Latest news with #SAPIEN
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
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
Associated Press
09-03-2025
- Health
- Associated Press
SMART Trial two-year data continues to demonstrate superior valve performance for Evolut TAVR™ system in small annulus patients
CRT 2025 Late Breaking Science features largest head-to-head randomized control TAVR trial to primarily enroll women using the two most widely used global TAVR devices GALWAY, Ireland and WASHINGTON, March 9, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today released the two-year results of the SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial, the largest international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (TAVR). In patients with aortic stenosis and a small aortic annulus, results showed comparable composite outcome of mortality, disabling stroke, and heart failure hospitalization, and continued superior valve performance as measured by bioprosthetic valve dysfunction (BVD) at two years for Evolut™ TAVR compared to SAPIEN™. The late-breaking science was presented at the Cardiovascular Research Technologies (CRT) 2025 conference in Washington, D.C. 'Valve performance is critical for all patients, but the impact of poor valve performance is magnified in patients with a small aortic annulus, who are at risk of receiving a valve that is not adequate for their cardiac requirements,' said Howard C. Herrmann, M.D., Perelman School of Medicine at the University of Pennsylvania, and lead investigator of the trial. 'The two-year results highlight the continued superior performance of the Evolut TAVR valve in these patients. While we would not yet expect to see a significant difference in the composite clinical outcomes at this early stage, valve performance provides important data that operators can use to inform and personalize treatment decisions to enhance patient outcomes.' The SMART two-year data demonstrated that Evolut TAVR continues to show significantly less BVD, which can be a predictor of adverse outcomes1, compared to SAPIEN TAVR. Additional results demonstrated that Evolut TAVR showed the following relative to SAPIEN TAVR: Five times less prosthetic valve thrombosis (p=0.0048) Nine times less hemodynamic structural valve dysfunction (defined by mean gradient ≥ 20mmHg; p<0.001) These results build on additional data of Evolut BVD performance in small and large annulus patients, which will be presented as a late-breaker at CRT today, and the Evolut BVD pooled analysis by Dr. Steven Yakobuv published in the Journal of the American College of Cardiology. The SMART Trial is an international, prospective, multi-center, randomized (1:1) post-market trial comparing the safety and performance of Evolut self-expanding TAVR versus SAPIEN balloon-expandable TAVR in patients with symptomatic severe aortic stenosis (AS) and small aortic annulus. The trial, the largest head to head randomized control trial to primarily enroll women, randomized and treated 716 patients, 87% of which were women, across more than 80 sites worldwide.2 Eligible patients had an aortic valve annulus area of ≤430 mm as measured by computed tomography, and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a SAPIEN 3™/3 Ultra™ valve. Patients enrolled in the trial will continue to be followed out to five years. 'The SMART Trial is a groundbreaking, head-to-head comparison that, for the first time, highlights how a patient with a small annulus can benefit from Evolut's differentiated valve design,' said Kendra J. Grubb, M.D., M.H.A, vice president and chief medical officer, Structural Heart, which is part of the Cardiovascular Portfolio at Medtronic. 'At two years, we continue to see superior valve performance that we will follow to assess long-term outcomes.' About Aortic Stenosis Aortic stenosis (AS), a narrowing of the aortic valve, is among the most common of all valvular heart diseases, impacting 1.5 million in the U.S.3 Symptomatic severe AS can be fatal if left untreated and the average patient survival is two years without treatment.4 Approximately 40% of the total global market is believed to have a small aortic annulus, requiring tailored valve selection for their unique anatomy. About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit and follow @Medtronic on LinkedIn. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. 1Généreux, P. et al. J Am Coll Cardiol. 2021;77(21):2717-46 2Herrmann HC, Mehran R, Blackman DJ, Bailey S, Mollmann H, et al. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971. 3Carabello BA, Paulus WJ. Aortic stenosis. Lancet. March 14, 2009;373(9667):956-966. 4Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. April 1998;113(4):1109-1114. Contact: Ryan Weispfenning Kimberly Powell Public Relations
