Boston Scientific has signed an investment agreement and an exclusive option to acquire Farapulse, the developer of the pulsed-field ablation (PFA) system. The move has the potential to strengthen the Marlborough, MA-based company’s position in the treatment of atrial fibrillation.
The Menlo Park, CA-based company is received breakthrough designation for the PFA system in May of 2019. The device – 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.
Farapulse said it intends to initiate a pivotal IDE trial and is pursuing CE Mark approval in Europe.
"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 CEO, Farapulse, Inc, said in a 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."
The agreement has shades of Boston Scientific’s deal with Millipede Inc., developer of the transcatheter annuloplasty ring system for the treatment of severe mitral regurgitation. Recall in 2018, Boston Sci, while in the middle of an M&A spree, picked up the remaining shares of the Santa Rosa, CA-based company for $325 million. Boston Scientific had taken a $90 million stake in Millipede earlier that year.