This latest technology marks another milestone for the Farapulse PFA portfolio. Boston Scientific initially won FDA approval for Farapulse in January 2024 and has since reported a number of significant developments, most recently earning CE mark for new mapping technology last week.
Dr. Ante Anic performed the cases, observed by Dr. Oussama Wazni and Dr. Walid Saliba. They took place at KBC Split in Split, Croatia, as part of the premarket ELEVATE-PF feasibility study.
Faraflex, an investigational catheter system, is designed to optimize mapping and ablation in a single catheter with a wide-area tip and high-fidelity sensing electrodes. Boston Scientific plans to integrate the 8 Fr NAV-enabled catheter into its Opal HDx mapping system. This could enable precise diagnostic mapping to understand arrhythmia mechanism and target ablations accordingly.
Boston Scientific’s Cardiology page on LinkedIn posted a case video visualizing the use of Fieldtag technology PFA markers to plan, execute and confirm PFA delivery via the Faraflex catheter.
The company’s AFib Solutions Chief Medical Officer Dr. Brad Sutton posted that the cases took place last week. Sutton said this adds to Boston Scientific’s “robust clinical evidence” for Farapulse.
“This innovation exemplifies the Boston Scientific patient-first mindset, high performance, and global collaboration,” Sutton wrote.
Nick Spadea-Anello, the company’s president of Electrophysiology, said this latest milestone makes it four Farapulse catheters now in clinical research. He said research continues at multiple European centers to evaluate Faraflex’s safety and effectiveness in persistent AFib.
“This is a significant milestone in our efforts to treat more patients with [AFib] around the world,” he wrote.
Additional quote from Boston Scientific AFib Solutions Chief Medical Officer Dr. Brad Sutton
In a statement emailed to MassDevice from a spokesperson on behalf of Boston Scientific, Sutton said:
“The first case uses of the Faraflex mapping and PFA catheter is a significant milestone for the Farapulse PFA system. The Faraflex catheter, a built-for-PFA large focal ablation catheter, integrates seamlessly with the OPAL HDx mapping system, providing precise diagnostic mapping to understand arrhythmia mechanism and target ablations accordingly. This study will add to the robust clinical evidence of the Farapulse PFA system, the most clinically studied PFA system in the world, and marks a significant step forward in our ongoing innovation and commitment to advancing cardiac care.”
Read more from Sutton about Faraflex in an interview at Medical Design & Outsourcing.
