Technology | Heart Valve Technology | January 02, 2019

Edwards' Sapien 3 Ultra Transcatheter Heart Valve Receives FDA Approval

Updated device features valve enhancements and new delivery system

Edwards' Sapien 3 Ultra Transcatheter Heart Valve Receives FDA Approval

January 2, 2019 — Edwards Lifesciences Corp. announced that the Sapien 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement (TAVR) in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery.

The Sapien 3 Ultra features enhancements on the valve over previous versions and a new “on-balloon” delivery system to address the needs of both patients and clinicians. It reportedly features an extended skirt to help avoid paravalvular leaks and a 14-French low profile sheath.

"The Edwards Sapien 3 Ultra system provides meaningful technology improvements that help further optimize the transcatheter aortic valve replacement procedure, adding simplicity and advancing patient care," said John Webb, M.D., director of interventional cardiology and cardiac catheterization laboratories at St. Paul's Hospital, Vancouver, and professor of cardiology at the University of British Columbia.

For more information: www.edwards.com

Related Content

Illustration showing the catheter steps for the LAMPOON procedure designed to prevent left ventricular outflow tract (LVOT) obstruction . From Dr. Jaffar M. Khan and the Laboratory of Cardiovascular Intervention, led by Dr. Robert J. Lederman.

Figure 1: Illustration showing the catheter steps for the LAMPOON procedure. From Dr. Jaffar M. Khan and the Laboratory of Cardiovascular Intervention, led by Dr. Robert J. Lederman.

Feature | Heart Valve Technology | May 22, 2019
Researchers at the National, Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH
Edwards Announces Research Milestones for Pascal Transcatheter Mitral Valve Program
News | Heart Valve Technology | May 22, 2019
Edwards Lifesciences Corp. announced strategic clinical and regulatory milestones for its Edwards Pascal transcatheter...
Videos | Heart Valve Technology | May 20, 2019
A demonstration of how to calculate the neo-left ventricular outflow tract (neo-LVOT) on CT imaging for a transcathet
Study Finds TAVR Can Be Considered for Patients in All Surgical Risk Classes
News | Heart Valve Technology | May 08, 2019
Transcatheter aortic valve replacement (TAVR) has been studied as an alternative to surgical aortic valve replacement...
Boston Scientific Receives FDA Approval for Lotus Edge Aortic Valve System
Feature | Heart Valve Technology | April 23, 2019 | Dave Fornell, Editor
Boston Scientific Corp. announced it has received U.S. Food and Drug Administration (FDA) approval for the Lotus Edge...
New Consensus Document Explores Optimized Care for Valvular Heart Disease Patients
News | Heart Valve Technology | April 22, 2019
April 22, 2019 — Five cardiovascular professional societies released a new consensus document on optimizing care for
Mick Jagger Recovering After TAVR Procedure
News | Heart Valve Technology | April 08, 2019 | Jeff Zagoudis, Associate Editor
Rolling Stones frontman Mick Jagger is reportedly recovering after undergoing a transcatheter aortic valve valve...
 Evolut Low Risk Trial compared the minimally invasive Evolut transcatheter aortic valve replacement (TAVR) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients. The randomized trial, which met its primary non-inferiority endpoint of all-cause mortality or disabling stroke at two years compared to surgery (5.3 vs. 6.7 percent; posterior probability of non-inferiority >0.999), was presented at the American College of Cardiology (ACC) 2019 meeting
News | Heart Valve Technology | April 03, 2019
April 3, 2019 – The ACC.19 late-breaking landmark Evolut Low Risk Trial compared the minimally invasive Evolut transc
Overlay Init