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Edwards Lifesciences Corp (NYSE: EW) is a pioneering global entity in the realm of heart valve technology and hemodynamic monitoring. Headquartered in Irvine, California, the company has a robust presence across North America, Europe, Japan, Latin America, and Asia, employing approximately 6,400 individuals worldwide. Edwards Lifesciences specializes in developing medical devices and technologies that address structural heart disease and critical care monitoring, aiming to save and enhance patients' lives.
Originating from a spin-off of Baxter International in 2000, Edwards Lifesciences has cemented its position as a leader in manufacturing and marketing advanced medical equipment. The company's core products include surgical tissue heart valves, transcatheter valve technologies, surgical clips, and catheters. These innovations have positioned Edwards Lifesciences as a key player in the medical field, particularly in the areas of heart valve replacement and repair.
Edwards Lifesciences generates about 55% of its sales from international markets, showcasing its extensive global reach. The company's commitment to innovation is evident in its continuous development of technologies that monitor vital signs in critical care settings, ensuring that patients improve their quality of life.
Recently, Edwards Lifesciences announced a significant transaction with Becton, Dickinson and Company (BD), where BD will acquire Edwards' Critical Care product group for $4.2 billion in cash. This acquisition is expected to unlock new value creation opportunities and enhance BD's portfolio of smart connected care solutions. The Critical Care unit, known for its advanced patient monitoring solutions and AI-driven technologies, will operate as a separate business unit within BD's Medical segment, maintaining its base in Irvine.
The transaction is anticipated to be immediately accretive to all key financial measures, with a strong focus on revenue growth, adjusted gross and operating margins, and adjusted earnings per share. It highlights Edwards Lifesciences' strategic intent to drive innovation and value through partnerships and strategic acquisitions.
Edwards Lifesciences (NYSE: EW) presented new clinical data at the Transcatheter Cardiovascular Therapeutics (TCT) conference, emphasizing its commitment to structural heart innovation. The data from the EARLY TAVR and TRISCEND II trials highlighted the importance of early intervention in severe aortic stenosis and the benefits of transcatheter mitral and tricuspid therapies (TMTT). Key findings included improved outcomes and reduced healthcare costs for patients receiving timely treatment. Specific studies showcased the efficacy of TAVR in asymptomatic severe aortic stenosis patients and women, and the long-term benefits of the PASCAL system in treating mitral regurgitation. Additionally, the TWIST study demonstrated promising results for Innovalve in mitral valve replacement. These findings support Edwards' growth and innovation in treating structural heart disease.
Edwards Lifesciences (NYSE: EW) announced superior one-year results for its EVOQUE transcatheter tricuspid valve replacement system in the TRISCEND II trial. The study, involving 400 patients with severe tricuspid regurgitation, showed 95.4% successful implantation rate. 95.3% of treated patients achieved near-complete tricuspid regurgitation elimination at one year, compared to just 2.3% in the control group receiving optimal medical therapy alone. The EVOQUE system, now approved in both Europe and US, demonstrated significant improvements in symptoms, function, and quality of life, with favorable trends in mortality and heart failure hospitalization.
Edwards Lifesciences (NYSE: EW) announced groundbreaking results from the EARLY TAVR Trial, demonstrating superior outcomes for asymptomatic severe aortic stenosis patients treated with TAVR compared to clinical surveillance. The trial, involving 901 patients across 75 sites in the US and Canada, showed that 26.8% of TAVR patients experienced death, stroke, or unplanned cardiovascular hospitalization versus 45.3% in the surveillance group over a 3.8-year median follow-up. Early TAVR intervention prevented rapid symptom progression and quality of life decline, with lower stroke rates (4.2% vs 6.7%). Notably, 26.2% of surveillance patients required valve replacement within six months, rising to 47.2% at 12 months.
Edwards Lifesciences (NYSE: EW) reported Q3 2024 financial results with total sales growth of 9% (10% constant currency) from continuing operations. TAVR sales reached $1.0 billion, growing 6%, while TMTT sales showed significant growth of 73%. The company reported Q3 EPS of $5.13 and adjusted EPS of $0.67. The quarter was marked by the completion of Critical Care divestiture and continued progress in PASCAL and EVOQUE commercial launches. Edwards maintained its full-year 2024 sales guidance ranges and expects Q4 sales between $1.33-$1.39 billion with EPS of $0.53-$0.57.
Edwards Lifesciences (NYSE: EW) has announced plans to release its Q3 2024 operating results on October 24, 2024, after market close. The company will host a conference call at 5:30 p.m. ET to discuss the results. Investors can participate by dialing (877) 704-2848 or (201) 389-0893. The call will also be available live and archived on the company's investor relations website.
Edwards Lifesciences is a global leader in patient-focused innovations for structural heart disease. The company is committed to improving lives through partnerships with clinicians and healthcare stakeholders worldwide.
Endotronix, an Edwards Lifesciences company (NYSE: EW), announced one-year clinical results from the PROACTIVE-HF trial for the Cordella Pulmonary Artery (PA) Sensor System at the Heart Failure Society of America Annual Scientific Meeting. The study of 456 patients showed a 49% lower rate of heart failure hospitalization and all-cause mortality compared to pre-specified expectations.
Secondary endpoints also demonstrated significant improvements:
- 10.5% in Kansas City Cardiomyopathy Questionnaire
- 13.3% in 6-minute walk test
- 36.2% in New York Heart Association classification
- 5.7% reduction in NT-proBNP levels
These results further validate the previously published 6-month data, supporting the efficacy of PA pressure-guided therapy in improving heart failure outcomes.
Edwards Lifesciences (NYSE: EW) has completed the sale of its Critical Care product group to BD (Becton, Dickinson and Company) for $4.2 billion in cash. The company plans to use the proceeds for strategic initiatives, including acquisitions and share repurchases. CEO Bernard Zovighian emphasized the company's sharpened focus on structural heart innovation, highlighting growth opportunities in TAVR, TMTT, and surgical leadership.
Edwards also announced an additional $1.5 billion authorization for share repurchase. The company has already initiated a $500 million Accelerated Share Repurchase agreement and previously repurchased $500 million of common stock. After this $1 billion share repurchase, Edwards will have $1.4 billion remaining for future repurchases.
Edwards Lifesciences (NYSE: EW) announced results from the RHEIA Trial, the first all-female study comparing transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR). The trial, involving 440 women with an average age of 73, showed superior outcomes for TAVI using Edwards SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA valves compared to SAVR.
Key findings at one-year follow-up:
- TAVI group: 8.9% experienced death, stroke, or rehospitalization
- SAVR group: 15.6% experienced death, stroke, or rehospitalization
The study, conducted across 48 sites in 12 European countries, aims to address the underrepresentation of women in aortic stenosis treatment research and provide insights into their specific treatment options.
Edwards Lifesciences (NYSE: EW) announced results from the RHEIA Trial, the first all-female study focused on transcatheter aortic valve implantation (TAVI) outcomes. The trial, presented at ESC Congress 2024, showed superior outcomes for women receiving Edwards SAPIEN 3 or SAPIEN 3 Ultra valves compared to surgical aortic valve replacement (SAVR).
Key findings include:
- TAVI was superior to SAVR in 1-year composite endpoints
- 8.9% of TAVI patients experienced death, stroke, or rehospitalization vs 15.6% in SAVR
- 443 female patients with an average age of 73 were included
- Study conducted across 48 sites in 12 European countries
The trial highlights the importance of valve selection for women, especially those with small annuli, to preserve options for future valve-in-valve procedures.
Edwards Lifesciences (NYSE: EW), a global leader in patient-focused innovations for structural heart disease and critical care monitoring, has announced its participation in the 2024 Wells Fargo Healthcare Conference. The event is scheduled for Thursday, September 5, 2024, with CEO Bernard Zovighian and CFO Scott Ullem set to present at 10:15 a.m. ET.
A live webcast of the presentation will be available on the company's investor relations website, with an archived version accessible later the same day. This presentation offers an opportunity for investors and stakeholders to gain insights into Edwards Lifesciences' strategies and market position in the healthcare industry.
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