Boston Scientific has signed an investment agreement with privately held medical device company Farapulse with an exclusive option for acquisition.
The financial details of the deal were not disclosed.
Farapulse develops pulsed-field ablation (PFA) system to treat atrial fibrillation (AF) and other cardiac arrhythmias.
The PFA system, which consists of a sheath, generator and catheters, is designed to ablate heart tissue by forming a therapeutic electric field instead of using thermal energy sources, including radiofrequency ablation or cryoablation.
AF is a common heart rhythm disorder, which is often treated with anti-arrhythmic drugs, as well as cardiac ablation. Ablation therapy provides energy to areas of the heart muscle responsible for causing abnormal heart rhythm.
The Farapulse platform uses an ablation modality based on pulsed electric fields, also known as irreversible electroporation. It creates zones of ablated cardiac tissue to interrupt the irregular electrical signals that can cause AF.
The technology is designed to help physicians accurately ablate tissue, eliminating the chance for unintentional ablation of surrounding tissue.
Farapulse president and CEO Allan Znigeler 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 currently pursuing regulatory approval in the US. The company secured the Food and Drug Administration (FDA) breakthrough designation for its endocardial ablation system in May last year. It plans to begin a pivotal IDE trial in the US and is pursuing CE Mark approval in Europe.
Boston Scientific Rhythm Management senior vice-president and president Scott Olson 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 offering physicians an innovative and comprehensive of portfolio electrophysiology products and services.”