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Advancements in Atrial Fibrillation Treatment

Medtronic plc, a renowned name in healthcare technology, recently revealed encouraging clinical outcomes from two pivotal studies focusing on atrial fibrillation (AFib) patients. The company presented these findings at the 2025 Annual Meeting of the Heart Rhythm Society held in San Diego, highlighting its advanced Affera™ family of technologies, including the innovative Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ catheter.

Sphere-360 Study: Safety and Performance Evaluation

The Sphere-360 catheter is a pioneering single-shot mapping and ablation device that treats paroxysmal atrial fibrillation (PAF). Results from a one-year, multi-center trial conducted across various European locations show that 88% of patients experienced a significant reduction in arrhythmia recurrence. Additionally, the study reported a successful pulmonary vein isolation (PVI) rate of 98%, with no safety events noted among participants treated with the most optimized waveform. The design of the Sphere-360 is notably flexible, allowing it to adapt into various shapes while being integrated seamlessly with the Affera Mapping and Ablation System. Dr. Vivek Reddy, a prominent figure in cardiac arrhythmia services, praised the technology for its capacity to deliver circumferential lesions efficiently, without necessitating catheter rotation.

Sphere-9 Catheter: Enhancing Treatment for Persistent AF

Further analysis from the Sphere Per-AF IDE study demonstrated that the Sphere-9 catheter is both safe and effective for creating linear lesions in patients with persistent AF. This technique is crucial because linear ablation is often combined with PVI to enhance the likelihood of restoring a normal heart rhythm. The outcomes from the Sphere Per-AF IDE study were vital in securing FDA approval for the Affera system in October 2024.

Rebecca Seidel, president of Medtronic's Cardiac Ablation Solutions business, remarked on the company's commitment to delivering innovative healthcare technologies that substantially improve patient outcomes in AFib treatment. The Sphere-360 technology's impressive performance and safety profile signify a remarkable advancement in treatment options, making it a vital addition to Medtronic's existing offerings.

Expanding Access to Innovative Treatments

Medtronic is unique in presenting two PFA options to both patients and physicians. The PulseSelect™ Pulsed Field Ablation System is already available in over 30 countries, further establishing Medtronic's leadership in this domain. The Affera system, paired with the Sphere-9 catheter, offers treatment flexibility via its wide area focal design. Both systems have ongoing global expansions, emphasizing Medtronic's intention to provide advanced care to a broad patient base.

Atrial fibrillation is an increasingly prevalent heart rhythm disorder, affecting over 60 million individuals worldwide. The condition often evolves from intermittent paroxysmal AFib to persistent forms, increasing the risk of severe complications such as strokes and heart failure.

For more details on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Medtronic, headquartered in Galway, Ireland, is a global leader focused on tackling some of the most significant health challenges. With a mission to alleviate pain, restore health, and extend life, the company employs over 95,000 individuals worldwide and is committed to innovating advanced medical solutions across various health conditions. As recognized by its diverse portfolio, Medtronic seeks to transform healthcare experiences, giving priority to people and improving global health outcomes.