Tag: Sapien 3

ACC 2019: TAVI moves to the mainstream with new findings in...

Evidence for the use of transcatheter aortic valve replacement (TAVI) as standard therapy is mounting, with the release of data from two major new...

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 aortic valve implantation (TAVI) via the transcarotid approach in patients...

Sapien 3 Ultra receives FDA approval

It has been announced that the Sapien 3 Ultra system (Edwards Lifesciences) has received US FDA approval for transcatheter aortic valve implantation (TAVI) in...

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 patient outcomes for patients undergoing transcatheter aortic valve implantation (TAVI) with...

TMVI in inoperable patients is feasible but mortality high at one...

One-year outcome data for transcatheter mitral valve implantation (TMVI), in inoperable patients, indicate most patients who survive the first 30 days after the procedure...

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

According to a press release, Boston Scientific has, along with several other opponents, successfully opposed Edwards Lifesciences Corporation's European patent EP 2,399,550 (550) in...

Enrolment complete in CT imaging substudy of leaflet mobility with Sapien...

Edwards Lifesciences has announced that enrolment is complete in the computed tomography (CT) imaging substudy within the PARTNER 3 trial of the Sapien 3...

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

Acurate neo Boston Scientific has announced the UK Court of Appeal  dismissed Edwards Lifesciences’ appeal and upheld a prior court decision that Edwards’...

TCT 2017: TMVI in mitral ring is a reasonable alternative for...

Data from the MITRAL (Mitral Implantation of Transcatheter valves) study indicate that transeptal transcatheter mitral valve implantation (TMVI), with a Sapien 3 device (Edwards...

TCT 2017: TAVI “should be the preferred strategy” for patients at...

David Cohen (Saint Luke’s Mid America Heart Institute, Kansas City, USA) has suggested that, on basis of both clinical and economic considerations, transcatheter aortic...

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 mitral valve-in-valve procedures using the Edwards Sapien 3 transcatheter heart...

UK Patents Court makes initial decision on Edwards Sapien 3 and...

The Patents Court in the UK has determined that one of Boston Scientific’s patents related to outer seals for transcatheter heart valves that was...

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 November, Washington, DC, USA) indicate that intermediate-risk patients who undergo transcatheter aortic...

London Valves 2016: Edwards announces SAPIEN 3™ valve CE Mark approved...

PCR London Valves 2016 opened in the main arena with the Edwards Lifesciences TNT session "TAVI in 2016: the year the treatment of aortic...

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

Following last month’s FDA approval for the expanded indication of Sapien 3 for the treatment of intermediate-risk patients with aortic stenosis, the device can...

Edwards Sapien 3 granted expanded indication from US FDA

Edwards Lifesciences has announced US Food and Drug Administration (FDA) approval to expand use of the Edwards Sapien 3 transcatheter heart valve for the...

TAVI with Sapien 3 may be better than surgery for intermediate-risk...

A ccording to Vinod H Thourani (Emory University School of Medicine, Atlanta, USA) and others, intermediate-risk patients undergoing transcatheter aortic valve implantation (TAVI) with the...