Pulsed Field Ablation Market by Therapeutic Area, Product Components, Application Areas, Source of Ablation, and Key Geographical Regions: Market Share of Key Companies, Industry Trends and Global Forecasts, 2023-2035

Pulsed Field Ablation Market Overview

Pulsed field ablation market, a growing segment of the cardiac ablation market, is anticipated to grow at a compounded annual growth rate (CAGR) of ~40% during the forecast period 2023-2035. Over the years, medical researchers and practitioners have actively pursued the development of minimally invasive procedures that are less painful, have shorter recovery periods, and offer improved patient outcomes. Such techniques have been able to carve out a niche in the huge atrial fibrillation market. Traditional treatment methods involving surgical procedures, though effective, are accompanied with a wide range of drawbacks, including extensive scarring, longer hospital stays, and a higher risk of complications. As a result, medical experts have turned their attention to ablation therapies, which involve the use of an energy source to destroy the abnormal tissues in the body without the need for invasive surgeries. Currently, several tissue ablation techniques are being employed for the treatment of a wide range of disease indications. However, the conventional ablation methods often rely on thermal energy which can potentially lead to tissue overheating, leading to necrosis of the surrounding healthy tissue. Moreover, these techniques are associated with post-procedural pain and discomfort that impact the patient's quality of life during recovery. As the limitations of traditional ablation methods became apparent, the demand for safer and more effective alternatives led to the emergence of pulsed field ablation (PFA). 

Pulsed field ablation harnesses high-voltage electrical pulses delivered in short bursts. This non-thermal ablation process allows for precise targeting of abnormal tissues without causing collateral damage to surrounding healthy cells. By avoiding tissue overheating and charring, PFA ablation significantly reduces the risk of complications and post-procedural discomfort. Despite its applications across diverse medical specialties, pulsed field ablation has particularly shown significant promise in the treatment of cardiac rhythm-related disorders, including atrial fibrillation and ventricular tachycardia. Cardiac ablation through PFA involves the precise application of pulsed field electrical energy to create small scars in the cardiac tissue, effectively blocking irregular electrical signals and restoring a regular heartbeat. According to the Framingham Heart Study, over the past 50 years, the prevalence of atrial fibrillation has increased by three-fold. Owing to the rising disease burden of atrial fibrillation, as well as the ongoing research and development efforts to expand the applications of pulsed field ablation beyond cardiac ablation, the market is anticipated to witness remarkable market growth during the forecast period.

Key Market Insights

The Pulsed Field Ablation Market: Distribution by Therapeutic Area (Cardiovascular Disorders, Oncological Disorders, Respiratory Disorders and Dermatological Disorders), Product Components (Catheters and Generators), Application Areas (Ablation, and Ablation and Mapping), Source of Ablation (Pulsed Field Energy, Pulsed Field and Radiofrequency Energy, and Pulsed Field and Cryoablation Energy), Key Geographical Regions (North America, Europe and Asia-Pacific): Market Share of Key Companies, Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future opportunities associated with this industry, for the given forecast period. The market research report highlights the efforts of several stakeholders engaged in this emerging and rapidly evolving segment of the medical devices industry. Key takeaways of the pulsed field ablation market report are briefly discussed below.

Surging Prevalence of Atrial Fibrillation, a Key Indication for Pulsed Field Ablation

Atrial Fibrillation (AF) is the most commonly occurring sustained cardiac arrhythmia affecting both men and women, across the globe. Its prevalence tends to rise with age in the general population. Patients diagnosed with atrial fibrillation face a five-fold higher risk of stroke and a two-fold increased risk of death. According to the Global Burden of Disease, Injury and Risk Factor Study 2019, 59.7 million patients were afflicted with atrial fibrillation, globally. Since the elderly population is at higher risk of developing atrial fibrillation, the rising ageing world population poses a threat of surged AF prevalence. In the US, around 9% of the population aged 65 and above is suffering from atrial fibrillation. In Europe, atrial fibrillation has emerged as one of the key public health problems, with its prevalence doubling over the last decade. Owing to the rapidly growing ageing population in the European countries, a 70% increase in the number of atrial fibrillation patients has been projected, over the next decade. Further, improved detection and diagnosis of atrial fibrillation has contributed to the growing number of reported cases of this disorder. Moreover, there are multiple modern lifestyle-related risk factors that play a role in the rapidly increasing prevalence of atrial fibrillation. These risk factors include hypertension, diabetes mellitus, smoking, alcohol consumption, obesity, lack of physical activity and psychological stress. Atrial fibrillation (AF) has strong associations with other cardiovascular diseases, such as heart failure, coronary artery disease (CAD) and valvular heart disease. In order to treat the aforementioned cardiovascular disorders, several cardiovascular drug delivery devices / drug eluting stents are commercially available; however, the treatment options for atrial fibrillation, such as the anti-arrhythmic drugs (which form the first line of treatment), are often ineffective. Amongst the interventional treatments, pulsed field ablation, a non-thermal modality, is proving to be a safe procedure for atrial fibrillation patients.

Applications of Pulsed Field Ablation Technology for Cardiac Ablation

At present, several pulsed field ablation devices are available / being developed for therapeutic applications across cardiovascular disorders, oncological disorders, respiratory disorders, and dermatological disorders. In particular, pulsed field ablation devices have demonstrated high efficacy in treating and managing cardiac arrhythmias, while demonstrating selectivity for myocardial tissue and reducing the risk of esophageal injuries, pulmonary vein stenosis and phrenic nerve palsy. Amongst the various types of cardiac arrhythmias, PFA ablation is a proven modality for managing atrial fibrillation (persistent and paroxysmal), which is characterized by irregular beating of the atria (upper chambers) of the heart, due to which blood does not flow to the ventricles (lower chambers). The PFA ablation procedure primarily involves pulmonary vein isolation (PVI) procedure, which aims to restore normal heart rhythm by targeting and isolating the pulmonary veins, which are often the source of abnormal electrical signals that trigger atrial fibrillation. During the PVI procedure, catheters with electrodes are introduced into the heart through blood vessels. These catheters are guided to the pulmonary veins, and the electrodes deliver controlled electrical pulses to the tissue surrounding the pulmonary veins. The electrical pulses create lesions or scar tissue, which block the abnormal electrical signals from propagating to the rest of the atria. It is worth highlighting that beyond atrial fibrillation, the potential application of pulsed field ablation for the treatment of other cardiac arrythmias, including ventricular tachycardia and atrial flutter remains less explored.

Pulsed Field Ablation Transforming Treatment for Oncology and Other Indications

In the field of oncology, pulsed field ablation has been used for the treatment of a wide range of solid tumors, including malignant tumors. Application of electrical pulses can alter the tumor microenvironment, inducing an inhibitory effect on tumors by killing the tumor cells and mobilizing the immune system to suppress tumor growth and invasion. In addition, chronic bronchitis, characterized by inflammation of the airways, can be treated through PFA’s targeted ablation of the mucus producing cells lining the inner walls of bronchi. Pulsed field ablation has made significant strides in dermatology, providing an effective approach for precisely removing skin lesions, including both benign and pre-cancerous growths. The tissue selectivity of this type of ablative technology spares the non-cellular collagen foundation of the skin, allowing regeneration of target cells.

Advantages of Pulsed Field Ablation Over Thermal Ablation

Multiple beneficial attributes of pulsed field ablation technology render it a higher safety profile as compared to other thermal ablation techniques. One of the distinguishing features of pulsed field ablation is its tissue-selective functionality, making it particularly valuable in facilitating cardiac ablation procedures by mitigating risks of phrenic palsy and esophageal injury. Even while targeting the cardiomyocytes, this technique spares stromal proteins from alterations, thereby preventing unintended coagulative necrosis and ensuring a more precise and controlled tissue ablation. Further, the delivery of pulsed field energy, whether through one-shot or point-by-point ablation procedures, creates transmural and durable atrial lesions, which effectively reduces the occurrence of pulmonary vein reconnection. Depending on the specific medical condition and patient’s need, electrophysiologists can tailor the electroporation procedure by varying various electrical parameters, such as voltage, number of pulses, pulse width, pulse shape, pulse delay and frequency. It is important to note that pulsed field ablation utilizes apoptosis to induce cell death, leading to a non-inflammatory response and quicker post-procedure recovery time. 

Current Pulsed Field Ablation Market Landscape

The pulsed field ablation market features the presence of more than 45 pulsed field ablation devices. Of these, close to 90% of the devices comprise of ablation catheter as an intrinsic part of their product offering. Further, 39 pulsed field ablation devices are currently under various stages of development. In addition, the pulsed field ablation market features 35 companies that possess the necessary expertise to develop and commercialize pulsed field ablation devices. Currently, more than 40% of the pulsed field ablation companies engaged in this industry are small companies, with less than 50 employees. In terms of geographical presence, more than 50% of the pulsed field ablation companies are headquartered in North America. However, it is interesting to note that the majority of the pulsed field ablation devices have received regulatory approval in Europe.

Currently Commercialized Pulsed Field Ablation Devices

At present, seven pulsed field ablation devices have received commercialization approval from various regulatory bodies around the globe. Of these, four devices, namely FARAPULSE™ Pulsed Field Ablation System (Boston Scientific), Affera™ Mapping and Ablation System (Medtronic), RheOx® system (Galvanize Therapeutics) and CENTAURI™ system (Galvanize Therapeutics) are available in Europe. FARAPULSE™ was the first PFA ablation system to receive CE mark in EU to treat atrial fibrillation and remained the only such system till the approval of CENTAURI™ in August 2022. Further, Medtronic’s Affera™ is the latest pulsed field ablation catheter to receive CE mark in March 2023.

Further, two pulsed field ablation devices are approved in the US; these are Aliya™ system (Galvanize Therapeutics) for soft tissue ablation and CellFX System (Pulse Biosciences) for dermatological procedures. It is worth highlighting that NanoKnife System developed by AngioDynamics is the only pulsed field ablation device presently approved in China. 

Pulsed Field Ablation: Safety and Efficacy in Clinical Studies

More than 70% of the commercialized PFA ablation devices are undergoing clinical trials in regions where they have not yet received approval. The ADVENT pivotal trial, being conducted at 34 locations across US, aims to evaluate the effectiveness of FARAPULSE™ Pulsed Field Ablation by Boston Scientific for the treatment of paroxysmal atrial fibrillation. In addition, a pilot-scale clinical trial, SPACE AF, is being carried out in Canada to evaluate the safety and efficacy of the CENTAURI™ system. Further, Medtronic’s PulseSelect™ Pulsed Field Ablation System is currently being evaluated in PULSED AF, a multi-center, non-randomized, global clinical trial, to assess its effectiveness for the treatment of atrial fibrillation. The device exceeded its performance goal with negligible side effects, thus proving its efficacy. In fact, the clinical study evaluating PulseSelect™ Pulsed Field Ablation System reported a primary adverse events rate of 0.7%, one of the lowest amongst those recorded for any prior FDA Investigational Device Exemption (IDE) trial for atrial fibrillation ablation device. In addition, there were no reported events of esophageal injury, pulmonary vein stenosis or phrenic nerve damage. It is worth highlighting that three pulsed field ablation devices, namely FARAPULSE™ Pulsed Field Ablation System (Boston Scientific), PulseSelect™ Pulsed Field Ablation System (Medtronic) and RheOx® system (Galvanize Therapeutics) have received breakthrough designation from the FDA.

Pulsed Field Ablation Market: Cardiovascular Disorders Marget Segment to hold the Largest Market Share 

Given the increasing prevalence of atrial fibrillation, high efficacy and safety profile of ablation through irreversible electroporation, the pulsed field ablation market size is anticipated to grow at an annualized rate (CAGR) of nearly 40% during the forecast period 2023-2035. It is worth highlighting that, in terms of therapeutic area, cardiovascular disorders segment is expected to capture the majority market share in the pulsed field ablation market in 2023 and this trend is likely to remain unchanged throughout the forecast period.

Leading Pulsed Field Ablation Companies

Examples of key pulsed field ablation companies (device developers which have also been profiled in this market report) include (in alphabetical order) Abbott, AccuPulse Medical, Acutus Medical, AngioDynamics, Argá Medtech, AtriAN Medical, Aurigen Medical, Biosense Webster, Boston Scientific, CathRx, ElectroPhysiology Frontiers, EnChannel Medical, Galvanize Therapeutics, Hangzhou Dinova EP Technology, Kardium, Medtronic, Mirai Medical, Pulse Biosciences and Tianjin Intelligent Health Medical. This market report includes an easily searchable excel database of all the pulsed field ablation companies worldwide.

Recent Developments 

• Although the first direct current ablation was performed during the 1980s, the field gained momentum only after 2011, when PFA focused research to treat atrial fibrillation was initiated. Several developments have taken place in the field of pulsed field ablation, over the past few years. Some of these recent initiatives have been mentioned below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that we have been outlined in our analyses.
• In July 2023, the 9th World Congress on Cardiology and Cardiovascular Therapeutics was held in Vancouver, Canada.
• In May 2023, Pulse Biosciences raised an amount of USD 65 million in a private placement round. The round was led by Robert W. Duggan, executive chairman at Pulse Biosciences. The proceeds from the round will be utilized for the development of the company’s proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology for the treatment of atrial fibrillation.
• In March 2023, Medtronic received CE mark approval for the Affera™ Mapping and Ablation System for the treatment of atrial fibrillation. The system includes Sphere-9™ Catheter and Affera™ Prism-1 Mapping Software.

Scope of the Report

The market report presents an in-depth analysis of the various pulsed field ablation companies / organizations that are engaged in this industry, across different segments.

The market report presents an in-depth analysis, highlighting the capabilities of various pulsed field ablation companies, across different geographies. Amongst other elements, the market research report features:

• A preface providing an introduction to the full report, Pulsed Field Ablation Market, 2023-2035.
• An outline of the systematic research methodology adopted to conduct the study on pulsed field ablation market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
• An overview of economic factors that impact the overall pulsed field ablation market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the key insights captured during our research, offering a high-level view on the current state of the pulsed field ablation market and its likely evolution in the short to mid and long term.
• A general overview of pulsed field ablation, highlighting details on different types of ablation techniques. It also features details regarding various types of thermal and non-thermal ablation techniques. Further, it provides information on the various components of pulsed field ablation system, as well as its historical evolution, mechanism of action, therapeutic applications and advantages. 
• An overview of the current market landscape of pulsed field ablation devices based on relevant parameters, such as product components (ablation catheter, ablation generator, mapping software and others), shape of catheter (circular, linear, flower and basket, spherical and annular), configuration of catheter (open loop and closed loop), type of catheter (by irrigation) (irrigated, non-irrigated), catheter shaft diameter (less than 8 Fr, 8-10 Fr and more than 10 Fr), number of electrodes (less than 6, 6-10 and more than 10), electrical polarity (unipolar, bipolar, quadrapolar), source of ablation (PF, PF and RF energy, and PF and Cryoablation energy), status of development (commercialized and under development), application area (ablation only and ablation and mapping), and target therapeutic area (cardiovascular disorders, oncological disorders, respiratory disorders and dermatological disorders). Further, the chapter features landscape of pulsed field ablation device developers on the basis of relevant parameters, including year of establishment, company size (in terms of employee count), location of headquarters (North America, Europe and Asia-Pacific), type of developer (industry and non-industry) and company ownership (privately held and publicly listed).
• An insightful product competitiveness analysis of pulsed field ablation devices, based on player strength (based on years of experience, company size and number of devices offered), product competitiveness (based on application area, source of ablation, electrical polarity and special designation received) and status of development. 
• Elaborate profiles of prominent pulsed field ablation companies (shortlisted based on most advanced stage of development) engaged in offering PFA ablation devices. Each profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and key executives), details related to its financial performance (if available), product portfolio, recent developments and an informed future outlook.
• Tabulated profiles of key pulsed field ablation companies (shortlisted based on stage of development, for North America and Europe, the companies which have products in pilot stage clinical trial have been included, while for Asia-Pacific, companies for which information was available have been profiled) that are engaged in development of PFA ablation devices. Each tabulated profile features an overview of the company (including information on year of establishment, number of employees, location of headquarters and key executives) and information on its product portfolio.
• A detailed analysis of the recent developments and initiatives reported in pulsed field ablation market. The chapter features insightful analysis of the partnerships that have been inked within the global pulsed field ablation market since 2015, based on several relevant parameters such as year of partnership, type of partnership (mergers and acquisitions, product / technology integration agreement, product / technology utilization agreement, product development agreement, distribution agreement, clinical trial agreement, research agreement, service alliance), type of solution (PFA system, mapping system, integrated system, other systems), therapeutic area (cardiovascular disorders, oncological disorders and respiratory disorders), most active players (in terms of number of deals inked) and regional distribution of partnership activity. The chapter also features detailed analysis of funding and investments raised by pulsed field ablation companies, based on relevant parameters such as year of funding, type of funding, amount invested (USD Million), therapeutic area (cardiovascular disorders, oncological disorders and respiratory disorders), most active players (in terms of number of funding instances and amount raised), most active investors (in terms of number of funding instances) and regional distribution of funding.
• An insightful analysis of patents filed / granted for pulsed field ablation since 2009, taking into consideration various relevant parameters, such as type of patent, patent application year, patent publication year, geographical location, type of player, patent age, publication time, top CPC symbols, leading players (in terms of number of patents filed / granted). Further, the chapter includes a detailed patent benchmarking analysis.
• A detailed analysis of global events attended by the companies engaged in the pulsed field ablation industry, based on relevant parameters such as year of event, type of event, event platform, event organizer, location of event, most active players, speakers and designations (in terms of number of events).
• An in-depth analysis of cardiac mapping and navigation device developers, based on relevant parameters such as year of establishment, company size (in terms of number of employees) and location of headquarters. The chapter also features an analysis of the likelihood of partnership of cardiac mapping and navigation device developers with pulsed field ablation device developers. 
• An in-depth analysis of the factors that can impact the growth of pulsed field ablation market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.

The key objective of this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity for pulsed field ablation companies over the next decade. We have extensively studied the historical market data within this industry, in order to develop a deeper understanding of the evolutionary market trends. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period 2023-2035. The market report also features the likely distribution of the historical, current and forecasted opportunity within the pulsed field ablation market across various segments, such as therapeutic area (cardiovascular disorders, oncological disorders, respiratory disorders and dermatological disorders), product components (catheter and generator), application area (ablation, and ablation and mapping) and source of ablation (pulsed field energy, pulsed field and radiofrequency energy, and pulsed field and cryoablation energy) and geography (North America, Europe and Asia-Pacific). In addition, this report features the current and forecasted sales revenues of leading device developers engaged in this domain. In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s market growth. 

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is pulsed field ablation?

Answer: Pulsed field ablation is a non-thermal ablation modality that destabilizes cell membrane by forming irreversible pores, eventually leading to cell death. The current pulsed field ablation technology is an adaptation of direct current ablation, which was first used to treat cardiac arrhythmia in the 1980s.

Question 2: How does PFA ablation work?

Answer: Pulsed field ablation operates on the mechanism of irreversible electroporation. When pulsed electric fields are applied to a cell, its intracellular charged species get redistributed, disrupting the transmembrane potential. This leads to the formation of artificial nanopores, hindering the cell’s ability to maintain homeostasis. If the loss of homeostasis is of sufficient magnitude or duration, the cell cannot restore normal function and dies through either immediate necrosis or apoptosis.

Question 3: How is PFA performed?

Answer: Pulsed field ablation delivers short bursts of high amplitude electric current to kill abnormal tissues. In order to perform the ablation, a catheter is introduced into the human body, through a vein (femoral vein, for instance). Then the catheter is directed to the target organ (where ablation is to be performed) to ablate the abnormally functioning cells by creating transmural lesions.

Question 4: What are the benefits of pulsed field ablation?

Answer: Pulsed field ablation offers numerous benefits over conventional ablation techniques. These include: highHigh tissue-selectivity; Significantly less risk of collateral organ damage; Improved pulmonary vein isolation durability, thereby preventing recurrence of arrhythmia; Quicker post-procedure recovery; Reduced procedure duration; Lower contact dependency

Question 5: What is pulsed magnetic field radiofrequency ablation?

Answer: Pulsed magnetic field radiofrequency ablation is an innovative technology that delivers radiofrequency oscillations at a rate of pulses per second. Such devices offer greater flexibility to electrophysiologists by allowing them to toggle between energy sources, while performing the ablation procedure.

Question 6: When will pulsed field ablation be available?

Answer: Pulsed field ablation is currently available in Europe, with four commercialized devices in the market, of which three are approved for the treatment of atrial fibrillation, while one system is available for treating patients with chronic bronchitis. In the US, no pulsed field ablation device is commercially available for the treatment of atrial fibrillation. However, two PFA systems are approved for other indications in the US.

Question 7: What is the success rate of pulsed field ablation?

Answer: Several clinical studies have proven that the success rate of pulsed field ablation, in terms of freedom from recurrence of cardiac arrhythmias, is relatively higher than conventional ablation techniques. As per the recent results of the PULSED AF clinical trial conducted at 41 locations across the globe, pulsed field ablation device, PulseSelect™ Pulsed Field Ablation System, is associated with success rate of 80% for patients with paroxysmal atrial fibrillation and 81% for the persistent atrial fibrillation patients.

Question 8: Is FARAPULSE FDA approved?

Answer: In 2021, FARAPULSE™ Pulsed Field Ablation System received CE mark approval for commercialization in the European Union (EU). It was the first PFA device to receive market authorization for the treatment of atrial fibrillation. However, it has not yet received approval from the FDA.

Question 9: What is the estimated market growth rate (CAGR) for the pulsed field ablation market?

Answer: The pulsed field ablation market size is anticipated to grow at an annualized rate (CAGR) of nearly 40% during the forecast period 2023-2035.

Question 10: Who are the leading companies in the pulsed field ablation market?

Answer: Examples of key pulsed field ablation companies (device developers which have also been profiled in this market report) include (in alphabetical order) AccuPulse Medical, Acutus Medical, Adagio Medical, AngioDynamics, Argá Medtech, AtriAN Medical, Biosense Webster, Boston Scientific, CardioFocus, CathRx, CRC EP, Galvanize Therapeutics, Gradient Medical, Hangzhou Dinova EP Technology, Kardium, Medtronic, Mirai Medical, Pulse Biosciences and Tianjin Intelligent Health Medical.