Edwards Lifesciences Corp - EW STOCK NEWS

Edwards Lifesciences (NYSE: EW) announced one-year data showing exceptional performance of its SAPIEN 3 Ultra RESILIA valve. Analysis of over 9,000 propensity-matched patients revealed superior outcomes compared to earlier valve generations, with extremely low mortality, low reintervention rates, and no paravalvular leak in 84.4% of cases. Patients experienced significant quality of life improvements with an average 31-point increase in KCCQ score and brief one-day hospital stays, with 93% discharged home. The study population had an average STS score of 3.6 and average age of 77.

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.