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BioWorld - Monday, December 29, 2025
Home » Keywords » Sapien 3

Items Tagged with 'Sapien 3'

ARTICLES

Edwards SAPIEN 3 transcatheter heart valve

Edwards shows benefits of early TAVR in asymptomatic severe AS

Nov. 26, 2025
By Shani Alexander
Edwards Lifesciences Corp. released data from a health economics study done across nine countries in Europe which showed that early transcatheter aortic valve replacement in patients with asymptomatic severe aortic stenosis can deliver significant economic benefits alongside improved clinical outcomes.
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Device in heart

FDA expands Edwards’ TAVR to asymptomatic severe aortic stenosis

May 1, 2025
By Annette Boyle
In a significant boost to the Edwards Lifesciences Corp. Sapien 3 platform’s market opportunity, the U.S. FDA approved use of the transcatheter aortic valve replacement in patients with asymptomatic aortic stenosis.
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3D rendering of heart, mitral valve

Medtronic receives CE mark for heart valve replacement system

Jan. 7, 2025
By Shani Alexander
Medtronic plc received CE mark approval for its Harmony transcatheter pulmonary valve system to treat congenital heart disease patients with native or surgically repaired right ventricular outflow tract pulmonary regurgitation.
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Device in heart

Edwards reveals superior outcomes with Sapien 3 Ultra Resilia

Nov. 25, 2024
By Shani Alexander
Edwards Lifesciences Corp. revealed excellent one-year data highlighting the performance of its newest generation Sapien 3 Ultra Resilia valve. Patients treated with the transcatheter aortic valve replacement system experienced lower rates of mortality and reintervention compared to its predecessors.
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Shockwave IVL

All-female trials in CVD recognize structural differences

Nov. 1, 2024
By Annette Boyle
Two recent trials in cardiovascular disease took critical steps toward addressing ongoing and deadly disparities in cardiac care by focusing entirely on women.
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Device in heart

Edwards scores big at TCT with EARLY TAVR study

Oct. 28, 2024
By Mark McCarty
Transcatheter aortic valve replacement (TAVR) devices continue to make a splash in the world of medical technology, with the Sapien 3 by Edwards Lifesciences Corp. leading the way. Results of the EARLY TAVR study strongly suggest a need for implant in asymptomatic patients with severe aortic stenosis, a development that should help sustain and possibly increase sales of these devices for the next few years.
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Device in heart

CRT 2024: Strong results for TAVR across risk groups

March 12, 2024
By Annette Boyle
The Cardiovascular Research Technologies 2024 conference in Washington this week demonstrated continued positive outcomes for patients who underwent transcatheter aortic valve replacement with devices made by Abbott Laboratories, Edwards Lifesciences Corp. or Medtronic plc.
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Digital 3d heart model showing FFR values along coronary arteries
TCT Connect 2020

FFR processing fails to blunt costs in U.K. study of patients with stable angina

Oct. 16, 2020
By Mark McCarty
Fractional flow reserve (FFR) processing of computed tomography (CT) images has gained a substantial body of momentum over the past few years, but a recent study posed the question of whether it can save health care systems from excess spending for stable angina.
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Product image
TCT Connect 2020

Clinicians not ready to throw dirt on Acurate Neo despite clinical trial failure

Oct. 16, 2020
By Mark McCarty
The history of TAVR devices is evolutionary as much as it is revolutionary, or that is at least the take-away from an Oct. 15 virtual session comparing the Acurate Neo device by Boston Scientific Corp., of Marlborough, Mass., with the Corevalve Evolut R by Dublin-based Medtronic plc.
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Device in heart

Edwards exceeds Wall Street expectations in Q2, in spite of COVID-19

July 24, 2020
By Meg Bryant
Edwards Lifesciences Corp. reported better-than-expected results when it released its second quarter earnings late July 23, with revenue down 15% to $924 million, from $1.1 billion in the same period of 2019. The results beat Wall Street consensus of $797.5 million, and reflected an uptick in surgical procedures that had been delayed by the COVID-19 pandemic. The Irvine, Calif.-based company sustained a net loss of $121.9 million, or $0.20 per share, based on generally accepted accounting principles (GAAP), a sharp drop from $242.3 million, or $0.38 per share, in the same quarter last year. However, adjusted earnings looked brighter at $0.34 per share.
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