Boston Scientific Announces Expanded Technology Investment with Exclusive Equity Acquisition Agreement for Farapulse

MARLBOROUGH, Mass., Sept. 25, 2020 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) recently announced that it has signed an investment agreement with Farapulse, Inc. for an exclusive equity acquisition. Farapulse is a private company focused on developing pulsed field ablation (PFA) systems for the treatment of atrial fibrillation (AF) and other arrhythmias. The PFA system consists of a sheath, generator, and catheter, and can ablate cardiac tissue by generating therapeutic electric fields without using thermal energy sources such as radiofrequency ablation or cryoablation.

Atrial fibrillation is a common arrhythmia, with over 33 million patients worldwide who typically require treatment with antiarrhythmic drugs and cardiac ablation.^[i]Ablation therapy refers to the delivery of energy to the myocardial region responsible for cardiac arrhythmias. The Farapulse platform employs a pulsed field ablation modality—also known as "irreversible electroporation."”, thereby creating ablated regions of cardiac tissue to block irregular electrical signals that may cause atrial fibrillation. This technology enables precise ablation while ensuring that tissues near the target remain unaffected.

Allan Zingeler, President and Chief Executive Officer of Farapulse, Inc., stated, “The tissue-selective pulsed field ablation (PFA) technology developed by Farapulse offers an alternative approach to cardiac ablation procedures, including pulmonary vein isolation. Recent study results have also demonstrated the efficacy of this ultra-rapid method. Our partnership with Boston Scientific will help accelerate regulatory approval, enabling us to bring our pioneering system to market more quickly.”

Farapulse, Inc. is currently seeking approval from the U.S. Food and Drug Administration (FDA). Its developed endocardial ablation system received the FDA’s “Breakthrough Therapy Designation” in May 2019, a status that facilitates earlier patient access to products potentially offering significant improvements over existing therapies. The company has planned to conduct pivotal Investigational Device Exemption (IDE) trials in the United States and is also actively pursuing CE marking in Europe.

Scott Olson, Senior Vice President and President of the Cardiac Rhythm Management business at Boston Scientific Corporation, stated, “By expanding our investment in this technology, combined with the recent launch of our CE-marked cryoablation system and pressure-sensing catheters featuring local impedance technology, we remain committed to providing physicians with an innovative and comprehensive portfolio of electrophysiology products and services.”

*The Farapulse platform is an investigational device and is not currently available for sale.

[i] Chugh SS, et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation 2014;129:837–847. doi: https://doi.org/10.1161/CIRCULATIONAHA.113.005119.

*Translated from the official Boston Scientific website