The Farapulse (left) and Watchman FLX Pro (right) systems. [Images courtesy of Boston Scientific]

Farapulse（左）和Watchman FLX Pro（右）系统。

Boston Scientific

波士顿科学

(NYSE: BSX)

（纽约证券交易所：BSX）

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today reported data from separate studies backing its Farapulse and Watchman FLX systems.

今天报道了支持Farapulse和Watchman FLX系统的独立研究数据。

The data comes just days after CEO Mike Mahoney singled out the two platforms as key growth drivers for the company moving forward.

就在几天前，首席执行官迈克·马奥尼（MikeMahoney）将这两个平台列为公司前进的关键增长驱动因素。

Speaking at the JP Morgan Healthcare Conference, Mahoney talked about how they could spur growth

在摩根大通医疗保健会议上，马奥尼谈到了如何刺激增长

— including in conjunction with one another.

-包括相互结合。

Today, Boston Scientific announced data from the ADVANTAGE AF and OPTION trials supporting Farapulse and Watchman FLX, respectively. Investigators presented findings at the 30th annual AFib Symposium in Boston.

今天，波士顿科学宣布了ADVANTAGE AF和OPTION试验的数据，分别支持Farapulse和Watchman FLX。研究人员在波士顿举行的第30届亚投行年会上介绍了研究结果。

Farapulse, a pulsed-field ablation (PFA) system for treating AFib, received a

Farapulse是一种用于治疗AFib的脉冲场消融（PFA）系统

much-anticipated FDA approval

备受期待的FDA批准

last year. Mahoney said that, with Farapulse, Boston Scientific “disrupted and transformed a hot, large market” in electrophysiology. With Watchman FLX, a left atrial appendage closure (LAAC) device, Mahoney said the company essentially “created this [LAAC] market over many years.”

。马奥尼说，有了法拉脉冲，波士顿科学公司（Boston Scientific）“打破并改变了电生理学的一个热门大市场”。马奥尼说，有了左心耳闭合（LAAC）装置Watchman FLX，该公司基本上“多年来创造了这个（LAAC）市场”

Boston Scientific reported that Farapulse met its primary safety and efficacy endpoints. Watchman FLX delivered consistent outcomes in concomitant and sequential subgroups.

Boston Scientific报道，法拉普尔符合其主要安全性和有效性终点。Watchman FLX在伴随和连续的亚组中提供了一致的结果。

More on the performance from the Boston Scientific Farapulse system

有关波士顿科学法拉脉冲系统性能的更多信息

ADVANTAGE AF looked at Farapulse for both pulmonary vein isolation (PVI) and posterior wall ablation (PWA). It evaluated patients with persistent AFib with an irregular or rapid heartbteat lasting longer than seven days. This represents 25% of all AFib cases, the company says.

ADVANTAGE AF研究了Farapulse用于肺静脉隔离（PVI）和后壁消融（PWA）。它评估了持续性AFib患者的不规则或快速心跳持续时间超过7天。该公司表示，这占所有亚投行案例的25%。

Farapulse met its primary safety endpoint, defined as serious adverse events related to either the use of an ablation catheter or the ablation procedure within seven days of the primary procedure and pulmonary vein stenosis or atrio-esophageal fistula out to 12 months. Boston Scientific reported a 2.3% event rate..

Farapulse达到了其主要安全终点，定义为在主要手术后7天内使用消融导管或消融手术以及肺静脉狭窄或心房食管瘘持续12个月的严重不良事件。。。

Additionally, the system met the primary effectiveness endpoint, defined as freedom from AF, atrial flutter, atrial tachycardia, re-ablation, cardioversion and use of a new or escalated dose of Class I/III AAD or amiodarone. That rate came in at 63.5%.

此外，该系统符合主要有效性终点，定义为无房颤，心房扑动，房性心动过速，再次消融，复律以及使用新剂量或递增剂量的I/III类AAD或胺碘酮。这一比率为63.5%。

Investigators reported a symptomatic AF recurrence-free rate of 85.3%. Physicians that performed three or more procedures in the trial reported an even higher rate at 91.8%. Boston Scientific reports no incidences of stroke, pulmonary vein stenosis, atrio-esophageal fistula or major access complications..

研究人员报告有症状的房颤无复发率为85.3%。在试验中进行三次或三次以上手术的医生报告的比率更高，为91.8%。Boston Scientific报告没有中风，肺静脉狭窄，心房食管瘘或主要通路并发症的发生率。。

Highlights from the OPTION sub-analysis

选项子分析的要点

OPTION, a randomized head-to-head study, compares Watchman technology to direct oral anticoagulants (95% DOACs, 5% warfarin) after cardiac ablation. Data presented today fell in line with previously shared safety and efficacy data

OPTION是一项随机的头对头研究，将Watchman技术与心脏消融后直接口服抗凝剂（95%DOAC，5%华法林）进行比较。今天提供的数据与之前共享的安全性和有效性数据一致

presented at the American Heart Association’s Scientific Sessions 2024

在2024年美国心脏协会科学会议上发表

and simultaneously published in

并同时发表在

The New England Journal of Medicine

新英格兰医学杂志

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Findings from a new, prespecified analysis came from 1,600 patients with AFib. Those patients underwent a device implantation either concomitantly or sequentially (90-180 days post-ablation).

。这些患者同时或顺序（消融后90-180天）接受了器械植入。

Concomitant LAAC with Watchman FLX post-ablation demonstrated a statistically significant reduction (44%) in non-procedural bleeding outcomes compared to OAC at 36 months. Those outcomes came in at 8% and 13%, respectively. This method produced similar efficacy outcomes (7% vs. 6.7%) with regard to all-cause death, stroke or systemic embolism..

与36个月的OAC相比，伴随LAAC和Watchman FLX消融后显示非手术性出血结果的统计学显着降低（44%）。这些结果分别为8%和13%。该方法在全因死亡，中风或全身性栓塞方面产生了相似的疗效结果（7%比6.7%）。。

Sequential LAAC produced a statistically significant (62%) reduction in non-procedural bleeding outcomes compared to OAC at 36 months. Those outcomes came in at 8.8% and 21.5%, respectively. Again, Boston Scientific reported similar efficacy outcomes (4.2% vs. 5.3%).

与36个月的OAC相比，序贯LAAC在非手术性出血结局方面产生了统计学显着（62%）的减少。这些结果分别为8.8%和21.5%。同样，波士顿科学报道了类似的疗效结果（4.2%比5.3%）。

Data highlighted similar stroke protection with Watchman FLX compared to OAC, irrespective of the method of implantation. The concomitant group produced 2.3% (LAAC) and 2.5% (OAC) rates of all stroke. The sequential group saw 1.1% vs. 1.6% in the respective groups.

数据强调了Watchman FLX与OAC相比具有类似的中风保护作用，无论植入方法如何。伴随组的所有卒中发生率分别为2.3%（LAAC）和2.5%（OAC）。顺序组分别为1.1%和1.6%。

The analysts’ take

分析师的看法

BTIG analysts Marie Thibault, Sam Eiber and Alexandra Pang believe the data supports anticipated label expansions for the technologies.

BTIG分析师玛丽·蒂博尔特（MarieThibault）、萨姆·艾伯（SamEiber）和亚历山德拉·庞（AlexandraPang）认为，这些数据支持了这些技术的预期标签扩展。

Specifically, they say the ADVANTAGE AF results should support expansion into persistent AFib later this year. Boston Scientific anticipates a Watchman label update in the second half of 2025, too.

具体来说，他们表示，ADVANTAGE AF的结果应该支持今年晚些时候向持续性AFib的扩张。波士顿科学公司（Boston Scientific）预计，Watchman标签也将在2025年下半年更新。

The analysts highlighted the importance of experience with Farapulse, as made evident by the increased success for physicians using the system three or more times.

分析人士强调了使用法拉脉冲的经验的重要性，医生使用该系统三次或三次以上的成功率增加就证明了这一点。

Meanwhile, both platforms coming into play with concomitant procedures could prove fruitful for Boston Scientific, they said.

。

“We think Watchman LAAC with ablation (often PFA) performed concomitantly will continue to gain popularity, supported by a recent reimbursement code,” the analysts wrote. “We believe that positive outcomes from the trial, coupled with the new DRG, may help support the economic value proposition of conducting concomitant LAAC and PFA procedures using Watchman.”.

“我们认为，伴随消融（通常是PFA）的Watchman LAAC将继续受到欢迎，并得到最近报销代码的支持，”分析师写道。“我们认为，试验的积极结果，加上新的DRG，可能有助于支持使用Watchman同时进行LAAC和PFA程序的经济价值主张。”。