Feature | March 19, 2013

Lower-Profile Sapien XT Transcatheter Heart Valve Associated With Improved Procedural Outcomes

Preliminary results from inoperable cohort of the PARTNER II Trial presented at ACC 2013

Edward Structural Heart Valve Repair Clinical Trial Sapien XT Transcatheter

March 18, 2013 — Edwards Lifesciences Corporation announced that preliminary results from The PARTNER II clinical trial demonstrated similar one-year outcomes in mortality and major clinical events between the Edwards Sapien XT transcatheter aortic valve and the Edwards SAPIEN valve, yet fewer vascular events with the lower-profile Sapien XT valve. These data from The PARTNER II Trial studying transcatheter aortic valve replacement (TAVR) in inoperable patients with severe, symptomatic aortic stenosis were presented as a late-breaking clinical trial at the American College of Cardiology's (ACC) 62nd Annual Scientific Session in San Francisco.

The PARTNER II Trial enrolled 560 patients deemed inoperable for traditional open-heart surgery at 28 hospitals in the United States between April 2011 and February 2012. Patients were randomized to receive one of the two Edwards transcatheter aortic heart valves: 276 received the Sapien valve, and 284 received the Sapien XT valve.

The U.S. Food and Drug Administration (FDA) approved the Sapien valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012. The Sapien XT valve is an investigational device not yet available commercially in the United States.

Edwards anticipates submitting data from the inoperable cohort (Cohort B) of The PARTNER II Trial to the FDA in the second quarter. The company expects to complete enrollment in the intermediate risk cohort (Cohort A) of The PARTNER II Trial mid-year.

For more information: www.edwards.com

Related Content

Edwards Lifesciences Centera self expanding transcatheter (TAVR) valve
News | Heart Valve Technology| May 24, 2017
May 24, 2017 — Late-breaking data presented at EuroPCR 2017 demonstrating excellent clinical outcomes for...
Nearly One-Quarter of Patients Say Mechanical Heart Valve Disturbs Sleep
News | Heart Valve Technology| May 19, 2017
Nearly one-quarter of patients with a mechanical heart valve say it disturbs their sleep, according to research...
Analysis Looks at Role Type of Valve Plays in Patient Outcomes Post-TAVR
News | Heart Valve Technology| May 15, 2017
For patients who undergo transcatheter aortic valve replacement (TAVR), their risk factors, not the type of valve used...
Baylor Jack and Jane Hamilton Heart and Vascular Hospital Implants CoreValve Evolut Pro Valve
News | Heart Valve Technology| May 03, 2017
The Baylor Jack and Jane Hamilton Heart and Vascular Hospital (BHVH) transcatheter aortic valve replacement (TAVR) team...
AtriCure's AtriClip System Surpasses 100,000 Units Sold Worldwide
News | Left Atrial Appendage (LAA) Occluders| April 25, 2017
AtriCure Inc. announced it has sold more than 100,000 AtriClip Left Atrial Appendage Exclusion System devices worldwide...
Alabama Medical Center First in Southeast to Offer CoreValve Evolut Pro TAVR Device
News | Heart Valve Technology| April 20, 2017
The Structural Heart Program at Princeton Baptist Medical Center, (Birmingham, Ala.) recently became the first center...
Updated AATS Guidelines Help Cardiovascular Surgeons Navigate Challenges of Managing Ischemic Mitral Regurgitation
News | Heart Valve Technology| April 20, 2017
April 20, 2017 — Mitral regurgitation can occur in up to 50 percent of patients with ischemic heart disease and even
PinnacleHealth Initiates Clinical Study of TriGuard Embolic Protection Device
News | Embolic Protection Devices| April 11, 2017
Through a new clinical trial, patients at Harrisburg, Pa.-based PinnacleHealth have access to an investigational device...
Boston Scientific is buying TAVI valve maker Symetis, which has European approval for its Acurate Neo valve

The Symetis Acurate Neo TAVI valve.

News | Heart Valve Technology| April 11, 2017
April 10, 2017 — Boston Scientific recently announced a $435 million cash deal to acquire Symetis SA, a privately-hel
Overlay Init