Solutions business at Medtronic. She emphasized the company's commitment to innovation and addressing unmet patient needs in cardiovascular care.
