The pulsed field ablation is a nonthermal method that consumes less energy and offers target specificity, providing higher efficacy and safety during pulmonary vein isolation to treat atrial fibrillation. It uses electrical pulses to cause non thermal irreversible electroporation to induce cell death and treat irregular heartbeats using short bursts of electric energy. The ablation has been used to normalize the cardiac rhythm and help patients live a quality life to address the rising number of cases. However, the most distinguishing features of pulsed field ablation that cater to the attention of marketing drivers include point-to-point electrical impulse, minimal invasion, and atrial lesions that effectively reduce the chances of pulmonary vein reconnection.
Pulsed field ablation has been adopted to treat irregular heartbeat using short bursts of electric energy━thereby offering higher efficacy and does not damage adjacent cells or tissues. Driven by the above factors, several researchers are accelerating efforts to bring advances in pulsed field ablation technique to use it beyond atrial fibrillation. It is worth noting that with wide-scale adoption and higher efficacy of ablation, the pulsed field ablation market is expected to grow at a CAGR of 40% in the future.
Current Market Landscape of Pulsed Field Ablation
In recent years, there has been a demand for modern ablation technologies that offer minimal invasiveness and maximum efficacy in treating patients with atrial fibrillation. Pulsed field ablation emerged as a key technique to meet current treatment demand that uses high-voltage electrical pulses to deliver short bursts in the cell. The procedure significantly reduces the risk of discomfort and shortens the hospitalization time. Pulsed-field ablation has shown promising results in cardiac rhythm-associated disorders, including ventricular tachycardia and atrial fibrillation. Driven by the positive outcomes, the key market players have turned their attention towards pulsed field ablation technology. Some of the recently approved systems include; Affera™ Mapping and Ablation System (Medtronic), FARAPULSE™ Pulsed Field Ablation System (Boston Scientific), RheOx® system (Galvanize Therapeutics) and CENTAURI™ system (Galvanize Therapeutics). With ongoing research and rising interest in the development of non-invasive surgical treatments, it is anticipated that the market will grow exponentially in the future.
Key Pulsed Field Ablation Marker Drivers
Pulsed-field ablation has demonstrated positive outcomes in managing cardiac arrhythmias, particularly atrial fibrillation. PFA is a secure and precise substitute for traditional ablation methods as it effectively achieves pulmonary vein isolation and offers long-lasting isolation. Other potential key market drivers include;
▪ The rising number of cardiac arrhythmias, specifically atrial fibrillation, is growing steadily worldwide. At present, about 2.3 million people have been diagnosed with atrial fibrillation in the United States and expected to increase to around 5.6 million by 2050.
▪ Pulsed field ablation has been widely adopted to treat solid tumors by inducing inhibitory effects on the cancer cells and mobilizing immune systems to suppress invasion and tumor growth. In addition, pulsed field ablation has been used to treat chronic bronchitis by targeting the mucus-producing cells of bronchi.
Recent Advancements in Pulsed Field Ablation
It is worth highlighting that with the increasing occurrence of atrial fibrillation, scientists are paying attention to the higher efficacy and safety profile of ablation methodologies to overcome the risk of heart-sink effects. To achieve higher efficacy a, scientists are navigating advanced techniques, including:
▪ Irreversible Electroporation (IRE)
Irreversible electroporation refers to the non-thermal ablation technique that causes cell death without causing thermal damage to adjacent cells. It represents technological advancements in ablation procedures that offer better precision and minimal invasiveness. An example of an IRS system is NanoKnife® (AngioDynamics, Latham), an IRE-based ablation system. IRE helps achieve higher efficacy, so several researchers continue to explore its potential application beyond atrial fibrillation and cancer treatment.
▪ Nanosecond Pulsed Electric Field (nsPEFs)
Ablation with a nanosecond pulsed electric field is the best alternative to the radiofrequency ablation of atrial fibrillation. It is a non-thermal process that induces higher efficacy cell pores and reduces the ablation time. Nanosecond pulsed electric fields offer a significant advantage over traditional longer shock ablation methodologies. It ensures uniformity in electrophoresis, resulting in uniform cell pores. Earlier, the procedure was used to treat cancer by killing cancerous cells. After understanding the therapeutic effects, nsPEFs have been widely adopted to treat atrial fibrillation.
Top Pulsed Field Ablation Market Players
Examples of the pulsed field ablation market players who are actively engaged in the research and development process to produce advanced techniques for the treatment of cardiac problems include;
▪ AccuPulse Medical
▪ Acutus Medical
▪ Argá Medtech
▪ AtriAN Medical
▪ Aurigen Medical
▪ Biosense Website
▪ Boston Scientific
▪ ElectroPhysiology Frontiers
▪ EnChannel Medical
▪ Galvanize Therapeutics
▪ Hangzhou Dinova EP Technology
▪ Mirai Medical
▪ Pulse Biosciences
▪ Tianjin Intelligent Health Medical
Some Recent News and Developments of the PFA Ablation Market
Although the pulsed field ablation research mainly emphasized atrial fibrillation, market players have focused on applications beyond treatment. Some of the recent news and developments that have taken place to accelerate the research in the pulsed field ablation market include;
§ In July 2023, the 9th World Congress on Cardiology and Cardiovascular Therapeutics was held in Vancouver, Canada, highlighting modern techniques and therapeutic solutions to treat cardiovascular diseases.
§ In May 2023, Pulse Biosciences raised $65 million in a private placement round that Robert W. Duggan, the executive chairman at Pulse Biosciences, led. The funds raised in the round will be used to develop the company’s proprietary Nanosecond Pulsed Field ablation (nsPFA™) advancements for treating atrial fibrillation.
§ In March 2023, Medtronic received CE mark approval for the Affera™ Mapping and Ablation System to treat atrial fibrillation. The system also comprises Sphere-9™ Catheter and Affera™ Prism-1 Mapping Software.
The pulsed field ablation market has consequently developed within the past few decades. Several pulsed field ablation market players look forward to definitive clinical trials in the pipelines while sticking to the latest technologies and automation. By leveraging technology, companies will be able to address the challenges and develop an innovative approach for treating cardiac diseases and other chronic diseases with pulsed field ablation methods in the future.
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