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BioWorld - Saturday, December 13, 2025
Home » Topics » Medical devices » TAVR

TAVR
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Device in heart

Edwards Lifesciences celebrates new ESC guidelines

Aug. 29, 2025
By Annette Boyle
Edwards Lifesciences Corp. execs no doubt danced a little jig on the release of the latest European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines for valvular heart disease. The update established a simplified pathway for severe aortic stenosis (AS) that eliminated the previous divide between symptomatic and asymptomatic severe AS.
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Evolut device image

FDA approves Medtronic Evolut for expanded redo TAVR indication

Aug. 28, 2025
By Annette Boyle
Medtronic plc received U.S. FDA approval for the expanded redo TAVR indication of the Evolut transcatheter aortic valve replacement system. The approval allows for valve-in-valve implantation of a new Evolut valve inside a failed previously implanted TAV made by any manufacturer in patients with severe aortic stenosis considered high-risk for open-heart surgery.
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Boston Scientific Acurate Prime Aortic Valve System

In TAVR setback, Boston Sci pulls plug on Acurate valves

May 28, 2025
By Holland Johnson
Boston Scientific Corp. reported the latest setback in its transcatheter aortic valve replacement (TAVR) aspirations with the news that it is officially discontinuing worldwide sales of its Acurate neo2 and Acurate Prime systems
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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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Boston Scientific Sentinel
AAC25

No benefit found for cerebral protection device in TAVR

April 2, 2025
By Annette Boyle
Counterintuitively, use of cerebral embolic protection failed to reduce the incidence of stroke in the 72 hours following a transcatheter aortic valve replacement or implantation found a late-breaking clinical trial presented at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago and simultaneously published in the New England Journal of Medicine.
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Edwards-SAPIEN3-12-6.png

Edwards’ Early TAVR refutes surveillance recs for aortic stenosis

April 1, 2025
By Annette Boyle
Don’t wait. Edwards Lifesciences Corp.’s additional insights from the Early TAVR trial showed a clear benefit for transcatheter aortic valve replacement (TAVR) in patients with asymptomatic aortic stenosis.
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Evolut device image
ACC.25

At 5 years, TAVR as good as SAVR in low-risk patients

March 31, 2025
By Annette Boyle
Medtronic plc’s Evolut Low-Risk trial continued to show non-inferiority of transcatheter aortic valve replacement to surgical aortic valve replacement in terms of death or disabling stroke at five years in a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session in Chicago on March 30.
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Evolut device image

Medtronic sees SMART TAVR results in small aortic annulus patients

March 10, 2025
By Holland Johnson
Medtronic plc released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli.
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Device in heart

Edwards: TAVR wavers, mitral valve shines

Feb. 12, 2025
By Annette Boyle
Edwards Lifesciences Corp.’s posted fourth quarter results slightly ahead of expectations, but indicated that the first quarter of 2025 might not be as bright. The company expects growth for both its lead transcatheter aortic valve replacement (TAVR) business and the company to fall below its full-year estimates, with a mid-year indication expansion for TAVR providing a critical boost in the back half of 2025.
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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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