US-based medical device manufacturer Boston Scientific has received the US Food and Drug Administration (FDA) approval for its Farapulse pulsed field ablation (PFA) System.
The Farapulse PFA System is designed to deliver pulsed field energy, optimise cardiac PFA therapy, and provide a simplified user experience.
It is indicated for the isolation of pulmonary veins during the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (AF).
The PFA System primarily contains three components, the Farawave Ablation Catheter, the Farastar Ablation Generator, and the Faradrive Steerable Sheath.
The Faradrive Steerable Sheath is complemented by the VersaCross Connect Access Solution to provide safe and effective access to the left side of the heart during procedures.
The Farawave Ablation Catheter treats a range of PV anatomies using an over-the-wire catheter with variable basket and flower shapes, allowing the device to conform with patient anatomies.
Also, the Farastar PFA Generator is designed to prepare, confirm, and deliver the therapy using bipolar and biphasic waveforms with unique pulses.
The Farapulse PFA System is a new alternative to standard-of-care thermal ablation treatment, and its configurations promote reproducible procedures between operators, said the medical device manufacturer.
Boston Scientific electrophysiology president Nick Spadea-Anello said: “The approval of the FARAPULSE PFA System marks an important milestone for the millions of people living with paroxysmal AF and is an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the U.S.
“A high bar has been set by the performance of the system in clinical and commercial settings – where more than 40,000 patients have been treated to date – and we look forward to continuing to lead the way with this differentiated technology in the growing PFA space.”
In a traditional ablation procedure, a catheter is guided to the interior of the heart to generate extremely high or low temperatures to destroy areas associated with abnormal heart rhythms.
Boston Scientific said that its Farapulse PFA System will leverage tissue-selective, non-thermal electric fields to ablate heart tissue, preventing any damage to the surrounding structures.
The system has been evaluated in the ADVENT clinical trial, the first randomised clinical trial to directly compare the efficacy and safety of the system against standard-of-care ablation,
In the study, Farapulse showed comparable safety and effectiveness as conventional thermal ablation, with shorter ablation times and a faster learning curve for physicians.
Also, data from the MANIFEST-17K registry showed continued real-world safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or oesophageal injury.
In 2019, Farapulse secured the Breakthrough Device Designation from the FDA’s Centre for Devices and Radiological Health (CDRH), followed by CE Mark in 2021.
With the FDA approval now granted, Boston Scientific plans to immediately commercialise the system in the US.
Furthermore, the company is developing a navigation-enabled version of the Farawave catheter alongside the Faraview Software Module, targeting their regulatory approval in 2024.
