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The treatment doesn’t use heat, but rather electric fields to carefully remove a small amount of heart tissue. This study was the first one that directly compared the FARAPULSE PFA System to the usual treatments – either radiofrequency or cryoablation.
The findings from this study were shared at the ESC Congress 2023.
“Excellent overall clinical performance of the FARAPULSE PFA System was seen in this study, particularly the high rate of freedom from atrial arrhythmias and the very low rate of safety events, which is impressive given the rigor of the trial design and monitoring protocols utilized,” said Vivek Reddy, M.D., study principal investigator and electrophysiologist at Mount Sinai Hospital, New York.
“These highly anticipated findings, together with extensive prior data from Europe, solidify PFA therapy with this system as a preferred ablative treatment modality.”
Over 12 months, the FARAPULSE worked just as well as the regular treatments. About 73.3% of people who got the new treatment saw success, compared to 71.3% of those who got the regular treatments – meeting the primary efficacy endpoint.
The study also looked at safety. They wanted to see if the new treatment was safe and didn’t cause too many problems. The FARAPULSE had a low rate of bad events – 2.1% of people had issues related to the procedure, compared to 1.5% with the regular treatments.
BSX continues to anticipate FDA approval for Farapulse in 2024.
BTIG analysts expect the FDA approval and “rapid adoption” following positive results.
“We think these results were in line with to slightly better than many investors expected, though we expect some focus on the death in the PFA arm. Given how anticipated these data were and the relatively in-line findings, we would not be surprised by minor weakness in BSX shares following this catalyst. We expect Farapulse, along with other key product franchises, can help sustain BSX’s above-peer sales growth. Reiterate Buy.”
Similarly, BofA analysts said the ADVENT was a “highly successful readout.” They see Farapule as a “confirmed 2024-2025 growth driver.”
“ADVENT supports BSX taking it up to another level and we see BSX in a position to deliver some of the best revenue and EPS growth in medtech and we maintain our Buy rating. BSX will host its analyst day on Sept 20th where BSX likely gives more detail on its PFA pipeline (farapoint/faraflex),” the analysts wrote.
