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].