Less than a year after Boston Scientific expanded its longstanding partnership with Farapulse, sparks are definitely flying between the two—culminating in the device maker's decision to fold Farapulse’s electric field generation technology into its own electrophysiology portfolio.
Boston Scientific has exercised an option to acquire Farapulse in full, per that September 2020 agreement. The company already holds a 27% stake in Farapulse and will put down about $295 million to pick up the remainder.
After the initial transaction is complete, Boston Scientific will offer up additional financial incentives as Farapulse’s technology hits certain milestones, with clinical and regulatory goals being rewarded with up to $92 million. Farapulse will also rake in revenue-based payments of an undisclosed amount through the end of 2023.
With Boston Scientific’s support, Farapulse will be able to accelerate its work toward FDA clearance for its ablation system for atrial fibrillation and other cardiac arrhythmias, Allan Zingeler, the company’s president and CEO, said in a statement.
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Its new parent company—which has been on an M&A streak as of late, purchasing wearable heart monitor maker Preventice for $1.2 billion in January and Lumenis’ surgical laser business for $1 billion in March—will also reap the rewards.
The Farapulse Pulsed Field Ablation System differs from traditional ablation treatments for afib and arrhythmia in that it relies on electric fields rather than extremely hot or cold temperatures to inhibit the abnormal cardiac signals that cause rapid or irregular heartbeats.
Treatment with the device begins like any other ablation system, with a catheter inserted into the heart’s left atrium via the left superior pulmonary vein. Once there, however, Farapulse’s technology creates a therapeutic electric field—in a process also known as irreversible electroporation—that interrupts those abnormal electrical signals.
In contrast to other ablation techniques, pulsed field ablation can be directed at specific heart tissue, avoiding damaging nearby tissues in the esophagus, major nerves and more, as is often the case in thermal or cryoablation.
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“The emerging field of [pulsed field ablation] has the potential to alter the future of ablation therapy and has shown the promise of improvements in both safety of cardiac ablations for patients and efficiency and ease-of-use of these procedures for physicians,” said Kenneth Stein, senior vice president and chief medical officer of rhythm management and global health policy at Boston Scientific.
“The Farapulse PFA System is intended to enable physicians to precisely ablate cardiac tissue while minimizing procedural complications, and real-world and clinical evidence from trials throughout Europe have demonstrated encouraging, positive results,” Stein added.
The system received a CE mark in the first quarter of this year, making it commercially available in Europe. Around the same time, Farapulse kicked off its FDA-cleared clinical trial of the system—which will compare the effects of the PFA treatment on intermittent afib compared to traditional ablation methods—in its pursuit of U.S. clearance.