Boston Scientific has signed an investment agreement with an exclusive option to acquire Farapulse, a privately-held company developing a pulsed field ablation (PFA) system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias.
The PFA system—comprising a sheath, generator and catheters—is intended to ablate heart tissue via the creation of a therapeutic electric field instead of using thermal energy sources such as radiofrequency ablation or cryoablation.
Ablation therapy is the process of delivering energy to areas of the heart muscle responsible for creating an abnormal heart rhythm. The Farapulse platform employs an ablation modality based on pulsed electric fields, also referred to as irreversible electroporation, that generates zones of ablated cardiac tissue to interrupt the irregular electrical signals that can cause AF. The technology is designed for physicians to precisely ablate tissue and, in turn, spare nearby tissue from unintentional ablation.
“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,” said Allan Zingeler, president and chief executive officer, Farapulse. “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.”
Farapulse is pursuing regulatory approval in the USA and received US Food and Drug Administration (FDA) Breakthrough Designation for its endocardial ablation system in May 2019. The company intends to initiate a pivotal investigational device exemption (IDE) trial in the USA and is pursuing 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,” said Scott Olson, senior vice president and president, Rhythm Management, Boston Scientific.