Pulsed Field Ablation: Innovation, Adoption, and the Patent Challenges

Pulsed Field Ablation (PFA), a non-thermal energy technique that ablates heart tissue using microsecond high-voltage pulses, is a transformative technology in the treatment of atrial fibrillation (AF). With the potential to offer safer, faster, and more effective procedures than traditional heat-based ablation, PFA has drawn the attention of major medtech players and innovative startups alike. As the field evolves, competition is intensifying not only in technological innovation but also in securing robust intellectual property protection, particularly given the legal and regulatory differences between the US and Europe.

The Rise of PFA in Cardiac Ablation

Traditional catheter ablation uses thermal energy (either radiofrequency (RF) heating or cryo-freezing) to create lesions that block abnormal electrical signals. PFA instead uses short, high-voltage electrical pulses to create microscopic pores in cell membranes (irreversible electroporation), leading to targeted heart muscle cell death. Crucially, this effect is highly tissue-selective: cardiac muscle cells are particularly susceptible, while surrounding structures such as the oesophagus, phrenic nerve, and blood vessels are far more resistant. This selectivity allows for more precise ablation with minimal impact on surrounding areas, allowing for a faster recovery.
 
Electroporation itself is not new. In fact, reversible electroporation has long been used in other areas of medicine, such as gene therapy, where temporary pores are created in cell membranes to allow the delivery of drugs or genetic material. The key distinction lies in the pulse parameters: reversible electroporation (RE) uses lower energy levels and/or shorter durations, allowing the pores to reseal after a short time and cells to survive, whereas irreversible electroporation (IRE) employs high-intensity, short duration electric fields to ensure permanent cell damage. 

Several key factors influence lesion formation: field strength (typically 500–2,000 V/cm), pulse number, pulse duration (typically microseconds), electrode configuration and tissue conductivity.  Local electric field distribution can also be influenced by other factors such as heterogeneity of anatomical targets, tissue anisotropy and impedance variability. Catheter design, electrode configuration, and energy delivery protocols are of importance for cardiac PFA.

Early clinical data suggests PFA is as effective as RF- or cryo-therapy for the treatment of AF, with potentially superior safety (fewer complications such as pulmonary vein stenosis) and significantly shorter procedure timesⁱ,ⁱⁱ. This has generated tremendous buzz in the electrophysiology community, fuelling rapid adoption of PFA technology.

Market analysis

The promise of PFA is reflected in the surge of investment and R&D activity. Major companies, including Boston Scientific, Medtronic, Abbott, and Johnson & Johnson, have launched or acquired PFA technologies, while smaller startups like Acutus Medical and Del Medtech, are rapidly innovating to carve out their niche. Pulse Biosciences, for example, is extending the technique to cardiac surgery; developing a clamp that surgeons can use to deliver pulses during open-heart procedures.  While thermal ablation is cooling down, the competitive landscape is certainly heating up.

Table 1 The table below summarizes some of the major PFA players and their platforms in the cardiac ablation market

But pulsed-field energy isn’t limited to cardiology. Companies like Galvanize Therapeutics are leveraging similar IRE technique for tumour ablation and even pulmonary diseases. The crossover of electroporation technology from oncology to cardiology means there is a broad base of knowledge and intellectual property that cardiac PFA developers can draw on or must work around (more on that below).

Overall, the outlook for the cardiac ablation market in the next 2 - 3 years is one of dynamic growth. The rapid adoption of PFA, combined with the entry of multiple competitors, underscores how critical innovation is in this space, not just in device performance but in intellectual property and regulatory strategy.

Patent Applications and Patentability Challenges 

Patent filings in the PFA field have surged in recent years. Applications cover innovations such as specialized electrode and catheter designs, pulse waveform parameters, pulse generators and integration with mapping systems.  

Despite the flurry of filings, securing robust patent protection for PFA technology can be tricky. One challenge highlighted above is that the underlying concept, using electrical pulses to ablate tissue, is not entirely new. Some of the earliest PFA-related filings in the cardiac space date back nearly 15 years and IRE has been used in other medical domains for over a decade, with basic electroporation techniques being described in literature well before that. Prior art outside of the cardiac space is often cited by Examiners alleging a lack of inventive step. Overcoming these objections requires demonstrating unexpected advantages or specific technical solutions, for example, unique electrode configurations that make PFA lesion creation more uniform, control algorithms for synchronization with the heartbeat or pulse sequences that preferentially affect the myocardium. 

Another hurdle, specifically in Europe, is the prohibition on patenting “methods of treatment” on the human body. Under Article 53(c) EPC, any claim that defines a method for treating a human (by surgery or therapy) is excluded from patentability. This means that while a U.S. patent might straightforwardly claim “a method of ablating cardiac tissue by delivering a pulsed electric field…”, an equivalent European patent has to be drafted in terms of a device or system, not the act of treatment. Typically, applicants claim a “catheter system configured to…” or a “pulse generator for use in cardiac ablation” to get protection in Europe that is functionally similar to a method. While medical use formats offer some flexibility, European patents tend to be narrower in this field, focusing on apparatus aspects, whereas U.S. patents can more freely cover the procedure and method steps. Companies filing globally might include multiple claim types to ensure strong protection in both jurisdictions. Collaboration between U.S. and European counsel is essential to navigate the differences.

Patent Enforcement and Litigation

Given the high stakes and multiple competitors, patent disputes are common in the cardiac ablation sector. The University of California’s 2017 infringement action against Boston Scientific, Abbott (St. Jude Medical), and AtriCure in 2017, over AF ablation catheter technology highlights how fiercely IP is defended in this sectorⁱⁱⁱ. As PFA technology matures, we can expect similar disputes to arise.

In Europe, patent disputes often play out through the opposition system at the EPO, giving an early chance to knock out a patent before it might be asserted in national court litigation. Any European patent, once granted, can be opposed by competitors within 9 months of grant, potentially leading to revocation or narrowing of the patent. The medical devices sector is no stranger to extensive patent opposition battles, and PFA will likely be no exception. The opposition process is a relatively cost-effective way to clear the path, compared to multi-jurisdiction court battles. For the patent owner, it means patents need to be robust to survive these early challenges. 

When it comes to litigation in courts, the landscape is different in the US vs Europe. A single US federal court decision can resolve infringement claims nationwide, while in Europe, enforcement traditionally required separate actions in each country. The recent introduction of the Unified Patent Court (UPC) significantly alters this landscape: patentees can now enforce a European patent across multiple countries (up to 18) with a single action. This is a game-changer for industries like medtech: a successful injunction could block a competitor’s PFA catheter across most of Europe with one court decision, rather than litigating country by country. Conversely, an accused infringer could seek to invalidate a rival’s patent on a pan-European basis via the UPC. The first year of the UPC has already sparked debate and strategy shifts among patent lawyers. For U.S. companies entering Europe, it means patent risk must be evaluated on a broader scale; the rewards of a strong patent are higher, but so are the risks if you infringe someone else’s patent. We have yet to see a PFA case in the UPC, but companies are surely positioning their European patent portfolios with this in mind.

Figure 1: Map of the UPC member states  

Finally, beyond patents, regulatory frameworks also shape the competitive landscape. Europe’s medical device regulatory regime unusually allowed use of some PFA devices in Europe before FDA approval in the US (e.g. Farapulse™ and Varipulse™ both adopted their CE mark in Europe before US launch). This early use in Europe can generate clinical data that can influence both patent filings and the assessment of prior art (e.g. prior use). 

The future of PFA innovation and IP

Pulsed Field Ablation is rapidly transforming the landscape of cardiac ablation, offering tangible benefits over traditional approaches. As leading medtech companies and innovative startups race to bring new PFA technologies to market, the competitive stakes are rising - not just in clinical adoption, but in the intellectual property arena as well.  Companies are needing to innovate continuously and navigate around each other’s IP through licensing or design-arounds.

Ultimately, those who combine technological leadership with savvy IP and legal strategy will be best placed to shape the future of AF treatment. As PFA adoption accelerates, we can expect the competitive, legal, and regulatory environments to continue evolving, making it essential for medtech firms to remain agile and well-advised as they seek to lead the next era of cardiac care.

1. https://www.tctmd.com/news/beat-parox-af-pulsed-field-ablation-not-superior-radiofrequency
2. https://www.escardio.org/The-ESC/Press-Office/Press-releases/Pulsed-field-ablation-was-not-superior-to-radiofrequency-ablation-in-paroxysmal-atrial-fibrillation
3. https://www.unifiedpatentcourt.org/en 

This blog was co-authored by Chloe Flower and Andrew Mears.