Less than a year after obtaining an FDA approval for its first foray into pulsed field ablation, Medtronic has done it again. The agency handed down a green light to the medtech giant’s all-in-one system offering both pulsed field and radiofrequency ablation alongside integrated heart mapping and navigation.
The Affera system, with its globular Sphere-9 catheter, was acquired by Medtronic in August 2022 through its $925 million purchase of the device’s eponymous developer. Not long thereafter, in early 2023, the company claimed a European approval with a CE mark for the dual-use platform in atrial fibrillation.
In the U.S., the approval covers the treatment of the irregular heartbeats caused by persistent afib as well as the delivery of RF thermal ablation for cavotricuspid isthmus-dependent atrial flutter.
"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,” Doron Harlev, former founder of Affera and current vice president of engineering for cardiac ablation at Medtronic, said in a statement.
“By enabling a single transseptal, 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,” Harlev added.
Medtronic said its PulseSelect system, the first pulsed field ablation device approved by the FDA back in December 2023, will continue to provide a single-shot solution for isolating the pulmonary vein, while Affera and Sphere-9 will offer a design that covers wider areas.
Pulsed field ablation works by delivering bursts of electric energy that disrupt the membranes of certain cells more than others, in this case the conductive cardiac muscle cells responsible for arrhythmias. The approach aims to avoid the harmful side effects that can come with less discriminate thermal ablation, which can damage neighboring nerves and tissues.
“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 Medtronic’s cardiac ablation business. “The potential of Affera is limitless.”
Earlier this month, the company also received a go-ahead from the FDA to launch a clinical trial of Affera and Sphere-9 for the treatment of sustained ventricular tachycardia in patients whose heart tissue has been scarred from a previous heart attack.
“Currently approved treatments for VT involve only RF energy and require physicians to use multiple mapping and ablation catheters with often long, inefficient procedure times,” Khaldoun Tarakji, M.D., Medtronic’s chief medical officer of cardiac ablation, said at the time. “PFA technology and the innovative Sphere-9 design could have a significant impact on patient care.”