Tag: Sapien 3
Edwards’ Sapien 3 lands US FDA approval for the treatment of asymptomatic severe AS
Edwards Lifesciences has announced that the US Food and Drug Administration (FDA) has approved i...
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...
TCT 2019: Acurate neo does not meet non-inferiority compared to Sapien 3
The first randomised trial to compare the safety and efficacy of the Acurate neo transcatheter h...
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 to discontinue its self-expanding valve Centera
Edwards Lifesciences has announced it has made the “difficult decision” to discontinue its self-...
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...
Sapien 3 Ultra receives FDA approval
It has been announced that the Sapien 3 Ultra system (Edwards Lifesciences) has received US FDA ...
EuroPCR 2018: Real-world data confirm trial outcomes for Sapien 3
Thirty-day data presented at EuroPCR (22 May—25 May, Paris, France) show consistently positive p...
TMVI in inoperable patients is feasible but mortality high at one year
One-year outcome data for transcatheter mitral valve implantation (TMVI), in inoperable patients...
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...
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...
TCT 2017: TAVI “should be the preferred strategy” for patients at intermediate-risk
David Cohen (Saint Luke’s Mid America Heart Institute, Kansas City, USA) has suggested that, on ...
Sapien 3 receives expanded FDA indication for valve-in-valve procedures
Edwards Lifesciences has received US Food and Drug Administration (FDA) approval for aortic and ...
UK Patents Court makes initial decision on Edwards Sapien 3 and Boston Scientific’s patents
The Patents Court in the UK has determined that one of Boston Scientific’s patents related to ou...
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 ...
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...
Edwards Sapien 3 granted expanded indication from US FDA
Edwards Lifesciences has announced US Food and Drug Administration (FDA) approval to expand use ...
TAVI with Sapien 3 may be better than surgery for intermediate-risk patients
A
ccording to Vinod H Thourani (Emory University School of Medicine, Atlanta, USA...
