Shares of BSX rose more than 5% at $53.58 apiece by afternoon trading today. MassDevice’s MedTech 100, — which includes stocks of the world’s largest medical device companies — was up slightly.
The pivotal ADVENT trial evaluated the nonthermal treatment for ablating heart tissue in patients with AFib. It marks the first randomized clinical trial directly comparing the efficacy and safety of Farapulse against standard-of-care ablation — either radiofrequency or cryoablation — for treating paroxysmal or intermittent AFib.
Boston Scientific presented findings at the annual meeting of the European Society of Cardiology (ESC) in Amsterdam. The company earlier this year presented positive findings for Farapulse from its EU-PORIA registry. It acquired Farapulse and its PFA technology for nearly $300 million in 2021. The system received CE mark in 2021.
Data presented at ESC demonstrated Farapulse’s noninferiority to the standard of care. The system met its primary efficacy and safety endpoints, according to a news release. Boston Scientific noted that the vast majority of physicians only had prior experience with thermal ablation, too.
“These data underscore the superior procedural efficiency of this novel technology, and real-world use continues to yield strong safety and efficacy outcomes,” said Dr. Kenneth Stein, SVP and global chief medical officer, Boston Scientific. “The performance of the Farapulse PFA system in this trial is an encouraging sign of the potential utilization of the device in the U.S., and we look forward to further studying the system for the treatment of patients with persistent AF in the ADVANTAGE AF clinical trial, which began enrollment earlier this year.”
More about the Boston Scientific data
The multicenter, prospective, randomized controlled trial evaluated 607 patients in the U.S. These patients presented paroxysmal AFib with previously unsuccessful treatment with at least one anti-arrhythmic drug.
Through 12 months, Boston Scientific reported 73.3% success for the single-procedure, off-drug treatment in the PFA arm. The thermal arm saw 71.3% treatment success, meaning the study met its primary efficacy endpoint.
Boston Scientific defined its primary composite safety endpoint as acute and chronic device- and procedure-related serious adverse events within seven days of the procedure. The study saw a comparably low adverse event rate of 2.1% in the PFA arm and 1.5% in the thermal arm. PFA reported six adverse events to thermal’s four.
Results demonstrated the superiority of Farapulse in the secondary safety endpoint, the company said. It saw significantly less post-ablation narrowing of the pulmonary veins at three months (0.9%) compared to thermal ablation (12%). Boston Scientific also reported statistically shorter ablation times and less variability with Farapulse. PFA recorded a mean of 29.2 minutes with a standard deviation of 14.3 minutes. Thermal ablation had a mean of 50 minutes with a standard deviation of 24.6 minutes.
Dr. Vivek Reddy, the study’s principal investigator, said Farapulse demonstrated “excellent overall clinical performance.” Reddy, an electrophysiologist at Mount Sinai Hospital, New York, said the high rate of freedom from atrial arrhythmias and the low rate of safety events proved impressive “given the rigor of the trial design and monitoring protocols utilized.”
“These highly anticipated findings, together with extensive prior data from Europe, solidify PFA therapy with this system as a preferred ablative treatment modality,” Reddy said.
The analyst’s view
BTIG analysts Marie Thibault and Sam Eiber maintained their “Buy” rating for Boston Scientific following the presentation of these results.
The analysts say the faster approach, now proven as effective and safe as the standard of care, should become a popular option in the U.S. as it has already become in Europe. They added that Boston Scientific expects FDA approval next year.
“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,” the analysts said.
“We expect Farapulse, along with other key product franchises, can help sustain BSX’s above-peer sales growth.”
The positive Farapulse data marks the latest bit of good news for Boston Scientific’s ablation technologies. Last week, it received expanded FDA 510(k) clearance for its Visual Ice cryoablation system.
Visual Ice’s approval came just weeks after the FDA approved the company’s POLARx cryoablation system for treating paroxysmal AFib.
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