Core Viewpoint - The article discusses the regulatory challenges faced by Edwards Lifesciences in its acquisition of JenaValve Technology, highlighting the significance of the Trilogy system in the transcatheter aortic valve replacement (TAVR) market and the implications for the treatment of aortic regurgitation (AR) [2][10][14]. Group 1: Acquisition and Regulatory Challenges - On August 6, 2025, the FTC filed a lawsuit to block Edwards Lifesciences' acquisition of JenaValve Technology, citing concerns over reduced competition and potential negative impacts on innovation and patient choice [2][11]. - Edwards announced its intention to acquire JenaValve for $1.2 billion (approximately 8.6 billion RMB) in July 2024, aiming to enhance its TAVR product portfolio and address the long-standing treatment gap for AR [2][10]. - The FTC's action reflects a broader scrutiny from global regulatory bodies regarding market concentration in the structural heart disease sector, with the Austrian Federal Competition Authority also initiating a second-phase review of the transaction [12]. Group 2: Trilogy System and Market Implications - The Trilogy system, developed by JenaValve, represents a significant technological advancement in AR treatment, utilizing a self-expanding nitinol frame and a unique anchoring mechanism that does not rely on calcification [5][8]. - The system is designed to address the challenges faced by AR patients, particularly those with non-calcified annuli, and is expected to receive FDA approval by the end of 2025, potentially transforming the AR treatment landscape [8][13]. - Edwards aims to leverage its global sales network and clinical channels to accelerate the commercialization of Trilogy, which could provide a breakthrough treatment option for over 8 million severe AR patients in the U.S. alone [10][14]. Group 3: Financial Performance and Strategic Focus - Edwards Lifesciences has shown strong financial performance, with total revenue increasing by 11.9% year-over-year in Q2 2025, and TAVR sales growing by 8.9%, reflecting confidence in its core business despite regulatory uncertainties [13]. - The company is strategically focusing on expanding its structural heart portfolio, having sold its critical care business for $4.2 billion to BD, indicating a shift towards enhancing its capabilities in the structural heart market [10][13].

报名：首届全球眼科大会 | 议程更新 报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 合作伙伴征集：2025全球手术机器人大会 2025年3月26日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第3号），有 14款 产品进入创新通道。其中包括， 上海申淇医疗科技有限公司 申 请的 抗栓塞脑保护装置 。 抗栓塞脑保护装置 （Cerebral Protection Devices, CPDs ）是专为降低经导管主动脉瓣置换术（Transcatheter Aortic Valve Replacement, TAVR ）过程中 脑卒 中 风险而设计的医疗器械。 # 研发背景 经导管主动脉瓣置换术（TAVR） 是一种用于治疗严重主动脉瓣狭窄的微创手术，手术过程中可能会有血栓或组织碎片脱落，随血流进入脑部，增加脑卒中的风 险。 脑卒中 是经导管主动脉瓣置换术（TAVR）最严重的并发症之一，显著增加患者神经认知功能下降及死亡的风险。随着TAVR适应证逐步扩展至外科低风险患 者群体，脑卒中的预防与治疗愈发重要。 TAVR术后卒中发生率 介于 1.7%-4.8% 之间， 无症状卒 ...