Technology | April 22, 2011

FDA Clears Trifecta Stented Tissue Aortic Valve

April 22, 2011 – The U.S. Food and Drug Administration (FDA) has cleared the Trifecta valve, by St. Jude Medical. The valve, a clinically-proven replacement for diseased, damaged or malfunctioning aortic heart valves, mimics the flow of a natural, healthy heart. The valve was designed for excellent hemodynamic performance (the optimization of blood flow through the valve) and long-term durability. To ensure the structural integrity of the valve, it is constructed using a polyester and tissue-covered titanium stent, or base. The valve features leaflets manufactured from pericardial tissue attached to the exterior of the valve stent. This design allows the leaflets to open more fully and efficiently, mimicking the performance of a healthy aortic heart valve and limiting tissue abrasion through tissue-to-tissue (stent-to-leaflet) contact. Also contributing to the valve’s durability, it offers the Linx AC Technology, an anticalcification treatment designed to reduce tissue mineralization (hardening), one of the primary causes of valve deterioration. It also offers several features that improve the ease of implantation, including the valve’s unique holder, designed to improve visibility and cuff access for suturing, and customized sizes. “Physicians around the world have already voiced tremendous excitement and satisfaction with the Trifecta valve,” said Frank J. Callaghan, president of the St. Jude Medical cardiovascular division. “Trifecta has demonstrated outstanding hemodynamic performance and has improved the lives of patients with aortic valve disease.” The valve was approved by regulatory authorities in Europe and Canada in 2010. For more information: www.sjm.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'...
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...
CABG, bypass surgery, heart failure, NHLBI study
News | Cardiovascular Surgery| April 25, 2016
Scientists have found that a greater number of patients with coronary artery disease may benefit from coronary artery...
post-operative atrial fibrillation, AFib, heart rate, rhythm control, ACC.16
News | Atrial Fibrillation| April 20, 2016
In the first large randomized trial to directly compare two approaches to preventing atrial fibrillation following...
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 | Heart Valve Repair| April 15, 2016
John Carroll, M.D., professor of medicine at the University of Colorado School of Medicine, and director of intervent
Overlay Init