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

coherex Wave Crest LAA Occluder

Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.

News | November 24, 2015
November 24, 2015 — Biosense Webster announced it has acquired Coherex Medical Inc., a privately held medical device
News | Heart Valve Repair| November 23, 2015
NaviGate Cardiac Structures Inc. (NCSI) announced that a first-in-human implant of its catheter-guided, mitral-valved...
Boston Scientific, Watchman FLX, LAA closure device, CE mark, first European implants

Image courtesy of Boston Scientific

News | Left Atrial Appendage (LAA) Occluders| November 20, 2015
Boston Scientific announced the first implants of the Watchman FLX left atrial appendage closure (LAAC) device
Neovasc, Tiara, transcatheter mitral valve, TMVR

The Neovasc Tiara transcatheter mitral valve is currently being tested in U.S. and international clinical trials. 

Feature | Heart Valve Repair| November 12, 2015 | Dave Fornell
The advent of transcatheter valve repair and replacement technologies is one of those rare instances where there is a
SALUS trial, Direct Flow Medical TAVR device, Medtronic CoreValve, PinnacleHealth CardioVascular Institute

Image courtesy of Direct Flow Medical

News | Heart Valve Repair| November 10, 2015
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a randomized trial studying a new...
Sponsored Content | Videos | TCT| November 05, 2015
Tom Watson, clinical analyst for MDBuyLine, and DAIC Dave Fornell discuss some of the technology trends at the 2015 T
aortic valve replacment, AVR, severe aortic stenosis, CURRENT AS registry, TCT 2015
News | Heart Valve Repair| October 27, 2015
A large observational registry found that initial aortic valve replacement (AVR) in asymptomatic patients with severe...
Medtronic CoreValve, real-world clinical outcomes, STS/ACC TVT Registry, TCT 2015

Image courtesy of Medtronic

News | Heart Valve Repair| October 22, 2015
Medtronic plc released the first CoreValve transcatheter aortic valve replacement (TAVR) system outcomes data using...
Direct Flow Medical TAVR System, DISCOVER post-market study, real-world results, TCT 2015

Image courtesy of Direct Flow Medical Inc.

News | Heart Valve Repair| October 22, 2015
Direct Flow Medical Inc. announced one-year outcomes from the DISCOVER post-market study that demonstrate excellent...
BRAVO 3 trial results, bivalirudin, heparin, anticoagulation, TAVR, TCT 2015
Feature | Antiplatelet and Anticoagulation Therapies| October 20, 2015
Results from the BRAVO 3 trial found that bivalirudin did not significantly reduce major bleeding rates at 48 hours or...
Overlay Init