WASHINGTON - Edwards Lifesciences Corporation (NYSE: NYSE:EW) announced today that its EVOQUE transcatheter tricuspid valve replacement (TTVR) system has shown positive results in the TRISCEND II trial, demonstrating superiority to medical therapy alone in treating patients with severe tricuspid regurgitation (TR). The findings were presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting and will be published in The New England Journal of Medicine and the Journal of the American College of Cardiology.
The TRISCEND II trial, a randomized controlled study, involved 400 patients who received either the EVOQUE system with optimal medical therapy (OMT) or OMT alone. The EVOQUE valve was successfully implanted in 95.4 percent of patients in the treatment group, with 95.3 percent achieving nearly complete TR elimination at one year. In contrast, only 2.3 percent of patients on OMT alone experienced similar TR reduction. These results were linked to significant improvements in symptoms, function, and quality of life (QoL), as well as favorable trends in mortality and heart failure hospitalization rates.
Dr. Susheel Kodali, one of the study's principal investigators, highlighted the EVOQUE system as a significant development for patients with limited treatment options. Dr. Suzanne Arnold also noted the sustained QoL benefits for patients receiving the EVOQUE system, with those treated being twice as likely to be alive with a good QoL after one year compared to the control group.
The EVOQUE system, approved in both Europe and the United States, is the only TTVR system currently available worldwide. It comes in four sizes, with the largest size recently receiving U.S. approval.
Daveen Chopra, Edwards' corporate vice president, emphasized the company's dedication to providing evidence-backed therapies for structural heart diseases. Edwards Lifesciences is recognized as a global leader in structural heart innovation, committed to improving patient lives through advanced technologies.
The company cautions that the statements made regarding expected product benefits and patient outcomes are forward-looking and subject to risks and uncertainties. These results are based on estimates and assumptions by the company's management and are not guaranteed future performance indicators.
This news article is based on a press release statement from Edwards Lifesciences Corporation.
In other recent news, Edwards Lifesciences has reported robust growth in the third quarter, with sales reaching $1.35 billion, marking a 10% increase from the previous year. This growth was significantly driven by the company's Transcatheter Aortic Valve Replacement (TAVR) and Transcatheter Mitral and Tricuspid Therapies (TMTT), with TAVR sales hitting $1 billion and TMTT sales surging 74% to $91 million. Meanwhile, TD Cowen has maintained its Hold rating on Edwards Lifesciences, with a steady price target of $70.00, focusing on the potential label expansion of Evoque following the upcoming presentation of the Triscend II trial results. The firm suggests that the forthcoming data could substantiate a mortality benefit for Evoque, enhancing its current label. Furthermore, Edwards Lifesciences has been upgraded from Underperform to Market Perform by Bernstein, acknowledging a shift in the TAVR market dynamics. The company anticipates continued growth in TAVR and TMTT, with full-year growth guidance for TAVR steady at 5% to 7%. These are among the latest developments for Edwards Lifesciences.
InvestingPro Insights
Edwards Lifesciences' recent breakthrough with the EVOQUE system aligns well with its strong financial performance and market position. According to InvestingPro data, the company boasts a market capitalization of $42.38 billion, reflecting its significant presence in the medical devices sector.
The company's innovative focus is evident in its robust revenue growth of 17.76% over the last twelve months, reaching $6.31 billion. This growth trajectory supports Edwards' ability to invest in groundbreaking technologies like the EVOQUE system. Moreover, the company's strong gross profit margin of 76.6% indicates efficient cost management, which is crucial for sustaining research and development efforts in advanced medical technologies.
InvestingPro Tips highlight that Edwards Lifesciences is trading at a low P/E ratio relative to its near-term earnings growth, suggesting potential undervaluation despite its recent clinical success. The company's ability to generate sufficient cash flows to cover interest payments, coupled with its moderate debt level, provides financial flexibility to pursue further innovations in structural heart treatments.
It's worth noting that while Edwards doesn't pay a dividend, it has been aggressively buying back shares, potentially signaling management's confidence in the company's future prospects. This strategy aligns with the company's focus on long-term growth through technological advancements like the EVOQUE system.
For investors interested in a deeper analysis, InvestingPro offers 10 additional tips for Edwards Lifesciences, providing a more comprehensive view of the company's financial health and market position.
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