Medtronic Launches Sphere-360™: World’s First Integrated Mapping and Single-Shot PFA Catheter for Paroxysmal Atrial Fibrillation

Jan 23, 2026 22:10 CST Updated 22:10

Medtronic

Medical Device Manufacturer

Medtronic announces its first-ever integrated mapping and single-shot pulsed field ablation (PFA) catheter---Sphere-360Approved by the FDA for marketing, applicable toTreatment of paroxysmal atrial fibrillation.

In addition, Medtronic alsoCompletion of the Horizon 360 IDE Study Conducted in the U.S.First Clinical Enrollment.

PI Evaluation

"The Sphere-360 catheter achieves an excellent balance between operational convenience and consistent efficacy. Its design uniquely conforms to the pulmonary veins, providing stable, effective, and long-lasting lesion formation for atrial fibrillation patients without the need for catheter rotation. Combined with full integration with the Affera mapping system, this represents an exciting advancement in patient care across Europe."

---Tobias Reichlin Inselspital University Hospital

"Advances in electrophysiology over the past few years have had a profound impact on the treatment of patients with arrhythmias, and Affera technology is a key part of that. Today, Sphere-360 brings us a new differentiated single-shot PFA catheter, which is expected to drive the next phase of innovation. This is an exciting time for both physicians and patients, as our exploration is accelerating."

---Vivek Reddy Mount Sinai Health System

Executive Evaluation

"Sphere-360 Receives CE Approval and Completes First Cases in U.S. IDE Trial, Marking Dual Breakthroughs in Our Mission to Provide Better Treatment Options for Atrial Fibrillation Patients. We Are Committed to Leading the Development of PFA and Continuously Delivering Meaningful Innovations."

---Rebecca Seidel President of Cardiac Ablation Solutions Business under Medtronic's Cardiovascular Division

WithSphere-360ListedCurrently, Medtronic has become the world's only company capable of providing three types of PFA ablation technologies.Medtronic is currently the only company offering a dual PFA solution.:PulseSelect has been launched in 35 countries, providing a safe single-treatment solution for pulmonary vein isolation; while the Affera system, equipped with the Sphere-9 catheter, offers flexible treatment options for operators with its large focal design and 9mm lattice tip compatible with 8.5Fr sheaths. The system has entered the U.S., European, Australian, New Zealand, and Japanese markets, with ongoing global expansion.

DespitePulseSelect is the first product to receive FDA approval for market release and is also capable of achieving pulmonary vein isolation.One-time complete ablation. However, after the product is launched, compared with Boston ScientificFARAPULSE seems to be struggling in the competition. Therefore, to compete with Boston Scientific, it is necessary to showcase cutting-edge technology.Sphere-360Is the key to Medtronic's turnaround, and alsoMedtronicAchieve pulmonary vein isolation in the future (truly one-shot complete ablation). MoreoverSphere-360It can also achieve integrated ablation mapping, zero exchange, thereby significantly simplifying the surgical process and shortening the operation time.

Medtronic and Boston Scientific Competition, asSphere-360The market launch is expected to become increasingly intense.Sphere-360Capable of changing the market landscape.

Sphere-360

Sphere-360It is a novel 7F multi-segment grid-like spherical catheter designed to effectively provide pulmonary vein isolation. It can be used in conjunction with other Medtronic products.To become a supplement to the already listed PFA product line.

Sphere-360The design meets the doctors' needs for simplified, differentiated workflows and the use of a single catheter to accommodate pulmonary vein anatomical variations to achieve predictable efficacy.Sphere-360Seamlessly integrated with the Affera mapping and ablation system, featuring an adjustable mesh design that conforms to the pulmonary vein anatomy, allowing energy delivery without the need to rotate the catheter at each point.

Sphere-360 Advantages

Efficient Workflow: 34mm Mesh ElectrodeIt can form a complete and continuous circular lesion without rotation, improving surgical efficiency.
Anatomical Adaptation: The adjustable mesh structure can conform to the patient's pulmonary vein anatomy.
Integrated Operation: A single atrial septal puncture can complete navigation, mapping, and ablation without the need for catheter exchange.
Real-time Tissue Contact Feedback: Real-time assessment of catheter-tissue contact through localized impedance information
Stable and Accessible: Lead-assisted design enhances stability and facilitates entry into the pulmonary vein.
Strong compatibility: Compatible with FlexCath Contour 10 French steerable sheath, facilitating catheter positioning.

Medtronic

Medtronic is one of the largest medical technology, services, and solutions companies in the world, alleviating pain, restoring health, and extending life for millions of people globally. With over 90,000 employees worldwide, Medtronic serves doctors, hospitals, and patients in more than 150 countries. The company is committed to collaborating with stakeholders around the world to advance healthcare.