A new era of electrophysiology: Accelerating innovation for AFib with pulsed field ablation

Atrial fibrillation (AFib), the most common heart rhythm disorder, continues to rise globally - it is predicted to affect more than 12 million people in the US by 2030 and almost 18 million people in Europe by 2060.^1-2 With a growing aging population and an increased prevalence of heart disease, the demand for effective treatments for AFib is higher than ever before. Early detection and appropriate treatment can reduce AFib complications and improve patient quality of life.³

Historically, antiarrhythmic drugs (AADs) were the first-line therapy to maintain sinus rhythm, however, these medications are often ineffective, with around half of patients failing to respond.^4-5 Moreover, AADs can cause serious side effects, leading many patients to discontinue treatment.⁶

As a result, the American College of Cardiology and the American Heart Association upgraded catheter ablation as a first-line treatment for long-term rhythm control in 2023, offering a nonpharmacological alternative for those who do not respond to medications or electrical cardioversion.⁷  We continue to see evolution in the cardiac ablation landscape from the use of cryoablation and radiofrequency techniques to the emergence of pulsed field ablation (PFA) technology. This development represents a major breakthrough in the treatment of AFib, with the Sphere-9^TM catheter offering a safe⁸, effective⁸ and durable⁹ lesion and the PulseSelect^TM pulsed field ablation (PFA) system demonstrating precision and reproducible durability.¹⁰

In more than twenty years at Medtronic, I've had the privilege of leading and growing both businesses and teams. I’ve seen Medtronic evolve as a leader in electrophysiology, driving both organic and inorganic growth fueled by continuous, thoughtful innovation. Our steadfast commitment to advancing the field is evident in our ongoing efforts to introduce cutting-edge solutions. We first built the Cryoablation portfolio, establishing ourselves as leaders in pulmonary vein isolation. Today, we are at the forefront of PFA with two groundbreaking technologies, equipping physicians with the comprehensive tools they need to achieve the best possible outcomes for their patients.

The PulseSelect™ System Development Journey

In 2023, Medtronic marked a historic milestone with the FDA approval of the PulseSelect^TM PFA system – the first PFA technology to receive approval in the U.S. This achievement was the culmination of 15 years of research and waveform optimization, designed to seamlessly integrate with physician workflows and enable tailored therapy based on patients' needs. The PulseSelect system was not only an innovation in itself but also the first step in realizing our vision of providing disruptive electrophysiology solutions for patients, building on the foundation of our legacy Cryoablation portfolio and 75 years of innovation across Medtronic.

Recent data underscore the impressive durability and efficiency of the PulseSelect system, with 98% of pulmonary veins remaining isolated approximately two months after ablation.¹¹ The global adoption of the PulseSelect system has been broad, highlighting the technology's growing impact and potential to improve patient outcomes in the fight against AFib.

Building the Most Robust Portfolio in Electrophysiology

At Medtronic, discovery and innovation are at the heart of everything we do. Yet, we also understand that the true power of progress lies in collaboration. By strategically investing in both organic growth and inorganic opportunities, we can turbo-charge our ability to develop the latest and most impactful solutions for both physicians and patients. This philosophy guided our acquisition of Affera, Inc. in 2022 – a pivotal move that reinforced our commitment to building the most comprehensive and advanced portfolio in electrophysiology. This strategic acquisition allowed us to accelerate innovation, enabling the faster development and delivery of groundbreaking technologies to one of the fastest-growing markets in MedTech.

In October 2024, Medtronic received FDA approval for the Affera™ mapping and ablation system and Sphere-9™ catheter, solidifying our position as the only company to currently offer two FDA-approved PFA technologies. The Affera system, paired with the Sphere-9 catheter, is a game-changer in the treatment of persistent AFib and atrial flutter, combining pulsed field and radiofrequency ablation with high-density mapping in one powerful tool. This all-in-one catheter gives physicians the flexibility to tailor treatment to each patient’s needs in a safe, effective, and efficient manner, using different energy sources and mapping capabilities to effectively correct abnormal heart rhythms. In clinical trials, patients treated with the Sphere-9 catheter showed significant improvements in both mental and physical well-being, a testament to its impact on quality of life.⁸

We’re now shifting into a new gear in the speed of innovation, advancing early feasibility trials for the treatment of ventricular arrhythmias—a critical step toward expanding our reach to new, often undertreated patient populations. These efforts reflect a broader strategy: to build, buy, and continuously innovate to ensure we’re delivering solutions for patients and physicians across the full spectrum of electrophysiology needs. As we continue to advance the capabilities of the Affera system, Medtronic is focused on expanding its resources and expertise to meet the needs of physicians and patients around the world and leading the charge in transforming electrophysiology care.

Entering a New Era of Cardiac Ablation

The pace of innovation in electrophysiology is accelerating at an extraordinary rate, and the impact of these advancements on clinical practice is nothing short of transformative. The Affera mapping and ablation system with Sphere-9 catheter is reshaping the landscape of electrophysiology treatments. 

Physicians reported significant improvements in procedural efficiency, with the ability to map, ablate, and verify results during the same procedure—an unprecedented development in the field.⁸ As electrophysiologists encounter varied cardiac anatomies in patients, and as the population with AFib continues to rise, catheter versatility will become more important than ever for physicians and their patients. 

Medtronic’s long-standing tradition of driving disruptive innovation, and our commitment to addressing the unmet needs of patients, is stronger than ever. As the demand for effective AFib treatments grows, Medtronic is poised to lead the charge into an exciting new era of electrophysiology. The continued evolution of PFA and the integration of cutting-edge technologies like the Affera system marks the beginning of a transformative chapter in the treatment of AFib, one that holds immense promise for both physicians and patients alike.

Risks may include serious complications and injuries to cardiac and other body structures. The Affera™ mapping and ablation system and PulseSelect^TM pulsed field ablation (PFA) system should only be used by or under the supervision of a physician trained in pulsed field ablation and radiofrequency ablation procedures. Read important safety information here.