Medical devices manufacturer Boston Scientific has signed an investment agreement, with an exclusive option to acquire Farapulse, the developer of pulsed field ablation (PFA) system.
Comprising a sheath, generator and catheters, the PFA system is designed to ablate heart tissue by creating a therapeutic electric field rather than using thermal energy sources including radiofrequency ablation or cryoablation.
Farapulse president and chief executive officer Allan Zingeler 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 platform employs an ablation modality based on pulsed electric fields
Patients with AF are often treated with anti-arrhythmic drugs along with cardiac ablation therapy, a process of delivering energy to the heart muscles responsible for creating an abnormal heart rhythm.
The Farapulse platform leverages an ablation modality based on pulsed electric fields to create zones of ablated cardiac tissue to interfere with the irregular electrical signals that are responsible for causing AF.
The company has designed the technology to enable physicians precisely ablate the tissue and, and also spare the surrounding tissue from accidental undesired ablation.
Farapulse has received FDA Breakthrough Designation for its endocardial ablation system in May 2019, and is currently seeking regulatory approval in the US.
The company is planning to commence an IDE clinical trial in the US and is seeking 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 offer physicians an innovative and comprehensive portfolio of electrophysiology products and services.”
Recently, Boston Scientific has gained CE mark approval for its fourth-generation Vercise Genus deep brain stimulation (DBS) system.
