Feature | January 28, 2014

Edwards Sapien 3 Valve Approved in Europe

Sapien 3, TAVR, CE mark, european approval
January 28, 2014 — Edwards Lifesciences Corp. received CE marking for its Edwards Sapien 3 transcatheter aortic valve.
 
The Sapien 3 valve has an outer skirt providing a seal to address paravalvular leak and can be delivered through a low-profile 14 French expandable sheath (eSheath), which has shown through early clinical experience a low rate of complications. The valve can be implanted through multiple approaches: transfemoral, transapical or transaortic. Once implanted, the discreet valve anchors in the aortic annulus.
 
In the United States, the Edwards Sapien 3 valve is an investigational device being studied in the PARTNER II Trial and is not yet available for sale in the country.
 
For more information: www.edwards.com
 

Related Content

Mitralign, Series E funding, Trialign, MPAS
News | Heart Valve Technology| May 23, 2016
Mitralign Inc. announced it has raised $39.8 million to date in a Series E equity round of financing.
TAVR outcomes, aortic valve gradient, JACC study
News | Heart Valve Technology| May 23, 2016
Patients with a combination of left ventricular dysfunction and low aortic valve gradient have higher mortality rates...
Direct Flow Medical, TAVR device, DISCOVER trial, three-year results, EuroPCR 2016
News | Heart Valve Technology| May 20, 2016
Direct Flow Medical Inc. presented three-year results from its prospective, multicenter DISCOVER Trial at the EuroPCR...
RDAVR, aortic valve replacement, Edwards Intuity, TRANSFORM Trial, AATS meeting
News | Heart Valve Technology| May 18, 2016
The TRANSFORM trial was designed to evaluate the safety and performance of an investigational rapid deployment aortic...
NeoChord, DS1000 System, FDA approval, U.S. pivotal trial
News | Heart Valve Technology| May 17, 2016
NeoChord Inc. announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug...
4Tech Inc., TriCinch transcatheter tricuspid valve repair device, Jean-Claude Laborde

Image courtesy of 4Tech Inc.

News | Heart Valve Technology| May 16, 2016
4Tech Inc. announced its partnership with Jean-Claude Laborde, M.D., as a research and development (R&D) and...

A Medtronic CoreValve TAVR device being deployed under angiographic image guidance.

 

Feature | Heart Valve Technology| May 16, 2016
 
aortic valve reconstruction, surgery, PinnacleHealth, Pennsylvania
News | Cardiovascular Surgery| May 04, 2016
Three PinnacleHealth patients recently underwent a new procedure for aortic valve reconstruction using the patients'...
Feature | Business| April 28, 2016 | Dave Fornell
 
Overlay Init