Boston Scientific’s Faraflex pulsed-field ablation (PFA) and mapping catheter [Image courtesy of Boston Scientific]
The investigational catheter was built specifically for PFA and mapping, said Dr. Brad Sutton, the chief medical officer of Boston Scientific’s AF Solutions Business, which includes PFA systems for treating atrial fibrillation (AFib or AF).
In an interview with Medical Design & Outsourcing, Sutton described Faraflex as “a pretty nice blend” of Boston Scientific’s high-density mapping catheter technology — he noted the Intellamap Orion mapping catheter in particular — with “what we think the market needs and patients need moving forward in the PFA world.”
Boston Scientific’s Intellamap Orion mapping catheter [Image courtesy of Boston Scientific]
Farawave is a single-shot catheter, while Faraflex is a large focal catheter. Boston Scientific said Faraflex is “designed to optimize mapping and ablation in a single catheter with a wide-area tip and high-fidelity sensing electrodes.”
Faraflex is a navigation-enabled catheter and “will be integrated into the OPAL HDx Mapping System enabling precise diagnostic mapping to understand arrhythmia mechanism and target ablations accordingly,” the company said. (Boston Scientific added magnetic navigation capabilities to its Farawave catheter and won FDA approval for that upgrade in October 2024).
Previously: Catheter design was key for the Boston Scientific Farapulse pulsed-field ablation system
Boston Scientific’s FDA-approved Farapulse PFA and mapping system includes the Farawave catheter, which can take the shape of a flower or a basket. [Image courtesy of Boston Scientific]
“We expect it to be atraumatic and easy to navigate to all the nooks and crannies you might expect in the chambers of the heart,” he said. “There was a prototype, sort of first-generation Faraflex that the Farapulse company had developed. They toyed around with it a little bit for atrial flutter on the right side of the heart. It was a catheter that really wasn’t commercially viable, so this is using the same concept but a much more sophisticated design.”
Previously: Pulsed-field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J MedTech
Pulmonary vein isolation and posterior wall isolation can handle most de novo paroxysmal and persistent AFib cases.
“That’s a huge chunk of the market,” Sutton said. “It’s a very easy workflow. It’s not the most intellectually sophisticated, stimulating thing to do because it’s all anatomical, and electrophysiologists love to do more complex ablations. Frankly, there’s a clinical need to do more complex ablations, and single-shot tools aren’t the best set of tools for that. The unmet need [for] Faraflex is what if you have a redo patient with a complex atrial arrhythmia and you really need to understand both the electrical substrate, potentially the mechanism of the arrhythmia, where is it coming from, what is the electrical circuit — how do I tackle it? And anything outside the atrium — the ventricle is its own complex animal, and [with] ventricular tachycardia ablation, we’re very much on the front end of that journey with PFA, but it’s really promising.”
Boston Scientific’s Faraflex pulsed field ablation (PFA) and mapping catheter has 19 sensing electrodes on the self-expanding, hexaspline nitinol structure. [Image courtesy of Boston Scientific]
Dr. Ante Anic performed the first-in-human procedures in Croatia, observed by Cleveland Clinic Drs. Oussama Wazni and Walid Saliba.
This screenshot from Boston Scientific’s OPAL HDx mapping system shows the investigational Faraflex PFA ablation and mapping catheter at work. [Image courtesy of Boston Scientific]
Boston Scientific AF Solutions Chief Medical Officer Dr. Brad Sutton [Photo courtesy of Boston Scientific]
“Right now, we’re having conversations around the IDE design, leadership of the global study, what that looks like, and looking to understand exactly what the regulatory path is going to be,” he said.
More from Brad Sutton: PFA safety and Boston Scientific’s PFA advantage
