Data from more than 17,000 patients in the MANIFEST 17K registry reinforced the real-world safety profile for the pulsed-field ablation (PFA) system. Results included no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury. The company reported an overall major adverse event rate of less than 1%.
The registry included outcomes ranging across 106 hospitals, according to Boston Scientific. Data also reinforced the reproducibility of the therapy workflow and short learning curve in uncontrolled commercial use.
Boston Scientific presented its Farapulse data at the 2023 American Heart Association (AHA) Scientific Sessions. The company discussed Farapulse at its Investor Day event earlier this year — read more about it here.
Farapulse PFA provides an alternative to thermal ablation, allowing physicians to ablate cardiac tissue while reducing the risk to surrounding structures. Boston Scientific’s latest data adds to a growing body of evidence supporting PFA as a treatment for AFib.
The company earlier this year presented positive findings for Farapulse from its EU-PORIA registry. In August, Boston Scientific had even more positive data for the system, leading to suggestions that FDA approval and rapid adoption could follow.
Boston Scientific acquired Farapulse and its PFA technology for nearly $300 million in 2021. The system received CE mark in 2021.
The company also presented further positive data from its IntellaNav StablePoint catheter and force sensing system. Data in the NEwTON-AF IDE trial met all safety and efficacy endpoints. The company reported an acute procedural success rate of 93%. Freedom from documented AFib recurrence came in at 73.9% at 12 months.
