Pulsed Field Ablation Companies Aiming for the Lucrative Atrial Fibrillation Market

Published: November 2023


Pulsed field ablation (PFA) represents a breakthrough, non-thermal ablation technology designed to treat abnormal electrical impulses in the heart. Unlike traditional methods such as radiofrequency or cryoablation, pulsed field ablation employs pulsed electric fields to target and eliminate faulty heart tissues responsible for erratic electrical signals. By precisely delivering electrical energy, pulsed field ablation aims to create scar tissue and interrupt the irregular electrical pathways, restoring the heart's rhythm. We analyzed more than 45 pulsed field ablation devices, developed by nearly 35 companies across the world which claim to possess the necessary technical expertise. In this article, we discover the leading pulsed field ablation companies.


Atrial fibrillation (AFib), a condition which is characterized by irregular heartbeats, affects millions worldwide. Over the years, the increasing prevalence of this disorder has fostered a competitive landscape among medical technology companies vying to offer innovative treatment options. In recent times, the emergence of pulsed field ablation has generated considerable excitement in the medical community as a promising treatment approach for AFib. Pulsed field ablation companies, sensing the potential of their technology in addressing the limitations of existing cardiac ablation procedures, are intensifying their efforts to gain a significant foothold in the dynamic atrial fibrillation market. Several prominent companies have spearheaded the development and commercialization of pulsed field ablation systems. To date, seven devices have already been approved in the market, across various geographies for the treatment of numerous disease indications; examples include (in chronological order of year of commercialization) Boston Scientific’s FARAPULSE Pulsed Field Ablation System (2021), Galvanize Therapeutics’ CENTAURI system (2022) and Medtronic’s Affera Mapping and Ablation System (2023). Notably, these three pulsed field ablation devices targeting cardiovascular disorders have successfully acquired the CE mark for European market access, yet none have secured approval from the FDA. 

Manufacturers continue to work on meeting the FDA's stringent criteria, aiming to bring these innovative and potentially transformative non-thermal ablation technologies to the US market. Further, in some recently published studies, the commercially available pulsed field ablation devices have demonstrated efficacy and safety comparable or superior to traditional methods, thereby significantly enhancing patient outcomes, and lowering recurrence rates. This growing body of real-world evidence highlighting the efficacy and safety of this cardiac ablation technique is likely to drive its adoption amongst healthcare practitioners. As several pulsed field ablation devices undergo clinical evaluation, the success of PFA ablation in shaping the AFib treatment landscape depends on robust clinical data, regulatory approvals, and widespread acceptance within the medical community.

Roots Analysis has conducted an exhaustive study on Pulsed Field Ablation Market, featuring the current market landscape and future opportunities for pulsed field ablation companies.

Table of Contents

Below, we have listed (in alphabetical order), the top 5 pulsed field ablation companies, shortlisted based on the basis of status of development of pulsed field ablation product(s) in their portfolio. These companies either possess a product on the market for the treatment of atrial fibrillation or are evaluating their product in pivotal clinical trial(s) for the same indication. It is essential to note that the selection of top players can differ substantially according to the defined criteria.

  1. Acutus Medical
  2. Affera
  3. Biosense Webster
  4. Boston Scientific
  5. Galvanize Therapeutics

Interested in exploring all 45+ commercialized / investigational solutions developed by pulsed field ablation companies across the world?

The section below provides details on the pulsed field ablation companies (listed above). Kindly note that detailed profiles of all the aforementioned companies, along with information on their financials, product portfolio and recent developments and future outlook, is available in the full report.

Positive Results from RECOVER AF Trial Encourage the Use of Integrated Ablation and Mapping Amongst Electrophysiologists Treating Complex Arrhythmias

Acutus Medical - Pulsed Field Ablation

Acutus Medical is a US-based company focused on providing guided ablation solutions for the management of cardiac arrhythmias. Leveraging its technical knowledge, the company has developed a range of products, including cardiac mapping system, transseptal access system and diagnostic catheters to deliver superior outcomes in patients suffering from cardiac arrythmias. It is worth highlighting that in August 2021, the AcQMap 8 software suite received CE Marking and FDA clearance. Additionally, the software introduced new mapping algorithms into Acutus’ AcQMap 3D imaging and mapping system.  Further, the company’s Acutus Pulsed Field Ablation system is currently under clinical evaluation for the treatment of atrial fibrillation.

Financial Insights:

In 2022, Acutus Medical aggregated total revenues worth USD 16.4 million, representing a decrease of 5% from the previous year’s performance (USD 17.3 million). Although there was a rise in the company’s disposables and other services sales of 12%, primarily driven by an increase in AcQMap procedures, the growth was offset with capital sales down USD 2.3 million compared to the previous year. Further, the company has reported revenues worth USD 4.2 million in Q1 2023, which represents an increase of 13%, compared to the revenues generated for the same time period in 2022.

Recent Developments:

  • In October 2023: Acutus Medical granted equity awards that were approved by the Compensation Committee of company’s Board of Directors. Similar grants have been approved every month since of beginning of 2023. This highlights the company’s focus on providing incentives or benefits to attracting new employees, encouraging specific business activities, or fostering particular developments in the organization.
  • July 2023: The company participated at the 43rd Annual Canaccord Growth Conference, which was held in Massachusetts, US. 
  • May 2023: The company presented its electrophysiology systems and technologies at the Heart Rhythm Society (HRS) Annual Scientific Sessions, which was held in Louisiana, US.
  • April 2023: The company reported the results from RECOVER AF Study. It was concluded that patients who had undergone pulmonary vein isolation (PVI) before enrollment achieved 91% freedom from AFib at one year, while the entire study population, with varying prior procedures, reported 76% freedom from AFib in the first year.

The table below provides details on the pulsed field ablation product(s) offered by the company.

Parameter Details
Product(s) Offered Acutus Pulsed Field Ablation System
Catheter Specific Details  AcQBlate Force Specifications:
  • Catheter Shape: Linear
  • Catheter Shaft Diameter: 8.5 Fr 
  • Number of Electrodes: 1
  • Catheter Configuration: Open loop
  • Electrical Polarity: Quadrapolar
Development Details The developmental / approval details of the products offered by the company are as follows:
Product Approval / Development Details in Europe:
In November 2021, the company initiated a clinical trial, with an aim to assess the safety and effectiveness of the Acutus Medical Pulsed Field Ablation System for the treatment of atrial fibrillation.

Further information related to Acutus Medical’s expertise in pulsed field ablation market and details on other pulsed field ablation companies are available in the full report.

 

Following the Success of inspIRE Pivotal Trial in Europe, Biosense Webster Gears Up to Become the Fourth Company to Secure CE Mark for a PFA Device

Biosense Webster - Pulsed Field Ablation

Biosense Webster, a subsidiary of Johnson & Johnson Medtech, is engaged in driving advancement in cardiac electrophysiology to improve the quality of care for arrhythmia patients worldwide. The firm’s product portfolio includes a wide range of diagnostic and therapeutic devices, including 3D navigation system, diagnostic catheters, therapeutic catheters and ultrasound solutions.  With multiple commercialized products, including  SMARTABLATE  System, THERMOCOOL RMT Catheter and NAVISTAR  Catheter, Biosense Webster has a well-established radiofrequency ablation portfolio. The company’s pulsed field ablation devices are currently under clinical evaluation for treating atrial fibrillation.

Recent Developments:

  • September 2023: Biosense Webster begins evaluation of its OMNYPULSE Pulsed Field Ablation (PFA) platform with integrated mapping, in Omny-IRE clinical trial in Europe. The principal components of this system are the OMNYPULSE Catheter and the TRUPULSE Generator.
  • February 2023: The company presented the positive results from the inspIRE clinical trial in the AF Symposium 2023, which was held in Massachusetts, US.

The table below provides details on the pulsed field ablation product(s) offered by the company.

Parameter Details
Product(s) Offered
  1. VARIPULSE Catheter and TRUPULSE Generator
  2. THERMOCOOL SMARTTOUCH SF Dual Energy Catheter
Catheter Specific Details 
  1. VARIPULSE Catheter Specifications:
    •  Catheter Shape: Circular
    • Catheter Shaft Diameter: 7.5 Fr
    • Number of Electrodes: 10
    • Catheter Configuration: Open loop
    • Electrical Polarity: Bipolar
    • Electrical Waveform: Biphasic
  2. THERMOCOOL SMARTTOUCH SF Dual Energy Catheter Specifications:
    • Catheter Shape: Linear
    • Catheter Shaft Diameter: 8 Fr
    • Catheter Configuration: Open loop
    • Electrical Polarity: Unipolar
    • Electrical Waveform: Biphasic
Development Details

The developmental / approval details of the products offered by the company are as follows:

  • Product Approval / Development Details in Europe:

In August 2021, the company announced data from the inspIRE clinical trial, which has been initiated to assess the safety and efficacy of the VARIPULSE Catheter and TRUPULSE Generator for treating symptomatic drug refractory recurrent paroxysmal atrial fibrillation.

In February 2023, the company initiated SmartfIRE clinical trial, to assess the safety and efficacy of THERMOCOOL SMARTTOUCH SF Dual Energy Catheter and TRUPULSE Generator for treatment of patients with atrial fibrillation.

  • Product Approval / Development Details in the US:

In April 2022, the company initiated AdmIRE clinical trial to evaluate the effectiveness of VARIPULSE Catheter and TRUPULSE Generator.

Further information related to Biosense Webster’s expertise in the pulsed field ablation market and details on other pulsed field ablation companies are available in the full report.


Foreseeing FARAPULSE as a “Transformational Electrophysiology Opportunity”, the Management Expects to Seek FDA Approval in 2024

Boston Scientific - Pulsed Field Ablation

Boston Scientific is a US-based firm that offers minimally invasive medical devices intended for the diagnosis and treatment of numerous disease indications. The company’s operations span across a wide range of specialties, including endoscopy, neuromodulation, interventional cardiology, peripheral interventions, rhythm management, pelvic health, and urology. The firm’s electrophysiology business segment is focused on the treatment of various types of heart rhythm disorders, offering interventional electrophysiology products such as defibrillators, pacemakers, imaging catheters and ablation catheters.  In June 2021, the firm completed the acquisition of FARAPULSE, in order to strengthen its electrophysiology portfolio. It is worth highlighting that FARAPULSE Pulsed Field Ablation (PFA) system was the first cardiac PFA technology to get commercialized in Europe, after receiving the CE Mark in January 2021 for the treatment of paroxysmal atrial fibrillation.  In the last two years, FARAPULSE  has enabled the treatment of more than 25,000 patients in Europe and Asia. According to Joe Fitzgerald (President of Boston Scientific’s Cardiology Business), the positive results from its recent AVDENT trial highlight the prospective FDA approval of FARAPULSE in 2024.

Recent Developments:

  • August 2023: The company announced positive 12-month results from the pivotal ADVENT clinical trial of the FARAPULSE Pulsed Field Ablation (PFA) System.
  • May 2023: Boston Scientific presented real-world outcomes from the EU-PORIA registry of the FARAPULSE Pulsed Field Ablation (PFA) System at the Heart Rhythm 2023, which was held in Louisiana, US.

The table below provides details on the pulsed field ablation product(s) offered by the company.

Parameter Details
Product(s) Offered
  1. FARAPULSE Pulsed Field Ablation System
  2. FARAPOINT Catheter
  3. FARAFLEX Catheter
  4. FARAONE Catheter
Catheter Specific Details 
  1. FARAWAVE Pulsed Field Ablation Catheter Specifications:
    • Catheter Shape: Flower and basket
    • Catheter Shaft Diameter: 12.8 Fr
    • Number of Electrodes: 20
    • Catheter Configuration: Closed loop
    • Electrical Polarity: Bipolar
    • Electrical Waveform: Biphasic
  2. FARAPOINT Catheter Specifications:
    • Catheter Shape: Linear
    • Catheter Configuration: Open loop
  3. FARAFLEX Catheter Specifications:
    • Catheter Shape: Flower and basket
    • Catheter Shaft Diameter: 12 Fr
    • Number of Electrodes: 16
    • Catheter Configuration: Closed loop
    • Electrical Polarity: Bipolar
  4. FARAONE Catheter Specifications:
    • Catheter Shape: Circular
    • Catheter Configuration: Closed loop

Development Details
The developmental / approval details of the products offered by the company are as follows:
  • Product Approval Details in Europe:
In January 2021, the company received CE mark for its FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation. The approval was based on clinical results which indicated that electric fields, the key ablation modality in FARAPULSE, are effective in suppressing abnormal heart signals, while reducing the risk of collateral organ damage. More than 170 patients were enrolled in the European feasibility studies of the FARAPULSE PFA system.
  • Development Status in the US:
In May 2019, the firm received FDA Breakthrough Designation for the FARAPULSE Pulsed Field Ablation system. Further, in March 2021, the company initiated its ADVENT pivotal trial in the US, enrolling close to 900 patients. It is a randomized control and pivotal trial to compare pulmonary vein isolation using Pulsed Field Ablation with the conventional thermal ablation procedures (Radiofrequency Ablation and Cryoballoon Ablation). The procedures will be conducted by more than 50 leading electrophysiologists across the US. The primary endpoint of the study is to achieve acute procedural success and freedom from atrial fibrillation, after 3 months of the ablation procedure.

Further information related to Boston Scientific’s expertise in the pulsed field ablation market and details on other pulsed field ablation companies are available in the full report.


Medtronic Eyes the Uncontested Pulsed Field Ablation Market in the US Following Positive Clinical Results from its PULSED AF Trial

Medtronic - Pulsed Field Ablation

Medtronic is a US-based firm that is focused on developing innovative diagnostic and therapeutic solutions for more than 70 disease indications. The company operates through four business segments (based on therapeutic area), namely cardiovascular, diabetes, medical surgery, and neuroscience. The Cardiac Rhythm and Heart Failure division, which is a part of the company’s cardiovascular portfolio, operates through three divisions, namely Cardiac Rhythm Management; Cardiac Ablation Solutions; and Cardiovascular Diagnostics and Services. The firm leverages its 40 years of experience in manufacturing energy-based medical devices, to offer cutting-edge ablation technologies in order to support patient safety, clinical efficacy and procedural efficiency.  In August 2022, the firm completed the acquisition of Affera, in order to expand its cardiac ablation portfolio.  Through the acquisition, the company added Affera Prism-1 cardiac mapping and navigation platform and Sphere-9 cardiac diagnostic and ablation catheter to its portfolio. In March 2023, the firm received CE Mark for the Affera Mapping and Ablation System intended for the treatment of atrial arrhythmias.  Additionally, the company’s PulseSelect Pulsed Field Ablation System is being evaluated through a multicenter clinical study.  According to multiple sources, Medtronic is on track to have the first pulsed field ablation catheter approved in the US, after  success in the pivotal trial of its PulseSelect device.

Financial Insights:
In 2023, Medtronic reported total revenues worth USD 31.2 billion, representing a decrease of 1.3% from the previous year’s performance (USD 31.6 billion).  However, the company reported an increase of 5.6% in its revenue, during the fourth quarter of FY 2023. Further, the firm’s cardiovascular portfolio generated a revenue of USD 11.6 billion in 2023, contributing 37% to the net revenue generated in the same year.

Recent Developments:

  • May 2023: The company presented the results of  PULSED AF. The study concluded that 87% of paroxysmal (PAF) and 82% of persistent (PsAF) AFib patients experienced less than 10% of atrial arrhythmia burden, after treatment with Medtronic’s PulseSelect Pulsed Field Ablation (PFA) System.
  • April 2023: The company participated in the ACC 2023 Meeting, which was held in Louisiana, US

The table below provides details on the pulsed field ablation product(s) offered by the company.

Parameter Details
Product(s) Offered
  1. Affera Mapping and Ablation System
  2. PulseSelect Pulsed Field Ablation System
Catheter Specific Details 
  1. Sphere-9 Catheter Specifications:
    • Catheter Shape: Spherical
    • Catheter Shaft Diameter: 7.5 Fr
    • Number of Electrodes: 9
    • Catheter Configuration: Closed loop
    • Electrical Polarity: Bipolar
    • Electrical Waveform: Biphasic
  2. PulseSelect Catheter Specifications:
    • Catheter Shape: Circular
    • Catheter Shaft Diameter: 9 Fr
    • Number of Electrodes: 9
    • Catheter Configuration: Open loop
    • Electrical Polarity: Bipolar
    • Electrical Waveform: Biphasic
Development Details The developmental / approval details of the products offered by the company are as follows:
  • Product Approval Details in Europe:
In March 2023, the company received CE mark for its Affera Mapping and Ablation System for the treatment of atrial arrhythmias. The approval was based on clinical results assessing the safety and efficacy of Sphere-9 catheter and mapping system.
  • Development Status in the US:

In December 2021, the firm initiated a multi-center SPHERE Per-AF clinical trial to evaluate the clinical efficiency of the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System. Further, in December 2022, the enrollment for the trial was completed in the US, which included more than 475 patients. It is a randomized control and pivotal trial to study mapping and ablation treatment for atrial fibrillation.

In December 2019, the company initiated PULSED AF clinical trial, a multi-center, non-randomized, worldwide study. The purpose of the study was to demonstrate the safety and efficacy of PulseSelect Pulsed Field Ablation System for the treatment of atrial fibrillation. In March 2023, the company announced that the PulseSelect PFA System exceeded its goal for safety performance, with 0.7% adverse event rate. Further, no esophageal, phrenic nerve injury was recorded.

Further information related to Medtronic’s expertise in pulsed field ablation market and details on other pulsed field ablation companies are available in the full report.


Galvanize Therapeutics Leverages its Core Aliya PEF Technology to Develop Diverse Pulsed Field Ablation Solutions Across Three Therapeutic Areas

Galvanize Therapeutics - Pulsed Field Ablation

Galvanize Therapeutics is a US-based company that claims to be a global leader in the energy-based medical device technology industry. The firm is focused on developing pulsed field ablation systems across several therapeutic areas, including cardiovascular disorders, oncological disorders and respiratory disorders, to produce long-lasting therapeutic outcomes in diverse patient population.  In September 2022, Galvanize Therapeutics merged with Gala Therapeutics and Galaxy Medical to form one company under the name of Galvanize Therapeutics. The company has achieved significant milestones in regulatory clearances. In September 2022, the firm received FDA regulatory clearance for its Aliya System, a pulsed field system designed for the treatment of  ablation of soft tissues  Furthermore, the company received the CE Mark for another pulsed field ablation system, CENTAURI Pulsed Electric Field (PEF) System used in the treatment of  paroxysmal atrial fibrillation, in August 2022.  Additionally, in September 2019, the company received CE Mark for RheOx system, for the treatment of chronic bronchitis patients. According to Jonathan Waldstreicher, CEO of Galaxy Medical, CENTAURI system is the workhorse PEF system for all electrophysiology labs, enabling physicians to maintain use of their favored mapping systems and catheter.

The table below provides details on the pulsed field ablation product(s) offered by the company.

Parameter Details
Product(s) Offered
  1. CENTAURI System
  2. RheOx System
  3. Aliya System
The following sections present details only on the CENTAURI system which is designed to treat arial fibrillation.
Development Details In September 2021, the company initiated a single-arm clinical study to evaluate the performance of CENTAURI system for atrial fibrillation ablation.

Further information related to Galvanize Therapeutic’s expertise in the pulsed field ablation market and details on other pulsed field ablation companies are available in the full report.

What About the Other Pulsed Field Ablation Companies?

The above presentation features five promising pulsed field ablation companies selected from a pool of nearly 35 firms that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.
 

About Author

Jasparam Kaur

Jasparam Kaur, a senior business analyst, has been a pivotal member of the Roots Analysis team since 2020.  She has consistently showcased her expertise in crafting insightful and top-notch quality market research reports across various niche and mature segments within the healthcare industry. Her analytical skills are truly adept, and her unwavering attention to detail is her hallmark. Beyond her work on syndicate market research reports, Jasparam has successfully undertaken various challenging consulting projects for esteemed firms. Her involvement spans from shaping project proposals to defining precise project requirements, devising rigorous methodologies, and ultimately, finding solutions to complex business challenges. During her journey at Roots Analysis, she honed a diverse range of technical skills in data analysis. Her expertise encompasses areas such as forecasting and opportunity assessment, competitive analysis and a variety of other quantitative, qualitative and strategic frameworks tailored to deliver valuable insights for the drugs, medical devices, and service-based markets.
 

Source1: https://www.acutusmedical.com/us/media-news/
Source2: https://www.jnjmedtech.com/en-US/company/biosense-webster/news
Source3: https://news.bostonscientific.com/news-releases
Source4: https://news.medtronic.com/2023-03-06-Medtronic-PulseSelect-PFA-System-demonstrates-impressive-results-in-landmark-PULSED-AF-global-IDE-trial
Source5: https://galvanizetx.com/news/

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