波科宣布暂停FARAPULSE临床入组
文摘
健康
2024-10-24 07:54
广东
10月23日，波士顿科学在2024年第三季度的营收报告上透露其明星产品PFA FARAPULSE将暂停临床入组，做出暂停入组的决定是因为在临床试验过程发现了一些未预见的观察结果。
波科CEO Michael Mahoney在营收报告会对此做了简短的说明，在临床试验 AVANT GUARD 研究实验组中，（MedTalks注：为增加一个新适应症），FARAPULSE临床实验有一个新的患者群体：从未接受过药物治疗的持续性房颤患者。但临床入组接近尾声的时候，波科在已入组的患者中，发现了一些意想不到的观察结果，所以他们决定暂时暂停入组，以评估这些观察结果，但这些结果并不是安全性方面的问题。波科CEO还称他们将在短期内重新启动临床入组，并且对FARAPULSE 仍然充满信心。![]()
波科首席医学官Kenneth Stein 做了进一步的说明，对于那些从未接受过药物治疗的持续性房颤患者，现有的临床指南并没有将消融作为治疗的选项，所以这个群体之前一直没有纳入消融的临床实验，也不是FARAPULSE的适应症群体。此次新增入组发现的一些意想不到的观察结果，需要更多的时间来分析和消化，所以波科内部决定（elect）暂停入组。这些意想不到的观察结果并不是关于安全性，并强调到目前为止，FARAPULSE已被用于治疗超过 65 个不同国家的 125000 多名患者，并得到了广泛的临床数据的支持，安全性和有效性没有问题。纵观两者的发言，这个披露看起来并不严重，也不威胁已上市的产品的安全性和有效性，尽管如此，该披露仍被市场分析人士判定为负面消息，对当日的波科的股价波动产生了一些负面的影响。Michael Mahoney We're also studying in a very new patient population of drug-naive
persistent AF patients in AVANT GUARD. As we have neared the end of this
enrollment, we have elected to temporarily pause the trial to assess a few
unanticipated observations. It is our intention to resume enrollments in the
near-term. And based on the totality of clinical evidence and commercial
real-world experience, we remain extremely confident in the unique performance
of FARAPULSE.Kenneth Stein（senior
vice president and global chief medical officer）due
to a few unanticipated observations in the trial which is studying a completely
new population, which is drug-naive patients with persistent AF, which
FARAPULSE is not currently indicated to treat. We did elect to temporarily
pause enrollment until we develop better understanding of the observations.
While none of the observations were life-threatening, we did make a decision to
temporarily pause, but it is our intention to resume enrollments in the
near-term. And this in no way at all affects our confidence in the overall
performance of the FARAPULSE system as it's being used today commercially or in
other clinical trials. Again, as Mike said in his opening comments, we remain
confident that we're going to obtain expanded indication for drug-refractory
persistent AF patients. And that's the data from our ADVANTAGE Phase I
trial. Again, as Mike said, we expect to submit that data to the FDA later this
quarter. We expect to present that data in early 2025, with indication
expansion expected to come in the second half of 2025. And again, I just want
to close by emphasizing that this patient population that we're studying in
AVANT GUARD, which is drug-naive persistent AF patients has not previously been
studied, it's a population that's not indicated for ablation today under guidelines,
and it's not the population that's being treated today with FARAPULSE system.
And I also want to emphasize that we remain highly confident in the global
performance of FARAPULSE, which has now been used to treat more than 125,000
patients across more than 65 different countries and is supported by extensive
clinical data demonstrating positive outcomes for the device. And I think that
also leads into your second question, right, which is why is FARAPULSE going to
maintain category leadership in Pulsed Field Ablation and what's going to
prompt new users to continue to newly adopt the system. And it's several
things. I think, first of all, it's just the compelling ease of use and
straightforward nature of doing the ablation with FARAPULSE. It's just a
tremendous clinical experience that people have when they start using the
system. I am not aware of anyone who started using this and then has stopped
and gone back to thermal ablationObviously because even though we've paused
enrollment for the moment, there's still an ongoing clinical trial. So I really
can't get into any detail on the observations. Again, just to reassure
everyone, nothing that we saw certainly was life-threatening. And I
think we are very highly confident in the overall safety profile, overall
efficacy and again overall efficiency of FARAPULSE system. And again that's
just based on the extensive experience that we've got with it, which is both
commercial experience, as we said, over 125,000 patients now have been treated
with this system globally as well as extensive clinical data that's been
published in approximately 20,000 patients and data that we see from all of our
ongoing clinical trials.原文链接：https://www.investing.com/news/stock-market-news/earnings-call-boston-scientific-reports-robust-q3-growth-raises-outlook-93CH-3678348
