Medtronic’s newest all-in-one PFA catheter gains critical approval
Medtronic has secured CE mark approval for its Affera Sphere-360 catheter, an all-in-one mapping and single-shot pulsed field ablation (PFA) device designed to treat paroxysmal atrial fibrillation.
The Sphere-360 catheter has a distinct lattice design that can be modified into a variety of shapes. It utilizes an 8.5 French sheath and was built to integrate with Medtronic’s Affera Mapping and Ablation System, which the U.S. Food and Drug Administration (FDA) approved in October 2024.
According to Medtronic, the development of the Sphere-360 catheter was guided by physician feedback. Electrophysiologists wanted a convenient, easy-to-use device capable of adapting as needed and delivering PFA energy to a wide variety of patients; they also wanted to perform PFA procedures without needing to rotate the catheter again and again.
“The Sphere-360 catheter offers an excellent balance between ease of use and consistency in outcomes. Its design conforms to the pulmonary vein in a unique way that delivers consistent, effective and durable lesions for AFib patients, without any rotation of the catheter,” Tobias Reichlin, MD, director of electrophysiology at University Hospital of Bern in Switzerland, said in a statement. “With the full integration into the Affera mapping system, it's an exciting step forward for patient care in Europe.”
Medtronic also announced that early cases have been completed for the Horizon 360 investigational device exemption (IDE) pivotal trial, a single-arm study focused on the safety and effectiveness of the Sphere-360 catheter in patients at multiple facilities throughout the United States. The FDA has not yet approved the Sphere-360 device.
“The achievement of CE mark for Sphere-360, as well as the first cases in the U.S. IDE trial, mark two major achievements in our effort to deliver new and better treatments to AFib patients,” Rebecca Seidel, president of Medtronic’s cardiac ablation solutions business, said in the same statement. “We're committed to leading in PFA and bringing meaningful innovation at a regular cadence.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.