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BioWorld - Tuesday, July 14, 2026
Home » Keywords » transcatheter aortic valve replacement

Items Tagged with 'transcatheter aortic valve replacement'

ARTICLES

Med-tech companies slapped with historic FTC penalty

July 14, 2026
By Mari Serebrov
No Comments
Edwards Lifesciences Corp. and Genesis Medtech Group Ltd. will pay a total of $12 million in penalties as part of a U.S. FTC settlement resolving allegations that they intentionally structured a deal in which Edwards acquired Genesis’ JC Medical to avoid complying with the notification and waiting period requirements of the Hart-Scott-Rodino Act.
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Biosensors International Allegra transcatheter heart valve
EuroPCR 2026

All Women data show Allegra edge in female TAVR patients

May 20, 2026
By Shani Alexander
No Comments
Data from the All Women clinical trial, which looked at the Allegra transcatheter aortic valve replacement (TAVR) system compared to balloon-expandable valves (BEV) in women with aortic stenosis, showed that Allegra delivered lower mean gradients and less prosthesis-patient mismatch than BEVs. The data presented at the EuroPCR conference in Paris was the first randomized head-to-head comparison of different TAVR platforms conducted exclusively in women.
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Mirus Siegel TAVR

Boston Sci invests $1.5B in Mirus, gains option for TAVR system

May 18, 2026
No Comments
Boston Scientific Corp. has invested $1.5 billion for a 34% equity stake in Mirus LLC in a deal under which it is also gaining an exclusive option to acquire the Siegel balloon expandable transcatheter aortic valve replacement (TAVR) system.
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Edwards Lifesciences Sapien M3

Edwards raises 2026 guidance on strong TAVR performance

April 24, 2026
By Shani Alexander
No Comments
Edwards Lifesciences Corp. raised its full-year 2026 guidance after seeing strong sales in the first quarter, particulalry from its transcatheter aortic valve replacement (TAVR) business. The company now expects sales growth of 9% to 11%, up from prior outlook of 8% to 10%, and adjusted earnings per share of $2.95 to $3.05, compared with earlier guidance of $2.90 to $3.05.
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Anteris Duravr

Medtronic pumps $90M into Anteris TAVR program

Jan. 28, 2026
By Annette Boyle
Medtronic plc acted on the increase in M&A and expansion of its investment ecosystem touted at the J.P. Morgan Healthcare Conference earlier this month with a $90 million infusion into Brisbane, Australia-based Anteris Technologies Global Corp. The investment had been contingent on a public offering of stock by Anteris, which it completed on Jan. 22. Together, the new funds for the biomimetic heart valve company totaled $320 million.
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White puzzle pieces on blue background

Edwards scraps Jenavalve buy in face of FTC objections

Jan. 12, 2026
By Holland Johnson
Edwards Lifesciences Corp. said it is scrapping plans to acquire Jenavalve Technology Inc. for $945 million after a federal court ruled against the company in a case brought by the U.S. Federal Trade Commission (FTC) to block the deal.
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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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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 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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Device in heart

Edwards bullish on TAVR, long-term growth at investor day

Dec. 10, 2024
By Holland Johnson
At its investor day conference, Edwards Lifesciences Corp. prognosticated that an expanded indication in transcatheter aortic valve replacement and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.
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