First Look: Boston Scientific’s next-gen Faraflex PFA and mapping catheter

Boston Scientific recently announced the first-in-human procedures using its next-generation Faraflex pulsed field ablation (PFA) and mapping catheter.

The investigational catheter was built specifically for PFA and mapping, said Dr. Brad Sutton, the chief medical officer of Boston Scientific’s Atrial Solutions Business, which includes PFA systems for treating atrial fibrillation (Afib).

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.”

At 8 Fr, Faraflex is smaller than Boston Scientific’s 12 Fr Farawave PFA catheter, which the FDA approved with the Farapulse PFA system for treating Afib in January 2024 shortly after Medtronic won the first-of-its-kind FDA approval.

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

Sutton described the expandable catheter as a flexible lattice with a pre-specified, nonadjustable shape, 19 sensing electrodes and a next-gen handling system.

“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.”

“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 then anything outside the atrium — the ventricle is its own complex animal and ventricular tachycardia ablation, I think we’re very much on the front end of that journey with PFA, but it’s really promising,” he later continued. “What Faraflex represents is a bit more precision and a much higher fidelity mapping capability to understand the heart tissue itself, how much is scar, what is healthy, and what is the electrical framework and structure and functionality of that chamber of the heart.”

Dr. Ante Anic performed the first-in-human procedures in Croatia, observed by Cleveland Clinic Drs. Oussama Wazni and Walid Saliba.

Those first cases “went as well as we could have possibly hoped for,” Sutton said, characterizing their feedback on the catheter as an “easy to use, utilitarian sort of tool for anything complex [that] stacks up very favorably to anything they’ve used from the competition.”

Sutton said he hopes to launch an investigational device exemption (IDE) trial in the second half of 2025 or early 2026.

“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.

Boston Scientific is scheduled to offer more details on April 26 at the Heart Rhythm Society’s annual meeting in San Diego.