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.
This 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.
Patients with AF are often treated with anti-arrhythmic drugs as well as cardiac ablation. 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. This technology is designed for physicians to precisely ablate tissue and, in turn, spare nearby tissue from unintentional ablation.
Allan Zingeler, president and chief executive officer, Farapulse, said: "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. 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 U.S. and received FDA Breakthrough Designation for its endocardial ablation system in May 2019 – a designation intended to help patients receive more timely access to products that may provide a substantial improvement over existing therapies. The company intends to initiate a pivotal IDE trial in the U.S. and is pursuing CE mark approval in Europe.
Scott Olson, senior vice president and president, rhythm management, Boston Scientific, said: "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.”