Menlo Park, Calif.-based Farapulse has developed a pulsed-field ablation (PFA) system for treating atrial fibrillation (Afib) and other cardiac arrhythmias. The PFA system is designed with a sheath, a generator and catheters to ablate heart tissue through a therapeutic electric field instead of using thermal energy sources like radiofrequency ablation or cryoablation, according to a news release.
“The tissue-selective Farapulse PFA technology is a promising energy source for cardiac ablation – including pulmonary vein isolation – with recent study results demonstrating the effectiveness of the ultra-rapid approach,” Farapulse president & CEO Allan Zingeler said in the release. “This next chapter in our collaborative relationship with Boston Scientific will further accelerate our progress towards regulatory approval so we can bring this pioneering system to market.”
As its platform is not yet available for sale in the U.S., Farapulse is pursuing regulatory approval from the FDA, having already received breakthrough device designation for the endocardial ablation system in May 2019. The company is also planning to begin a pivotal investigational device exemption trial in the U.S. and will seek CE Mark approval in Europe.
“Our expanded investment in this technology, combined with our recent CE Marked cryoablation and contact force catheters with local impedance technology, affirms our commitment to offer physicians an innovative and comprehensive portfolio of electrophysiology products and services,” Boston Scientific senior VP & president of its rhythm management business Scott Olson said.