Forget Stent Wars: PFA Emerges as the Next Competitive Frontier in Medical Devices
At a Glance
- The Farawave Nav Ablation Catheter integrates cardiac mapping and therapy delivery.
- The Farawave Nav system reduces the need for multiple devices during procedures.
- Experts anticipate significant growth in the PFA market, comparing it to the historical competition seen in the stent market.
The pulsed-field ablation (PFA) market is fierce. However, Boston Scientific hopes to gain an advantage with the new Farawave Nav Ablation Catheter.
The Marlborough, MA-based company announced it won a nod from FDA for the device that enables cardiac mapping and PFA. FDA also cleared software called Faraview, which will provide visualization with Farapulse procedures.
The device treats paroxysmal atrial fibrillation.
The company initially received FDA approval for the Farapulse PFA in late January. Boston Scientific inherited the technology when it acquired Farapulse in 2021.
The Farawave Nav Ablation Catheter stands out from other FDA-approved solutions because physicians often use a separate mapping catheter prior to a cardiac PFA procedure to examine and analyze the heart’s electrical patterns and plan the therapeutic applications for each patient.
The Farawave Nav Ablation Catheter builds upon the current Farawave catheter by adding magnetic navigation capabilities, enabling cardiac mapping and PFA therapy delivery within a single integrated catheter, while minimizing the need for additional device exchanges.
“The addition of the Farawave Nav Ablation Catheter and Faraview Software to our portfolio provides a next-level pulsed field ablation mapping experience with cost-effective tools developed specifically and uniquely for the Farapulse PFA System,” said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. “Built on this safe and clinically-proven platform – which has been used to treat more than 125,000 patients globally – the visualization capabilities offered by these new technologies are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures.”
The PFA Playing Field
The PFA market took off in the US when Medtronic won FDA approval for the PulseSelect PFA, late last year. PulseSelect’s approval came about one month after the device won CE mark.
Johnson & Johnson is another huge player in the market. The New Brunswick, NJ-based firm is developing the Varipulse PFA catheter. Late last month, Johnson & Johnson unveiled data from Varipulse’s pivotal study.
Results showed the rate of freedom from atrial arrhythmias through one year was about 75%. Johnson & Johnson, which is still vying for FDA approval, also has a cardiac-mapping component for Varipulse.
During a recent media briefing discussing the Pulse of the Medtech Industry Report, John Babitt, Life Sciences Partner at EY, spoke about the potential growth of the PFA market.
“The whole field of PFA is a massive growth market for medtech and one where over the next three years will be a real active space,” Babitt told MD+DI during the media briefing held earlier this month. “It literally could be the next episode of the stent wars, if you go way back in time.”
Author：Omar Ford.
