Medtronic's Sphere-360 Achieves 98% Durable Pulmonary Vein Isolation in Pivotal AFib Trial

• Sphere-360

Sphere-360 is a research-based, world-first single-shot PFA mapping and ablation catheter designed for the treatment of paroxysmal atrial fibrillation (PAF). This prospective single-arm trial conducted at multiple centers in Europe showed that in a subgroup of patients treated with an optimized waveform, the one-year follow-up results were as follows:

88% of patients had no recurrence of arrhythmia, 98% of target pulmonary veins achieved long-term durable isolation, and no safety events were reported.

PI Evaluation

"Affera Technology is a sophisticated ecosystem that includes an advanced intuitive mapping system and a seamlessly integrated catheter system, offering diversified treatment options for various types of arrhythmias. Sphere-360 allows for the effortless creation of circumferential lesions without catheter rotation, showing encouraging results in terms of safety and efficacy with zero serious adverse events. Once approved, it will become an important addition to Medtronic’s Affera System — a system that has already revolutionized atrial fibrillation treatment paradigms and clinical workflows."

---Vivek Reddy  Mount Sinai Health System

Medtronic Plans to Launch Pivotal Trial for Sphere-360 Catheter in the U.S. Later This Year

• Sphere-9

Medtronic's subgroup analysis of the Sphere Per-AF IDE study shows,Sphere-9 can safely and effectively create linear ablation lesions for patients with persistent atrial fibrillation.Such ablation is often used in conjunction with pulmonary vein isolation (PVI) to improve the success rate of restoring and maintaining normal heart rhythm in patients.

Executive Evaluation

"Upholding the innovative mission of 'patient-centered care,' we continuously provide doctors with cutting-edge technology to improve the care of atrial fibrillation patients—this progress never stops. These achievements mark the growing consolidation of our leadership in the electrophysiology field, inspiring us to continue advancing."

---Rebecca Seidel President of Cardiac Ablation Solutions, Cardiovascular Business Unit, Medtronic

Medtronic's PFA Technology Layout

Medtronic is currently the only company offering a dual PFA solution.:PulseSelect has been launched in more than 30 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, and New Zealand markets, and continues to advance its global expansion.

Sphere-360 Advantages

• The distal end of the spherical catheter is equipped with a 34-lattice spherical electrode, capable of delivering electrical pulse energy uniformly and efficiently.
• Perfectly integrated with the Affera mapping and ablation system, achieving low to zero fluoroscopy;
• Capable of adjusting the electrode shape according to the patient's physiological structure, thereby perfectly conforming to various anatomical structures of the pulmonary veins;
• Real-time local impedance information, used to evaluate the degree of catheter-tissue contact;

• Over-the-wireDesigned for easy pulmonary vein localization and simplified surgical procedures;

• Compared with 8.5FrAcQCrossSheath compatibility, achieving zero exchange during the procedure.