Boston Scientific enrolls first patient in FARADIGM IDE trial for Faraflex PFA system

A Boston Scientific (NYSE:BSX) executive said today that the company enrolled the first patients in a new pulsed field ablation (PFA) trial.

Nick Spadea-Anello, Boston Scientific EVP and president of Electrophysiology, shared the news of the initial enrollments on LinkedIn. Dr. Andrea Natale and the Texas Cardiac Arrhythmia Research team at St. David’s Medical Center performed the first procedure.

Boston Scientific’s 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. The company paired the 8 Fr NAV-enabled catheter with its Opal HDx mapping system. This could enable precise diagnostic mapping to understand arrhythmia mechanism and target ablations accordingly.

The technology builds upon the company’s Farapulse platform, its leading PFA offering that uses nonthermal electric fields to selectively ablate heart tissue.

Medical Design & Outsourcing: Nitinol Innovations Pulsed-Field Ablation Special Report

FARADIGM follows the ELEVATE-PF feasibility trial of Faraflex, which evaluated patients with paroxysmal or persistent AFib. Results shared earlier this year demonstrated pulmonary vein isolation durability of 96.4% at two months in the optimized group. That included 95.6% in patients with persistent AFib, specifically.

This study evaluates Faraflex with Opal HDx to evaluate the safety and efficacy of high-density mapping and PFA delivery in a single large focal device. Boston Scientific aims to help physicians better understand what areas of the heart to treat for more targeted, personalized care. The company said it could help to treat a wider range of patients with AFib.

Boston Scientific continues to push ahead as one of the leaders in the PFA space. However, questions have been growing around Farapulse and the company’s previous quarterly performance. More companies, such as Medtronic, Johnson & Johnson MedTech, Abbott and Kardium, are all gaining share.

On LinkedIn, Spadea-Anello wrote:

“I’m proud to share an important achievement for our Boston Scientific Farapulse pulsed field ablation portfolio — enrollment of the first patients in the FARADIGM global investigational device exemption (IDE) trial. This trial examines the safety and effectiveness of the Faraflex mapping and [PFA] catheter in patients with paroxysmal and persistent [AFib], a complex and increasingly prevalent disease impacting over 59 million people globally.”

Medical Design & Outsourcing: Get a first look at Boston Scientific’s next-gen Farawave Ultra PFA catheter