Tag: Edwards Lifesciences

Transcatheter tricuspid valve repair shows promise for reducing heart failure hospitalisations

In JACC: Heart Failure, Mathias Orban (Medizinische Klinik und Poliklinik I, Klinikum der Univer...

CE mark PASCAL clip-based system for transcatheter tricuspid repair

Edwards Lifesciences has received the CE mark for the PASCAL transcatheter valve repair system f...

COVID-19: Edwards pauses enrolment in mitral and tricuspid trials to allow hospitals to focus on virus

Edwards Lifesciences has temporarily paused new enrolments in its active pivotal clinical trials...

BIBA Briefings: Sapien 3 becomes first TAVI valve to be approved for low-risk patients in both Europe and the USA

Edwards Lifesciences has received the CE mark for its Sapien 3 transcatheter aortic valve implan...

ADVERTORIAL: Edwards PASCAL™ Transcatheter Valve Repair System is associated with a “striking” reduction in mitral regurgitation

This content is only for readers outside of the US as it discusses a device that is not FDA appr...

FDA approves Sapien 3 Ultra, Sapien 3, and CoreValve for low-risk TAVI

On 16 August, the US Food and Drug Administration (FDA) approved Edwards Lifesciences’ Sapien 3 ...

Edwards Lifesciences drops Centera in favour of focusing on Sapien range

Edwards Lifesciences—in a press statement announcing its global second quarter (Q2) financial re...

Edwards Lifesciences to discontinue its self-expanding valve Centera

Edwards Lifesciences has announced it has made the “difficult decision” to discontinue its self-...

Edwards Lifesciences issues urgent safety notice for Sapien 3 Ultra

Edwards Lifesciences has issued an urgent safety notice for the latest generation of its Sapien ...

Edwards Lifesciences issues an urgent field safety notice for Centera TAVI system

After receiving reports of difficulty tracking and manipulating the Centera transcatheter aortic...

TVT 2019: PASCAL system may be beneficial for managing tricuspid regurgitation

New data for the PASCAL system (Edwards Lifesciences), which received the CE mark in February 2019 f...
pascal repair

ADVERTORIAL: Edwards PASCAL™ Transcatheter Valve Repair System is innovative

This content is only for readers outside of the US as it discusses a device that is not FDA appr...

ACC 2019: TAVI moves to the mainstream with new findings in low-risk patients

Evidence for the use of transcatheter aortic valve replacement (TAVI) as standard therapy is mountin...

Sapien 3 provides safe and satisfactory access via the transcarotid route

The Sapien 3 device (Edwards Lifesciences) can be safely and effectively used in transcatheter a...

ADVERTORIAL: The Edwards Cardioband™ Tricuspid Valve Reconstruction System is associated with considerable improvement in functional outcomes

This content is only for readers outside of the US as it discusses a device that is not FDA appr...

CE mark for PASCAL mitral valve repair system

Edwards Lifesciences now has the CE mark for its PASCAL transcatheter mitral valve repair system. Ac...

Boston Scientific, Edwards Lifesciences agree to global litigation settlement

Boston Scientific and Edwards Lifesciences today announced that the companies have reached an agreem...

Sapien 3 Ultra receives FDA approval

It has been announced that the Sapien 3 Ultra system (Edwards Lifesciences) has received US FDA ...

US District Court for the District of Delaware rules that Sapien 3 infringes a Boston Scientific patent

A jury in the US District Court for the District of Delaware determined that the Boston Scientif...

Edwards Lifesciences to collaborate with Bay Labs to use AI software to improve detection of heart disease

Edwards Lifesciences is to work with Bay Labs on improving the detection of heart disease. The p...

First implant of Pascal transcatheter mitral valve repair device performed in CLASP IID trial

The first implant of the Pascal mitral valve repair device (Edwards Lifesciences) in the CLASP IID p...

Launch of Sapien 3 Ultra hampered by Boston Scientific dispute

The CE mark has been granted to the Sapien 3 Ultra (Edwards Lifesciences) transcatheter aortic v...

US trial of Edwards’ self-expanding Centera valve begins

Edwards Lifesciences has commenced the US pivotal trial that will study its self-expanding Cente...

Boston Scientific successfully opposes Edwards Lifesciences Corporation’s European patent EP 2,399,550 (550)

According to a press release, Boston Scientific has, along with several other opponents, success...

Enrolment complete in CT imaging substudy of leaflet mobility with Sapien 3 in low-risk patients

Edwards Lifesciences has announced that enrolment is complete in the computed tomography (CT) im...

UK Court of Appeal dismisses Edwards Lifesciences’ appeal against Sapien 3 infringement ruling

Acurate neo Boston Scientific has announced the UK Court of Appeal  dismissed Edwards Lifesc...

Edwards’ self-expanding Centera TAVI valve now on European market

Edwards Lifesciences has received the CE mark for its self-expanding Centera transcatheter aortic va...
Edwards Lifesciences acquires Harpoon Medical

Harpoon Medical acquired by Edwards

Edwards Lifesciences Corporation today announced it has acquired Harpoon Medical, Inc., following it...

TCT 2017: TMVI in mitral ring is a reasonable alternative for high-risk patients

Data from the MITRAL (Mitral Implantation of Transcatheter valves) study indicate that transepta...

Edwards Lifesciences’ Alterra adaptive prestent device used for first time to treat a malformed pulmonary valve

Evan Zahn (Guerin Family Congenital Heart Program, Cedars-Sinai Heart Institute, Los Angeles, USA) h...

FDA approve “first-in-class” resilient surgical valve

Edwards Lifesciences has FDA approval for its Inspiris Resilia surgical aortic valve, which a pr...

German court awards Edwards Lifesciences co-entitlement of Neovasc’s Tiara patent application

The District Court in Munich, Germany has partially found in favour of Edwards Lifesciences Corp...

First procedures using Edward Lifesciences’ Inspiris Resilia aortic valve take place

The first ever Inspiris Resilia aortic valve (Edwards Lifesciences) implantation procedures have...

EuroPCR 2017: Excellent early outcomes for Edwards Lifesciences’ self-expanding valve

According to late-breaking trial presented at EuroPCR (16–19 May, Paris, France), a novel self-e...

ACC 2017: Embol-X and CardioGard do not reduce number of brain lesions, but may affect lesion size

Two US Food and Drug Administration-cleared medical devices designed to remove potential vessel-bloc...

Edwards Lifesciences halts enrolment in Cardiaq trial

According to a SeekingAlpha transcript of an Edwards Lifesciences fourth-quarter 2016 earnings c...

Edwards Lifesciences completes acquisition of Valtech Cardio

Edwards Lifesciences has closed its previously announced acquisition of Valtech Cardio, develope...

Edward Lifesciences to acquire Valtech

Valtech Cardio has agreed to be acquired by Edwards Lifesciences. The acquisition will give Edwa...

TCT 2016: Transfemoral TAVI improves quality of life in intermediate-risk patients

Data presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2...

London Valves 2016: Edwards announces SAPIEN 3™ valve CE Mark approved for intermediate-risk patients

PCR London Valves 2016 opened in the main arena with the Edwards Lifesciences TNT session "TAVI ...

New “resilient” surgical aortic valve now available in Europe

Edwards Lifesciences has received the CE mark for its Inspiris Resilia aortic valve, which is th...

Sapien 3 now approved for intermediate-risk patients in Europe as well as in the USA

Following last month’s FDA approval for the expanded indication of Sapien 3 for the treatment of...

FDA approval for Edwards Intuity Elite rapid deployment valve

Edwards Lifesciences has received FDA approval for its advanced Intuity Elite rapid deployment valve...

Edwards Sapien 3 granted expanded indication from US FDA

Edwards Lifesciences has announced US Food and Drug Administration (FDA) approval to expand use ...