Medtronic has secured FDA approval for its Affera mapping and ablation system, which includes the Sphere-9 catheter, marking a significant advancement in the treatment of atrial fibrillation (AFib) and atrial flutter. This all-in-one system provides high-density mapping, pulsed field ablation (PFA), and radiofrequency (RF) ablation capabilities, offering a comprehensive solution for electrophysiologists treating complex cardiac arrhythmias.
The Affera system is now cleared for treating persistent AFib and cavotricuspid isthmus (CTI) dependent atrial flutter. Medtronic is also pursuing studies to expand the system's application to include ventricular tachycardia (VT). The Sphere-9 catheter, integral to the Affera system, allows physicians to choose between PFA and RF energy delivery, enhancing workflow efficiency and potentially improving patient outcomes.
Dual Energy Modalities
The Sphere-9 focal catheter's design integrates both PF and RF energy delivery options, fully compatible with the Affera mapping and ablation system. This dual modality provides physicians with the flexibility to tailor treatment strategies based on individual patient needs and anatomical considerations. The 9mm lattice tip of the Sphere-9 catheter is designed to work with an 8.5Fr sheath, facilitating precise and efficient ablation.
Rebecca Seidel, president of the Cardiac Ablation Solutions business at Medtronic, emphasized the company's commitment to addressing unmet needs in cardiovascular care. "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 Seidel.
Clinical Trial Data
The FDA's approval was supported by data from the pivotal SPHERE Per-AF study, an FDA IDE trial. This study compared the Sphere-9 with Affera to the J&J Thermocool SmartTouch SF RF ablation catheter with Carto 3 mapping, demonstrating the safety and efficacy of the Medtronic system.
Doron Harlev, Affera founder and now VP of engineering for Cardiac Ablation Solutions at Medtronic, highlighted the system's innovative 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 Harlev. "By enabling a single transeptal, zero-fluoroscopy, and zero-exchange workflow, the Sphere-9 catheter uniquely integrates both mapping and ablation technologies, offering the flexibility to use either pulsed field or radiofrequency energy."
Competitive Landscape
Medtronic's acquisition of Affera in August 2022 for $1 billion has positioned the company as a key player in the rapidly evolving ablation technology market. With the Affera system's approval, Medtronic now boasts two PFA technologies, including the PulseSelect PFA system, which was the first PFA system to receive FDA approval. Other companies, including Boston Scientific and Johnson & Johnson MedTech, are also developing and commercializing PFA technologies, intensifying competition in this space. Boston Scientific's Farapulse system gained FDA approval in January.
BTIG analysts Marie Thibault and Sam Eiber noted that the approval timeline was in line with expectations. They anticipate that Johnson & Johnson's Varipulse will also receive FDA approval soon, following its submission in March. The analysts also expressed optimism about the adoption of PFA technologies, stating, "We remain bullish on PFA and continue to expect rapid commercial uptake in the U.S. as devices launch and new systems are approved."
