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

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'...
AtriCure, AtriClip PRO2 LAA Exclusion System, left atrial appendage, FDA clearance
Technology | Left Atrial Appendage (LAA) Occluders| April 29, 2016
April 29, 2016 — AtriCure Inc. announced U.S.
Feature | Business| April 28, 2016 | Dave Fornell
 
Mitralign Percutaneous Annuloplasty System, MPAS, CE Mark approval
News | Annuloplasty Rings| April 27, 2016
Mitralign Inc. announced its Mitralign Percutaneous Annuloplasty System (MPAS) has received CE mark approval from its...
TAVR, Sapien 3, ACC.16
Feature | Heart Valve Repair| April 19, 2016 | Michael J. Rinaldi, M.D., FACC, FSCAI
The continuation of positive clinical trial data for transcatheter aortic valve repair (TAVR), showing it is equal to
Sapien III, Sapien 3, PARTNER II

The Sapien 3 valve has a skirt that has helped significantly reduce paravalvular leaks, which were an issue with earlier generation Sapien devices. 

Feature | Heart Valve Repair| April 15, 2016
April 15, 2016 — Intermediate-risk patients who received transcatheter aortic valve replacement (TAVR) with the lates
TAVR runoff image

A 3-D CT reconstruction of a TAVR run-off image to assess the femoral access route using Toshiba's Aquillion One and Vital Images advanced visualization technologies. 

Feature | Heart Valve Repair| April 15, 2016
April 15, 2016 — Accurate and precise anatomical information is crucial to successful transcatheter aortic valve repl
TAVR, Sapien 3, ACC.16

Implantation of an Edwards Lifesciences Sapien valve under angiography during the balloon inflation to expand the valve into the aortic annulus. 

Feature | Heart Valve Repair| April 15, 2016
April 15, 2016 —The more frequently a hospital performs a transcatheter aortic valve replacement (TAVR) the better pa
Sponsored Content | Videos | Left Atrial Appendage (LAA) Occluders| April 15, 2016
David Holmes, M.D., professor of medicine, Mayo Clinic College of Medicine and consultant, Department of Internal Med
Sponsored Content | Videos | Heart Valve Repair| April 15, 2016
Chandan Devireddy, M.D., assistant professor of medicine at Emory Healthcare in Atlanta and an investigator in the PA
Overlay Init