Latest news with #EARLYTAVR
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
Medscape
08-05-2025
- Health
- Medscape
FDA Approves TAVR in Asymptomatic Severe Stenosis
A transcatheter aortic valve replacement (TAVR) therapy was approved by the US Food and Drug Administration (FDA) for patients with severe aortic stenosis even without symptoms. This is the first FDA approval for TAVR in patients who are asymptomatic. Current clinical guidelines recommend routine surveillance every 6-12 months in patients who aren't having any symptoms. The agency's decision to approve the balloon-expandable SAPIEN 3 platform (Edwards Lifesciences) is based on results from the EARLY TAVR trial, which demonstrated that patients with asymptomatic severe aortic stenosis randomized to early intervention had superior outcomes than those under guideline-recommended clinical surveillance. The EARLY TAVR trial was published in The New England Journal of Medicine . 'The world has been waiting for the results of this trial,' Bernard Prendergast, DM, chair of Cardiology at the Cleveland Clinic London and consultant cardiologist at St Thomas' Hospital, both in London, England, said when the trial findings were presented in October at the Transcatheter Cardiovascular Therapeutics (TCT) 2024. Prendergast was one of several cardiologists who described the EARLY TAVR trial as a landmark study, and he called the results 'a major reset in our approach to severe aortic stenosis.' Early TAVR 'There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis, which currently recommend 'watchful waiting' until symptoms develop,' said Philippe Généreux, MD, director of the Structural Heart Program at Gagnon Cardiovascular Institute, Morristown Medical Center in Morristown, New Jersey. 'As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation.' Presenting a post hoc analysis of EARLY TAVR at the Society for Cardiovascular Angiography and Interventions Scientific Sessions in Washington, DC, Généreux showed benefits for unplanned hospitalization, stroke, and all-cause death, combined and separately, during follow-up in 901 patients, averaging 3.8 years. A total of 122 patients receiving early TAVR (26.8%) and 202 patients under clinical surveillance (45.3%) had any one of the outcomes — a significant difference. Of those undergoing TAVR, 8.4% died vs 9.2% of those under clinical surveillance. Stroke affected 4.2% of those undergoing early TAVR and 6.7% of those under clinical surveillance, and the rate of unplanned hospitalization for cardiovascular causes was 20.9% in the early TAVR group and 41.7% in the clinical surveillance group. In fact, 87% of patients in the clinical surveillance group eventually had to undergo aortic valve replacement during the follow-up period. The benefits of early TAVR were consistent across age groups, reported Généreux. However, the early TAVR results were particularly striking for specific outcomes in some age groups. For example, TAVR resulted in much lower rates of death, stroke, or hospitalization for heart failure in patients aged 65-69 years. There were also no strokes in this age group. Stroke rates were also significantly lower in patients aged 80 years or older undergoing early TAVR. Hospitalization for heart failure was significantly lower in patients aged 70 years or older undergoing early TAVR. 'The results are important and highlight the benefits of early intervention among younger patients with asymptomatic severe aortic stenosis, especially in regard to stroke risk, a complication which is the most feared by patients,' said Généreux. 'We are discovering that aortic stenosis itself might be an important risk factor for stroke, if left untreated,' he added.
Business Wire
01-05-2025
- Health
- Business Wire
Edwards TAVR Receives FDA Approval for Patients With Asymptomatic Severe Aortic Stenosis
IRVINE, Calif.--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients. Approval of the SAPIEN 3 platform (SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA) is based on 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 (watchful waiting). Without treatment, 1 in 10 patients experiencing symptoms of severe AS may die within five weeks. However, the symptoms of severe AS can be difficult to detect and may progress rapidly and unpredictably. 'There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend 'watchful waiting' until symptoms develop,' said Philippe Genereux, M.D., director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey. 'As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team to improve patient outcomes and benefit the healthcare system.' The EARLY TAVR trial was the first randomized, controlled trial designed to evaluate TAVR compared to watchful waiting for patients with asymptomatic severe AS. With a median follow-up of 3.8 years, 26.8% of the 455 patients in the TAVR arm experienced death, stroke, or unplanned cardiovascular hospitalization, compared with 45.3% of the 446 patients in the clinical surveillance arm. The data were published last year in The New England Journal of Medicine (NEJM), marking the ninth NEJM publication on Edwards TAVR. "This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,' said Larry Wood, Edwards' corporate vice president and group president, Transcatheter Aortic Valve Replacement and Surgical. 'We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.' Since its introduction more than two decades ago, SAPIEN has become the most studied valve platform, demonstrating unmatched clinical outcomes and solidifying its position as the leading choice for physicians and patients. More than 1 million patients have been treated with SAPIEN valves worldwide. 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 product benefits, optimization of treatment pathways, clinical outcomes, objectives, leading position, 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, EARLY TAVR, RESILIA, SAPIEN, SAPIEN 3 and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
Associated Press
01-05-2025
- Health
- Associated Press
Edwards TAVR Receives FDA Approval for Patients With Asymptomatic Severe Aortic Stenosis
IRVINE, Calif.--(BUSINESS WIRE)--May 1, 2025-- Edwards Lifesciences (NYSE: EW) announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients. Approval of the SAPIEN 3 platform (SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA) is based on 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 (watchful waiting). Without treatment, 1 in 10 patients experiencing symptoms of severe AS may die within five weeks. However, the symptoms of severe AS can be difficult to detect and may progress rapidly and unpredictably. 'There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend 'watchful waiting' until symptoms develop,' said Philippe Genereux, M.D., director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey. 'As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team to improve patient outcomes and benefit the healthcare system.' The EARLY TAVR trial was the first randomized, controlled trial designed to evaluate TAVR compared to watchful waiting for patients with asymptomatic severe AS. With a median follow-up of 3.8 years, 26.8% of the 455 patients in the TAVR arm experienced death, stroke, or unplanned cardiovascular hospitalization, compared with 45.3% of the 446 patients in the clinical surveillance arm. The data were published last year in TheNew England Journal of Medicine (NEJM), marking the ninth NEJM publication on Edwards TAVR. 'This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,' said Larry Wood, Edwards' corporate vice president and group president, Transcatheter Aortic Valve Replacement and Surgical. 'We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.' Since its introduction more than two decades ago, SAPIEN has become the most studied valve platform, demonstrating unmatched clinical outcomes and solidifying its position as the leading choice for physicians and patients. More than 1 million patients have been treated with SAPIEN valves worldwide. 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 product benefits, optimization of treatment pathways, clinical outcomes, objectives, leading position, 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, EARLY TAVR, RESILIA, SAPIEN, SAPIEN 3 and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. View source version on CONTACT: Media Contact: Heather Bukant, 949-250-2753 Investor Contact: Mark Wilterding, 949-250-6826 KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICAL DEVICES HEALTH CLINICAL TRIALS HEALTH TECHNOLOGY SOURCE: Edwards Lifesciences Corporation Copyright Business Wire 2025. PUB: 05/01/2025 08:00 AM/DISC: 05/01/2025 07:59 AM
