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

Hitachi and West Virginia University Partner to Advance Left Ventricular Mechanical Function Evaluation
News | Cardiovascular Ultrasound| July 21, 2017
Hitachi Healthcare and the West Virginia University Heart and Vascular Institute announced the formation of a new...
Edwards Sapien 3 TAVR valve will be implanted in asymptomatic aortic stenosis patients in the EARLY TAVR Trial
Feature | Heart Valve Technology| July 14, 2017
July 14, 2017 — Morristown Medical Center, part of Atlantic Health System, has randomized the first patient in the wo
Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve

An example of Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve.

Technology | Computed Tomography (CT)| July 12, 2017
July 12, 2017 — At the 2017 annual meeting for the Society of Cardiovascular Computed Tomography (SCCT), Ziosoft show
Medtronic's CoreValve Evolut R gained FDA approval for intermediate risk patients

An illustration of the self-expanding CoreValve Evolut R TAVR valve half deployed in the aortic root.

Feature | Heart Valve Technology| July 10, 2017
The U.S. Food and Drug Administration (FDA) has cleared an additional indication to expand the use Medtronic's self-...
HAART 300 Aortic Annuloplasty Device Sees U.S. Pilot Launch, First Commercial Use
News | Annuloplasty Rings| July 05, 2017
July 5, 2017 — BioStable Science & Engineering Inc.
Novel Approach May Improve Valve Function in Some Patients

Image courtesy of Messas, et al. JACC Basic to Translational Medicine.

News | Heart Valve Technology| June 30, 2017
June 30, 2017 — Pulsed cavitation ultrasound can be used to remotely soften human degenerative calcified biosprosthet
Mitralign Announces First European Subject Enrolled in SCOUT II Study of Trialign System
News | Heart Valve Technology| June 27, 2017
Mitralign Inc. announced the commencement of its SCOUT II study in Europe, with the Trialign System for the treatment...
BioTrace Medical's Tempo Lead Shows Stability and Safety in Real-World Performance
News | Leads Implantable Devices| June 20, 2017
BioTrace Medical Inc. announced that the company’s Tempo Temporary Pacing Lead was featured in an oral presentation and...
heart valve regurgitation seen on an echocardiogram, cardiac ultrasound, from ASE study
News | Cardiovascular Ultrasound| June 16, 2017
June 15, 2017 – While much attention has been focused on ways to lower heart disease-related injuries and deaths, the
Mitral Valve regurgitation showed on an echocardiogram, cardiac ultrasound

Mitral valve regurgitation showed on an echocardiogram. Image from Toshiba.

News | Heart Valve Technology| June 15, 2017
June 15, 2017 — 4C Medical Technologies Inc., a developer of minimally invasive therapies for structural heart diseas
Overlay Init