Medtronic plc, a global leader in healthcare technology, today announced the first enrollment in the REAL-Pulse global registry for the PulseSelect™ pulsed field ablation (PFA) system, the only pulsed field ablation (PFA) system approved to treat both paroxysmal and persistent atrial fibrillation (AFib). The global registry is a prospective, global, multi-center, observational post-market study to collect clinical performance and safety data in a broad patient population treated with the PulseSelect system. Patients will be followed for a minimum of 12 months post-procedure.

The first patient enrolled in the global registry was treated by Dr. Peggy Jacon, part of a team led by Dr. Pascal Defaye, at University Hospital in Grenoble, France.

“The rapid adoption of PFA is an exciting moment in electrophysiology, and we are pleased to participate in the long-term analysis of patient outcomes for this important innovation,” said Pascal Defaye, MD, Head of Rhythmology and Cardiac Stimulation, University Hospital, Grenoble, France. “PulseSelect fits seamlessly into our workflow and has been an excellent tool for tailoring treatment to patients. We look forward to ongoing use of this technology for our Afib patients.”

PulseSelect is commercially available in multiple major markets, including the United States, Europe, New Zealand, Canada, and the Middle East. Approval in Japan was received in May 2024.

"The Pulsed AF trial of the PulseSelect system demonstrated unmatched safety and impressive efficacy in treating patients with both paroxysmal and persistent AF. The REAL-Pulse Registry is an important step forward to prospectively analyze the long-term outcomes and benefits of PulseSelect in the real world and reflects our commitment to providing the best clinical evidence to support patient care," said Khaldoun Tarakji, MD, MPH, vice president, chief medical officer, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. “We are pleased to begin registry data collection with our esteemed partners in France and look forward to expanding enrollment globally.”

About Atrial Fibrillation and Pulsed Field Ablation
AF is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide¹. AF is a progressive disease, meaning it can become worse over time and can increase the risk of serious complications including heart failure, stroke and increased risk of death.^2-5 Prior to PFA, ablation technologies relied on thermal effects to target cardiac tissue and risk damage to additional collateral structures in the heart. PFA uses pulsed electric fields to efficiently isolate the pulmonary veins for the treatment of AF. Because the mechanism of cell death is non-thermal, the risk of collateral structure damage is potentially lower.  

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com, and follow @Medtronic on LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
4. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

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