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CMS启动Abbott TriClip系统的覆盖范围审查

CMS initiates coverage review for Abbott TriClip system

MASSDEVICE 等信源发布 2024-10-04 00:02

可切换为仅中文


The TriClip transcatheter tricuspid valve repair system [Image courtesy of Abbott]The Centers for Medicare & Medicaid Services (CMS) accepted a formal request to provide a national coverage analysis (NCA) for the Abbott

TriClip经导管三尖瓣修复系统[图片由雅培提供]医疗保险和医疗补助服务中心(CMS)接受了为雅培提供全国覆盖分析(NCA)的正式请求

(NYSE: ABT)

(纽约证券交易所:ABT)

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TriClip.

TriClip。

BTIG analysts Marie Thibault and Sam Eiber say Abbott requested the NCA for its transcatheter edge-to-edge repair system for treating tricuspid valve regurgitation (T-TEER). It falls under a pilot through the Transitional Coverage of Emerging Therapy (TCET) pathway.

BTIG分析师玛丽·蒂博尔特(MarieThibault)和山姆·艾伯(SamEiber)表示,雅培(Abbott)要求NCA提供用于治疗三尖瓣返流(T-TEER)的经导管边缘到边缘修复系统。它属于新兴治疗过渡覆盖(TCET)途径的试点。

Abbott designed TriClip to treat tricuspid regurgitation (TR), or a leaky tricuspid valve. Delivered through a vein in the leg, the TriClip TEER technology clips together a portion of leaflets. It repairs the tricuspid valve and helps blood flow in the right direction without the need for open-heart surgery.

雅培设计TriClip治疗三尖瓣关闭不全(TR)或三尖瓣渗漏。TriClip TEER技术通过腿部静脉输送,将一部分传单夹在一起。它可以修复三尖瓣,帮助血液流向正确的方向,而无需进行心脏直视手术。

The system received FDA approval in April..

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TriClip could offer a new option for those who continue to have symptoms or persistent TR despite treatment with medical therapy. It now enters the U.S. TR treatment market that features the Edwards Evoque tricuspid valve. Evoque became the first transcatheter therapy approved to treat TR in February..

TriClip可能为那些尽管接受了药物治疗但仍有症状或持续TR的患者提供了一种新的选择。它现在进入了以爱德华兹Evoque三尖瓣为特征的美国TR治疗市场。Evoque于2月成为第一个被批准用于治疗TR的经导管疗法。。

CMS’ NCA begins with a public comment period that remains open for the next 30 days. The analysts noted a due date of April 3, 2025, for a proposed decision memo. They expect a completed NCA by July 2, 2025. According to Thibault and Eiber, Abbott’s letter to CMS acknowledged national coverage determinations (NCDs) for mitral TEER coverage and transcatheter aortic valve replacement (TAVR), noting that CMS could consider a therapy-focused NCD organization that could include TEER for both mitral and tricuspid valves..

CMS的NCA以公众评论期开始,该评论期将持续30天。分析师指出,拟议的决策备忘录的截止日期为2025年4月3日。他们预计在2025年7月2日之前完成NCA。根据Thibault和Eiber的说法,Abbott给CMS的信承认了二尖瓣TEER覆盖率和经导管主动脉瓣置换术(TAVR)的国家覆盖率测定(NCDs),并指出CMS可以考虑一个以治疗为重点的NCD组织,该组织可以包括二尖瓣和三尖瓣的TEER。。

“We are pleased to see this announcement, which comes as expected after the FDA approved TriClip in April and since in recent commentary, management anticipated the NCD process starting soon,” the analysts concluded.

分析人士总结道:“我们很高兴看到这一宣布,这是在FDA于4月份批准TriClip之后,正如预期的那样,因为在最近的评论中,管理层预计非传染性疾病进程将很快开始。”。