EVOQUE system

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Abbott Taps Growing TMVR Market With Tendyne System
ZACKS· 2025-08-14 13:36
Key Takeaways Abbott gains FDA approval for its Tendyne TMVR system targeting severe mitral annular calcification.Tendyne offers a minimally invasive alternative for high-risk patients unable to undergo open-heart surgery.ABT system's unique, repositionable design adapts to various anatomies for optimal patient outcomes.Abbott Laboratories (ABT) recently received Food and Drug Administration (“FDA”) approval for its Tendyne transcatheter mitral valve replacement (TMVR) system. The Tendyne system replaces mi ...
Should You Add Edwards Lifesciences Stock to Your Portfolio Now?
ZACKS· 2025-07-18 13:31
Core Insights - Edwards Lifesciences is experiencing strong growth in its premium surgical technologies, particularly in the TAVR platform, which is expected to maintain global leadership and sustainable growth [1][9] - The company is also benefiting from a strategic portfolio in Transcatheter Mitral and Tricuspid Therapies, although macroeconomic challenges and currency fluctuations pose risks to its operations [1][9] Financial Performance - Over the past year, Edwards Lifesciences' stock has declined by 11.2%, compared to a 12.9% decline in the industry and a 13.1% growth in the S&P 500 [2] - The company has a market capitalization of $44.66 billion and an earnings yield of 3.2%, which is favorable compared to the industry's -3.6% [2] - In the last four quarters, Edwards surpassed earnings estimates twice and matched on two occasions, with an average surprise of 3.5% [2] Business Segments - The Surgical Structural Heart segment grew by 1% year-over-year in Q1 2025, driven by the adoption of premium surgical technologies like INSPIRIS, MITRIS, and KONECT [4] - TAVR sales exceeded $1 billion for the second consecutive quarter, with strong performance from SAPIEN 3 Ultra RESILIA in the U.S. and Europe [6][9] - The TMTT segment saw a 58% increase in sales in Q1, driven by the adoption of the PASCAL and EVOQUE systems [9][11] Innovations and Developments - Edwards launched the MITRIS system in China, receiving positive feedback from surgeons [5] - The acquisition of Endotronix in 2024 marks the company's entry into implantable heart failure management [5] - The SAPIEN M3 mitral valve replacement system received CE Mark for treating symptomatic mitral regurgitation patients unsuitable for surgery [12] Challenges - The company faces macroeconomic pressures, including inflation, credit market conditions, and geopolitical complications, which are impacting operating results [13] - Foreign exchange fluctuations are a significant headwind, with a 170 basis point decrease in reported sales growth attributed to unfavorable currency impacts [14]