New Pulsed Field Ablation Devices Improve Patient Safety Profiles
- 13 hours ago
- 2 min read
Updated: 1 hour ago
The landscape of cardiac care is undergoing a seismic shift as Pulsed Field Ablation (PFA) moves from a novel alternative to a dominant force in treating atrial fibrillation (Afib). Predicted to account for nearly half of all Afib procedures by 2025, the market is currently experiencing explosive growth.
The PFA market is projected to expand at a Compound Annual Growth Rate (CAGR) of 24.2% through 2034. While current estimates place the global market between $700 million and 900million,analystsexpectittoexceed∗∗3 billion within the next five years**.
Key market characteristics include:
Dominant Modality: Catheter-based systems currently hold approximately 70% to 75% of the market share due to their precision and established use in electrophysiology labs.
Regional Leadership: North America, particularly the United States, is the primary driver of innovation and adoption, supported by robust healthcare infrastructure and favorable reimbursement policies.
Key Industry Players: Market leaders include Medtronic, Boston Scientific, and Johnson & Johnson, alongside innovators like Kardium and Acutus Medical.
Despite its rapid adoption, the industry faces significant scrutiny regarding safety profiles. The NEMESIS-PFA registry study recently challenged assumptions about PFA’s safety, linking first-generation devices to higher markers of non-target myocardial injury, hemolysis, and acute kidney injury compared to traditional radiofrequency ablation.
Furthermore, the rollout of Johnson & Johnson’s Varipulse system was briefly paused in early 2025 following reports of neurovascular events, though commercial use has since resumed with updated guidance.
The future of PFA also signals a shift in where patients receive care. The Centers for Medicare & Medicaid Services (CMS) recently added catheter ablation to the list of procedures covered in Ambulatory Surgical Centers (ASCs), paving the way for more widespread, cost-effective access to this life-changing therapy.
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Keywords: Pulsed Field Ablation
Pulsed Field Ablation
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