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

 Retired National Football League (NFL) star Ed White, the former Chargers guard and four-time Pro Bowler, waited until the FDA approved TAVR for low-risk patients like himself to avoid open-heart surgery.

Retired National Football League (NFL) star Ed White, the former Chargers guard and four-time Pro Bowler, waited until the FDA approved TAVR for low-risk patients like himself to avoid open-heart surgery.

Feature | Heart Valve Technology | October 29, 2019
October 29, 2019 — When Scripps cardiologists discovered early in 2019 that retired National Football League (NFL) gr
A Sapien 3 TAVR valve in position as seen under GE Assist guidance on angiography. Study Finds Sustained Benefit for TAVR vs. SAVR at One Year. #TCT2019 #TCT19

A Sapien 3 TAVR valve in position as seen under GE Assist guidance on angiography.

News | Heart Valve Technology | October 04, 2019
October 4, 2019 – A new analysis of the PARTNER 3 Trial data found a modest, but significant, improvement in one-year
Five-year results from the PARTNER 2A Trial found patients with severe aortic stenosis (AS) and intermediate surgical risk who underwent Sapien 3 transcatheter aortic valve replacement (TAVR) had similar rates of death and disabling stroke compared to those who had surgical aortic valve replacement (SAVR). However, TAVR using a transthoracic approach had poorer outcomes compared to SAVR. #TCT2019
News | Heart Valve Technology | October 03, 2019
October 3, 2019 – Five-year results from the PARTNER 2A Trial found patients with severe aortic stenosis (AS) and int
The Boston Scientiofic Acurate Neo TAVR valve did not meet non-inferiority to the Sapien 3 valve in patients with severe aortic stenosis. #TAVR #TCT2019
News | Heart Valve Technology | October 02, 2019
October 2, 2019 – The first randomized trial to compare the safety and efficacy of the new Boston Scientific Acurate
The Portico FDA investigational device exemption (IDE) study found that 30-day safety and one-year effectiveness outcomes of a novel self-expanding transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis (AS) at high or extreme-risk for surgery was noninferior to contemporary FDA-approved TAVR systems. #TAVR #TCT2019
News | Heart Valve Technology | October 02, 2019
October 2, 2019 – The Abbott Portico FDA investigational device exemption (IDE) study found that 30-day safety and on
Medtronic Launches Evolut Pro+ TAVR System
Technology | Heart Valve Technology | September 24, 2019
Medtronic announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Evolut Pro+ transcatheter...
Reducing Secondary Mitral Regurgitation in Heart Failure Does Not Improve Two-year Outcomes
News | Heart Valve Technology | September 11, 2019
Percutaneous reduction of secondary mitral regurgitation in patients with heart failure does not lower death and...
Abbott Launches Pivotal Trial of TriClip Tricuspid Valve Repair System
News | Heart Valve Technology | September 05, 2019
Abbott announced the launch of the company's TRILUMINATE Pivotal trial evaluating the safety and effectiveness of its...
Overlay Init