The regulatory nod, earned last week, allows the Marlborough, Massachusetts-based company to bring the newest PFA catheter in its electrophysiology portfolio to the European market. Farapoint treats right atrial flutter (AFL), ablating the cavotricuspid isthmus (CTI) area of the heart.
Boston Scientific says CE mark represents a new cardiac arrhythmia indication for its Farapulse PFA platform, now extending to AFL. Farapulse, a PFA system originally developed to treat AFib, received a much-anticipated FDA approval for that indication last year.
“Pulsed field ablation is already proven to deliver more effective ablation procedures for the treatment of atrial fibrillation, compared with standard radiofrequency ablation and cryoablation treatments,” said Andrea Natale, professor of medicine, Cardiology Division, University of Rome Tor Vergata, Italy. “We are now seeing the promise of PFA in treating atrial flutter, and the Farapoint PFA catheter, along with wider mapping and 3D visualization abilities of the Farapulse PFA platform, can offer physicians the ability to optimise workflows and tailor atrial flutter procedures.”
Analysts recently said that Boston Scientific aims to become the top player in the electrophysiology space with its Farapulse platform. It currently battles Medtronic and Johnson & Johnson MedTech in the PFA market, with Medtronic’s recent quarterly results highlighting significant growth from its own PFA platform.
Future launches include the Farapoint and Faraflex features of the Farapulse system. Farapoint is expected to launch by the end of this year, with the first rollout set for the EMEA region. Faraflex, a mapping and PFA catheter, remains in the pipeline as well, with ongoing clincial trials.
More the latest indication for the Boston Scientific Farapulse platform
According to Boston Scientific, AFL typically presents with a consistent, yet rapid, heart rhythm. This contrasts to AFib, which usually features a disorganized, irregular and typically fast heart rhythm. Both AFib and AFL represent a significant challenge in Europe, the company says, with the number of cases projected to rise in the coming years.
Farapoint delivers CTI ablation for right AFL. It provides predictable, point-by-point linear and focal lesions across complex heart anatomies and through scar tissue.
Boston Scientific says its catheter performs optimized and controlled lesions with a depth of up to 7 mm. This ensures effective conduction block without compromising the safety of the surrounding cardiac tissue.
The company supported its CE mark submission with data from the ADVANTAGE AF clinical trial. It demonstrated the efficacy and safety of Farapulse and Farapoint as an adjunctive treatment for persistent AFib and AFL. The study found that 97.9% of the 141 patients who received CTI ablation with Farapoint did not experience AFL recurrence. This proved similar to the efficacy rate of 98% seen with radiofrequency ablation, the standard of care.
Similarly, CTI ablation with Farapoint saw comparable safety rates. Boston Scientific said it also provided significantly greater predictability in CTI applications and overall procedure times. It said findings point to real-world procedural reliability with Farapoint.
“The Farapulse PFA platform is a transformational advancement in the treatment of paroxysmal and persistent atrial fibrillation, and the most clinically validated PFA system, with 500,000 patients treated worldwide,” said Caroline Bravo, VP, Rhythm Management EMEA, Boston Scientific. “[This] announcement reflects the strength of the clinical evidence demonstrating Farapulse’s safety, effectiveness and reliability for people living with atrial flutter.”
