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

4Tech, TriCinch TTVR, transcather tricuspid valve repair device, first implant
News | Heart Valve Technology| September 22, 2016
4Tech Inc. announced that its TriCinch device has been used in the world’s first-ever successful transcatheter...
Transesophageal Echo, TEE. Interventional echocardiography, interventional echo, Philips, CX50

Transesophageal echo (TEE) has become an essential part of the new transcatheter structrual heart therapies, giving rise to a new sub-speciality of interventional echocardiography.  

Feature | Cath Lab Navigation Aids| September 21, 2016 | Dave Fornell
The rapid growth of transcatheter structural heart procedures and the need for increased use of echocardiography as a
Claret Medical, Sentinal CPS, cerebral protection system, FDA marketing application, TAVR, embolic protection
News | Embolic Protection Devices| September 20, 2016
Claret Medical announced its filing of a marketing application with the U.S. Food and Drug Administration (FDA) for...
Edwards sapien, intermediate risk patients, CE mark
News | Heart Valve Technology| September 20, 2016
September 19, 2016 — Edwards Lifesciences received European CE mark to expand use of the Edwards Sapien 3 transcathet
Lotus Edge Valve, CE mark, boston scientific, TAVR, TAVI

The Lotus Edge system in its deployed position. The Lotus valve expands outward as it is compressed and buckled in the deployment position. It also has a skirt to help eliminate paravalvular leaks.

News | Heart Valve Technology| September 19, 2016
September 19, 2016 — Boston Scientific received European CE mark approval for its Lotus Edge Valve System, the compan
Valtech Cardio, Cardioband Tricuspid, Cardioband Mitral, PCR London Valves 2016, study data
News | Heart Valve Technology| September 19, 2016
Valtech Cardio Ltd. announced that it will present the first-in-man data for its Cardioband Tricuspid (TR) system at...
bundled payments for cardiology, CMS cardiac reimbursements
Feature | Business| September 13, 2016 | John W. Meyer, MPH, FACHE
The movement away from traditional Medicare fee-for-service reimbursement and into bundled payment models by the Depa
Xeltis bioabsorbable aortic conduit, endogenous tissue restoration, ETR, preclinical data, ISACB 2016
News | Heart Valve Technology| September 09, 2016
Six-month preclinical data from trials of a Xeltis bioabsorbable aortic conduit were presented at the 2016 scientific...
Pradaxa, dabigatran, GLORIA-AF registry, ESC Congress 2016, NVAF
News | Antiplatelet and Anticoagulation Therapies| September 01, 2016
First outcome results from the GLORIA-AF Registry show that treatment with Pradaxa (dabigatran etexilate mesylate) was...
Edwards Intuity aortic valve, surgical aortic valve replacement, PinnacleHealth, first U.S. implants
News | Heart Valve Technology| August 26, 2016
This week, PinnacleHealth, Harrisburg, Pa., became the first hospital in the country to implant the Edwards Intuity...
Overlay Init