Latest news with #EuroPCR2025
Yahoo
23-05-2025
- Health
- Yahoo
Edwards' study demonstrates value in early aortic stenosis intervention
New research by Edwards Lifesciences has demonstrated that early intervention for severe aortic stenosis (AS) before symptoms develop improves patient outcomes and reduces the economic and resource burden on healthcare systems. Edwards' real-world study of more than 24,000 patients with severe AS demonstrated that prompt intervention resulted in an average of 2.2 fewer days spent in hospitals during patients' treatment, 80% fewer heart failure hospitalisations one year after treatment, and cost reductions of $36,000 per patient at the one-year point. The study results were presented as a late-breaking clinical trial at EuroPCR 2025, taking place in Paris, France, between 20 and 23 May. Larry Wood, Edwards' corporate vice president and transcatheter aortic valve replacement (TAVR) and surgical group president, said: 'We are dedicated to advancing robust evidence to help improve outcomes for patients with severe AS. 'These latest findings underscore the importance of early referral to a heart valve team and timely care of patients with severe AS, reducing the economic and resource burden for hospitals.' It is no surprise that Edwards is shining a light on early AS intervention. The medtech giant recently received approval from the US Food and Drug Administration (FDA) on an indication expansion for its SAPIEN 3 TAVR platform in the treatment of patients with asymptomatic severe AS. The approval was supported by data from Edwards' EARLY TAVR trial (NCT03042104). The results demonstrated that asymptomatic severe AS patients randomised to the company's TAVR experienced superior outcomes versus guideline-recommended clinical surveillance (watchful waiting). At a median follow-up of 3.8 years, the data showed that 26.8% of the 455 patients in the trial's TAVR arm experienced death, stroke or unplanned cardiovascular hospitalisation versus 45.3% of the 446 patients in the clinical surveillance arm. According to GlobalData analysis, the global TAVR market is forecast to reach a valuation of around $13.7bn by 2033, up from $6.16bn in 2023. GlobalData's US Healthcare Facility Invoicing Database indicates that Edwards Lifesciences is currently the TAVR market leader, holding more than a 60% share of the US TAVR market. But change may be afoot. Medtronic recently released two-year results from a clinical trial comparing its Evolut system to Edwards' SAPIEN, with the data showing that the Evolut system led to significantly less bioprosthetic valve dysfunction, five times less prosthetic valve thrombosis, and nine times less haemodynamic structural valve dysfunction than the SAPIEN system. According to GlobalData analysis, the Evolut system could become the preferred option among healthcare professionals for patients with symptomatic severe AS and small aortic annulus categories, as evaluated in the trial. "Edwards' study demonstrates value in early aortic stenosis intervention" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
23-05-2025
- Health
- Yahoo
Edwards' study demonstrates value in early aortic stenosis intervention
New research by Edwards Lifesciences has demonstrated that early intervention for severe aortic stenosis (AS) before symptoms develop improves patient outcomes and reduces the economic and resource burden on healthcare systems. Edwards' real-world study of more than 24,000 patients with severe AS demonstrated that prompt intervention resulted in an average of 2.2 fewer days spent in hospitals during patients' treatment, 80% fewer heart failure hospitalisations one year after treatment, and cost reductions of $36,000 per patient at the one-year point. The study results were presented as a late-breaking clinical trial at EuroPCR 2025, taking place in Paris, France, between 20 and 23 May. Larry Wood, Edwards' corporate vice president and transcatheter aortic valve replacement (TAVR) and surgical group president, said: 'We are dedicated to advancing robust evidence to help improve outcomes for patients with severe AS. 'These latest findings underscore the importance of early referral to a heart valve team and timely care of patients with severe AS, reducing the economic and resource burden for hospitals.' It is no surprise that Edwards is shining a light on early AS intervention. The medtech giant recently received approval from the US Food and Drug Administration (FDA) on an indication expansion for its SAPIEN 3 TAVR platform in the treatment of patients with asymptomatic severe AS. The approval was supported by data from Edwards' EARLY TAVR trial (NCT03042104). The results demonstrated that asymptomatic severe AS patients randomised to the company's TAVR experienced superior outcomes versus guideline-recommended clinical surveillance (watchful waiting). At a median follow-up of 3.8 years, the data showed that 26.8% of the 455 patients in the trial's TAVR arm experienced death, stroke or unplanned cardiovascular hospitalisation versus 45.3% of the 446 patients in the clinical surveillance arm. According to GlobalData analysis, the global TAVR market is forecast to reach a valuation of around $13.7bn by 2033, up from $6.16bn in 2023. GlobalData's US Healthcare Facility Invoicing Database indicates that Edwards Lifesciences is currently the TAVR market leader, holding more than a 60% share of the US TAVR market. But change may be afoot. Medtronic recently released two-year results from a clinical trial comparing its Evolut system to Edwards' SAPIEN, with the data showing that the Evolut system led to significantly less bioprosthetic valve dysfunction, five times less prosthetic valve thrombosis, and nine times less haemodynamic structural valve dysfunction than the SAPIEN system. According to GlobalData analysis, the Evolut system could become the preferred option among healthcare professionals for patients with symptomatic severe AS and small aortic annulus categories, as evaluated in the trial. "Edwards' study demonstrates value in early aortic stenosis intervention" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-05-2025
- Business
- Yahoo
Edwards' New Late-Breaking Data on Severe AS Expected to Boost Stock
At the EuroPCR 2025, Edwards Lifesciences EW has announced new economic and clinical evidence on severe aortic stenosis (AS). The results of a new real-world study, comprising more than 24,000 patients, demonstrated that intervening on the disease before symptoms develop reduces the economic and resource burden on the healthcare system and improves patient outcomes. Presented as a late-breaking clinical trial, the data further contributes to the extensive body of research on this disease. The development is expected to boost both the company's Transcatheter Aortic Valve Replacement ('TAVR') and Surgical Structural Heart business units. Yesterday, Edwards shares finished the session at $74.79, down 1.7% from the previous close. On a promising note, the company has been committed to TAVR innovation and high-quality science that is increasing access to treatment options for all AS patients. Robust clinician adoption of the SAPIEN technology backs the segment's growth. In Surgical, Edwards continues to benefit from the strong uptake of the premium RESILIA portfolio, including INSPIRIS, MITRIS and KONECT. The company has been steadily advancing its top-tier surgical innovations around the world, solidifying its position. Hence, we expect that the market sentiment around EW stock will remain positive, driven by the latest news. Irvine, CA-based Edwards Lifesciences boasts a market capitalization of $44.64 billion. The company's earnings yield of 3.2% favorably compares to the industry's -2.8% yield. It has delivered an earnings beat of 3.5%, on average, in the trailing four quarters. The study revealed that prompt intervention for severe AS patients before symptoms developed has resulted in $36,000 less cost per patient for the healthcare system in one year. The length of hospital stay during treatment is shorter by 2.2 days, while follow-up heart failure hospitalizations one year after treatment also dropped by 80%. Additionally, compared with asymptomatic severe AS, delaying treatment until the disease progressed led to a more than seven times higher rate of death within one year after aortic valve replacement (AVR). Image Source: Zacks Investment Research Together with the previous data from the EARLY TAVR trial, these results have reinforced the value of early referral and evaluation by a Heart Valve Team for all patients with severe AS. Per a Market Research Future report, the AS treatment market is estimated at $8.6 billion in 2024 and projected to witness a compound annual growth rate (CAGR) of 7.4% by 2034. The market growth is highly driven by the advancements in medical technology, including minimally invasive procedures and breakthrough devices. Furthermore, the growing awareness among healthcare professionals and patients about treatment options is also leading to the market's expansion as more individuals seek early intervention for their conditions. This month, Edwards received FDA approval for its TAVR therapy, the SAPIEN 3 platform, meant for severe AS patients without symptoms. The approval is based on the groundbreaking data from the EARLY TAVR trial, which demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared to guideline-recommended clinical surveillance. In April, the company's SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. In the past six months, shares of EW have risen 5% against the industry's 11.8% fall. Edwards currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader medical space include Phibro Animal Health PAHC, Hims & Hers Health HIMS and Prestige Consumer Healthcare PBH. While Phibro Animal Health sports a Zacks Rank #1 (Strong Buy) at present, Hims & Hers Health and Prestige Consumer Health each carry a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here. Estimates for Phibro Animal Health's fiscal 2025 earnings per share have jumped 3.6% to $2.01 in the past 30 days. Shares of the company have rallied 24.1% in the past year compared with the industry's 8.6% growth. Its earnings yield of 8.7% compares comfortably with the industry's 0.5% yield. PAHC's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 30.6%. Hims & Hers Health shares have rallied 217.1% in the past year. Estimates for the company's 2025 earnings per share have jumped 12.5% to 72 cents in the past 30 days. HIMS' earnings beat estimates twice in the trailing four quarters, matched in one and missed on another occasion, the average surprise being 19.6%. In the last reported quarter, it posted an earnings surprise of 66.7%. Estimates for Prestige Consumer Healthcare'sfiscal 2026 earnings per share have increased 1 cent to $4.77 in the past 30 days. Shares of the company have jumped 36.8% in the past year compared with the industry's 10.8% growth. PBH's earnings surpassed estimates in three of the trailing four quarters and matched on one occasion, the average surprise being 2.8%. In the last reported quarter, it delivered an earnings surprise of 1.5%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Edwards Lifesciences Corporation (EW) : Free Stock Analysis Report Prestige Consumer Healthcare Inc. (PBH) : Free Stock Analysis Report Phibro Animal Health Corporation (PAHC) : Free Stock Analysis Report Hims & Hers Health, Inc. (HIMS) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Business Standard
22-05-2025
- Health
- Business Standard
Meril Presents Successful LANDMARK RCT One-Year Results at Prestigious EuroPCR 2025
PRNewswire Vapi (Gujarat) [India], May 22: Meril Life Sciences announced one-year results from its pivotal LANDMARK trial, presented during the prestigious Late-Breaking Trial session at EuroPCR 2025, one of the world's premier cardiology conferences held annually in Paris, France. The LANDMARK trial is the first randomized non-inferiority trial comparing the balloon-expandable Myval THV series with other contemporary balloon-expandable Sapien THV series and self-expandable Evolut THV series in patients with symptomatic severe aortic stenosis. The Myval THV series demonstrated non-inferiority to contemporary THVs in terms of 1-year clinical efficacy composite endpoint (Myval THV Series: 13% vs. Contemporary THV: 13.1%, difference: -0.1%, one-sided 95% CI: 3.9%, Pnoninferiority < 0.0001). Additionally, in the composite endpoint of clinical efficacy combined with QoL, outcomes were comparable (Myval THV Series: 19.5% vs. Contemporary THVs: 22.7%, difference: -3.2%, 95% CI: -9.2 to 2.9, P=0.33). Hemodynamic parameters including effective orifice area (EOA), mean pressure gradient (PG), and incidence of moderate or greater aortic regurgitation remained stable and similar across all treatment arms. Survival rates were nearly identical (Myval THV Series: 92.8% vs. Contemporary THVs: 92.9%), and QoL improvements were comparable, reinforcing the overall safety and durability of the Myval THV series in everyday clinical use. Professor Patri c k Serruys, Chairman and Study Director of the LANDMARK trial, said: "This trial reflects a new era in comparative valve research. The meticulous design and adherence to VARC-3 standards, including QoL endpoints, mark it as a pivotal study. The results of the LANDMARK trial represent a meaningful advancement for the global structural heart community--and most importantly, for patients receiving TAVI. The data not only validate the safety and efficacy of the Myval THV series, but also spotlight its adaptability to complex anatomies. This versatility is exactly what clinicians need to deliver precision care across a broad spectrum of patients." Professor Andreas Baumbach, Global Principal Investigat or, said: "The LANDMARK trial represents a significant step forward in TAVI research. For the first time, we've benchmarked Myval against both balloon-expandable and self-expanding platforms in a rigorous randomized setting. The one-year results demonstrates that the new generation Myval THV series can match global standards in safety and efficacy." Mr. Sanjeev Bhatt, Senior Vice President - Corporate Strategy at Meril, said: "The LANDMARK trial represents a significant milestone not just for Meril, but for the global TAVI community. The strong one-year results affirm the Myval THV series as a next-generation solution that delivers consistent safety, clinical efficacy, and improved quality of life across geographies. As the only head-to-head trial of its kind to include both balloon-expandable and self-expanding valves, it reinforces Myval THV series's versatility and real-world relevance for diverse patient anatomies and healthcare systems. At Meril, we are proud to contribute innovative, evidence-based technologies that are reshaping patient care and expanding access to advanced structural heart therapies worldwide." The trial is designed to follow patients for a period of 10 years, aiming to generate long-term insights into clinical and echocardiographic outcomes, with a focus on valve durability and sustained performance. About THE LANDMARK TRIAL: The LANDMARK trial is the first randomized non-inferiority trial comparing the balloon-expandable Myval THV series with other contemporary balloon-expandable Sapien THV series and self-expandable Evolut THV series in patients with symptomatic severe aortic stenosis. The LANDMARK trial was a prospective, randomized, multicenter, open-label, non-inferiority trial involving 768 patients who underwent Transcatheter Aortic Valve Implantation (TAVI) for the treatment of aortic stenosis. The first patient was enrolled in the LANDMARK trial on 6 January 2021 and the last patient was enrolled on 5 December 2023. The trial included a total of 768 patients at 31 sites across 16 countries (Brazil, New Zealand, and some countries of Europe). The 30-day primary composite endpoints highlighting the safety and efficacy outcomes of the LANDMARK trial have been successfully published in The Lancet and EuroIntervention, two of the most prestigious peer-reviewed medical journals. About Meril Life Sciences: Meril is a global medical device company based in India, committed to advancing healthcare through innovation. With a strong focus on research and development, Meril delivers cutting-edge medtech solutions across more than 135 countries and has a robust presence through subsidiaries in the USA, Brazil, Europe, Asia, Africa, and Australia. Through partnerships, precision technology, and adherence to international quality standards, Meril is helping reshape the future of healthcare. Media Contact: media@
Business Wire
22-05-2025
- Health
- Business Wire
Prompt Intervention for Severe Aortic Stenosis Patients Demonstrates Lower Healthcare Costs, Improved Clinical Outcomes
PARIS--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced new economic and clinical evidence on severe aortic stenosis (AS) presented as a late-breaking clinical trial at EuroPCR 2025, further contributing to the extensive body of research on this disease. The results of a new real-world study of more than 24,000 patients demonstrated that intervening on the disease before symptoms develop reduces the economic and resource burden on the healthcare system and improves patient outcomes. Prompt intervention for severe AS patients before symptoms developed resulted in: Significantly lower costs for the healthcare system at 1 year ($36,000 less per patient); Shorter length of stay during their treatment (2.2 fewer days); and Fewer follow-up heart failure hospitalizations 1 year after treatment (80 percent less). Additionally, compared with asymptomatic severe AS, delaying treatment until the disease progressed resulted in a more than seven times higher rate of death within one year after aortic valve replacement (AVR). 'We are dedicated to advancing robust evidence to help improve outcomes for patients with severe aortic stenosis,' said Larry Wood, Edwards' corporate vice president and group president, Transcatheter Aortic Valve Replacement and Surgical. 'These latest findings underscore the importance of early referral to a Heart Valve Team and timely care of patients with severe AS, reducing the economic and resource burden for hospitals.' Along with prior data from the EARLY TAVR trial, these results reinforce the value of early referral and evaluation by a Heart Valve Team for all patients with severe AS. 'We continue to believe that watchful waiting is not an effective strategy for the management of severe AS,' said Philippe Genereux, M.D., director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey. 'The latest findings highlight the significant clinical and economic advantages of timely referral and treatment for severe AS patients.' About Edwards Lifesciences Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at and follow us on LinkedIn, Facebook, Instagram and YouTube. This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this release to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as 'may,' 'might,' 'believe,' 'will,' 'expect,' 'project,' 'estimate,' 'should,' 'anticipate,' 'plan,' 'goal,' 'continue,' 'seek,' 'intend,' 'optimistic,' 'aspire,' 'confident' and other forms of these words and include, but are not limited to, statements made by Mr. Wood and statements regarding expected benefits of prompt intervention before symptoms develop, patient benefits and outcomes, reduction in economic and resource burdens for the healthcare system and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards, Edwards Lifesciences, the stylized E logo, and EARLY TAVR are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
