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Home » Topics » Medical devices » TAVR

TAVR
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AI-generated illustration of heart and metabolic impact

Pi-Cardia receives FDA greenlight for transcatheter leaflet splitter

Sep. 30, 2024
By Shani Alexander
The Pi-Cardia Ltd. Shortcut — the catheter-based, leaflet modification solution for treating heart valves — received U.S. FDA clearance. The device was granted breakthrough device designation from the regulatory agency and is designed to split bioprosthetic aortic valve leaflets in patients undergoing valve-in-valve transcatheter aortic valve replacement (TAVR) procedures who are at risk of coronary obstruction.
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Edwards-SAPIEN3-12-6.png

Edwards’ Sapien TAVR devices superior to SAVR in women

Sep. 6, 2024
By Annette Boyle
In the first study to compare transcatheter aortic valve replacement or implantation to surgical aortic valve replacement exclusively in women, Edwards Lifescience Corp.’s Sapien 3 and Sapien 3 Ultra valves provided better outcomes.
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Boston Scientific Acurate Prime Aortic Valve System

Boston Scientific’s Acurate Prime TAVR system gains CE mark

Sep. 3, 2024
By Annette Boyle
Boston Scientific Corp. obtained a CE mark for its latest self-expanding transcatheter aortic valve replacement technology, the Acurate Prime, opening up a new access point for increased sales and profitability in its structural heart division this year.
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Device in heart

Andera at the heart of growing appetite for cardiovascular devices

Aug. 20, 2024
By Shani Alexander
Andera Partners involvement in a string of recent deals in the cardiovascular space demonstrates the ongoing appetite for devices to treat heart diseases, Olivier Litzka, a partner at Andera Partners told BioWorld.
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Illustration of TAVR device

Edwards acquires TAVR system via JC Medical buy

Aug. 19, 2024
By Holland Johnson
Edwards Lifesciences Corp. continued its recent acquisition streak with its buy of JC Medical Inc., a subsidiary of Genesis Medtech International. The sale included the intellectual property and commercial rights for the J-Valve system, a transcatheter aortic valve replacement for the treatment of severe aortic regurgitation.
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British pound symbol

NICE: No evidence for price differentiation of transcatheter heart valves

Aug. 14, 2024
By Shani Alexander
There is no evidence to support the differences in prices that the U.K.’s national health service (NHS) is paying for transcatheter heart valves from Abbott Laboratories, Boston Scientific Corp., Edwards Lifesciences Corp. and Medtronic plc, according to the National Institute for Health and Care Excellence.
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Device in heart

Edwards offers SMART defense with data showing positive small annulus outcomes

June 6, 2024
By Holland Johnson
In what undoubtedly came as a response to Medtronic plc’s recently reported Small Annuli Randomized to Evolut or SAPIEN Trial trial results that showed a decisive advantage for its Evolut transcatheter aortic valve replacement system in patients with a small aortic annulus, Edwards Lifesciences Corp. reported the results from an analysis of data from its Placement of Aortic Transcatheter Valve trials of the Sapien 3 valves showing “excellent clinical outcomes and valve durability irrespective of the patient’s annulus size or sex.”
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Evolut device image

Get SMART: Medtronic’s Evolut TAVR outperforms Edwards Sapien in trial

April 9, 2024
By Holland Johnson
Medtronic plc reported data from a head-to-head trial backing its Evolut TAVR system against competitor Edwards Lifesciences Corp.’s Sapien platform, and the data showed particular promise of the Evolut in patients with a small aortic annulus, which would appear to be most beneficial for women in particular.
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4-9-Abbott-Triclip.png

Abbott wins approval for Triclip tricuspid valve repair system

April 2, 2024
By Holland Johnson
Abbott Laboratories reported the U.S. FDA approval of a new device specifically designed for the repair of leaky tricuspid heart valves. The Triclip was granted a PMA for the treatment of tricuspid regurgitation following the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of Triclip outweighed the risks.
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Illustration of TAVR device

Analysis of registry data hints minimally symptomatic patients are good candidates for TAVR

Sep. 21, 2023
By Mark McCarty

The annual volume of implant of transcatheter aortic valve replacement (TAVR) devices has grown steadily over the years, and that volume might sustain its upward trajectory over the next few years if the results of a new analysis of more than 46,000 TAVR patients gain traction. The data for these patients with minimally symptomatic aortic stenosis (AS) predictably indicated that this group was less susceptible to bad outcomes than those with more severe symptoms, but one of the hopes is that earlier intervention into AS could ward off future cardiovascular events, a finding which might justify expanded payer coverage for TAVR in these patient populations.


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