Farawave single-shot catheter, apart of the Farapulse PFA system.
Pulsed Field Ablation (PFA) is a promising new technology in the medical field, and its popularity is on the rise. PFA uses controlled, pulsed electric fields to disrupt irregular electrical pathways in the heart that cause conditions like atrial fibrillation (AF). This innovative approach is expected to offer a safer and more effective alternative to traditional ablation methods, and is quickly gaining recognition as a potential game-changer in the field of electrophysiology. Its increasing popularity is also reflected in the growing number of clinical trials and studies exploring its potential benefits and effectiveness.
Recently, Biosense Webster, a subsidiary of Johnson & Johnson, has reported favorable results from its clinical trials for Pulsed Field Ablation (PFA) devices. These results reinforce confidence in the potential of PFA technology. In this blog, we will delve deeper into the subject and examine other companies that also have plans to enter the PFA market.
Biosense Webster: VARIPULSE™ and TRUPULSE™
In 2020, Biosense Webster took a major step in the development of its Pulsed Field Ablation (PFA) technology with the launch of its European inspIRE clinical trial. The study aimed to assess the safety and effectiveness of the company’s VARIPULSE™ Catheter and TRUPULSE™ Generator in treating symptomatic, drug-resistant recurrent paroxysmal atrial fibrillation (AF).
Fast forward to 2023, at the AF Symposium, Biosense Webster announced the exciting results of the inspIRE clinical trial. The trial met both its primary safety and efficacy endpoints, showcasing the success of PFA technology in treating AF (Duytschaever et al., 2023). This achievement is a significant milestone in the development of PFA and brings hope to patients suffering from AF.
Additionally, Biosense Webster began enrolling the first participants in its admIRE clinical trial in the United States in April 2022. This US study aims to assess the safety and efficacy of the company’s Pulsed Field Ablation (PFA) Platform, consisting of the VARIPULSE™ Catheter and the TRUPULSE™ Generator, in treating drug-resistant symptomatic paroxysmal atrial fibrillation (PAF). Over 400 patients in the US will be included in the non-randomized, prospective, multi-center study, which will evaluate the PFA platform during standard electrophysiology mapping and ablation procedures and measure primary adverse events occurring within seven days post-procedure.
Medtronic and Boston Scientific: Trials Underway
Biosense Webster is not alone in exploring the potential of Pulsed Field Ablation (PFA) technology. Other companies like Medtronic and Boston Scientific are also conducting, or have already conducted, their own trials.
In March 2021, Medtronic made headlines with the announcement of the first procedures in its investigational device exemption (IDE) trial for the PulseSelect™ Pulsed Field Ablation System. According to Medtronic, the PulseSelect System uses pulsed electric fields to target irregular electrical pathways in the heart that cause AF. The company’s PULSED AF trial boasts a significant enrollment of 500 patients across 50 sites in the US, Canada, Europe, and Australia. This trial further highlights the increasing interest and investment in PFA technology as a potential solution for AF.
On the other hand, Boston Scientific already has a PFA system on the market. Three key elements of the FARAPULSE PFA System are: the FARADRIVE™ Steerable Sheath for access and navigation, the FARAWAVE™ PFA Catheter for treating PV (Pulmonary Vein) anatomies with its over-the-wire catheter with multiple distal shapes (basket and flower), and the FARASTAR™ PFA Generator that uses a simple three-button system for preparing, confirming, and delivering therapy in a bipolar and biphasic waveforms with unique pulses (3).
In Summary
In conclusion, Pulsed Field Ablation (PFA) is a promising new technology in the medical field that is quickly gaining recognition as a game-changer in the treatment of conditions like atrial fibrillation (AF). With companies like Biosense Webster, Medtronic, and Boston Scientific leading the way in the development of PFA technology, it is exciting to see the results of their clinical trials and the growing number of studies exploring its potential benefits. The results of the inspIRE clinical trial conducted by Biosense Webster have reinforced confidence in the potential of PFA technology, and the launch of the admIRE clinical trial in the US is another significant milestone. As more companies invest in PFA technology, it is likely that we will continue to see its impact and potential for treating AF and other medical conditions.
References:
- Bradley, C. J., & Haines, D. E. (2020). Pulsed field ablation for pulmonary vein isolation in the treatment of atrial fibrillation. Journal of Cardiovascular Electrophysiology, 31(8), 2136–2147. https://doi.org/10.1111/jce.14414
- Duytschaever, M., De Potter, T., Grimaldi, M., Anic, A., Vijgen, J., Neuzil, P., Van Herendael, H., Verma, A., Skanes, A., Scherr, D., Pürerfellner, H., Rackauskas, G., Jaïs, P., & Reddy, V. Y. (2023). Paroxysmal af ablation using a novel variable-loop biphasic pulsed field ablation catheter integrated with a 3D mapping system: 1-year outcomes of the Multicenter Inspire Study. Circulation: Arrhythmia and Electrophysiology. https://doi.org/10.1161/circep.122.011780
- Farapulse – pulsed field ablation system. www.bostonscientific.com. (n.d.). Retrieved February 9, 2023, from https://www.bostonscientific.com/en-EU/products/catheters-ablation/farapulse.html
- First patients in the U.S. enrolled in Biosense Webster Clinical Study … (n.d.). Retrieved February 8, 2023, from https://www.jnjmedtech.com/en-US/news-events/first-patients-us-enrolled-biosense-webster-clinical-study-evaluate-varipulse
- Malpass, E. (2023, February 6). “early success” seen in late-breaking data evaluating “innovative” new treatments for AF. Cardiac Rhythm News. Retrieved February 8, 2023, from https://cardiacrhythmnews.com/early-success-seen-in-late-breaking-data-evaluating-innovative-new-treatments-for-af/
- Medtronic announces first procedures in pivotal trial to evaluate novel ablation technology in treating atrial fibrillation. Medtronic News. (n.d.). Retrieved February 8, 2023, from https://news.medtronic.com/2021-03-04-Medtronic-Announces-First-Procedures-in-Pivotal-Trial-to-Evaluate-Novel-Ablation-Technology-in-Treating-Atrial-Fibrillation
