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
Technology | April 22, 2011
FDA Clears Trifecta Stented Tissue Aortic Valve
News | Clinical Decision Support| October 16, 2017
The American College of Cardiology (ACC), along with several partnering societies, recently released appropriate use...
News | Heart Valve Technology| October 11, 2017
An analysis of more than 1,000 minimally invasive aortic valve replacements and more than 400 additional associated...
News | Heart Valve Technology| October 02, 2017
Medtronic plc recently announced a new post-market clinical study to evaluate its CoreValve Evolut Pro valve in...
News | Robotic Systems| September 22, 2017
The Montreal Heart Institute (MHI) announced the acquisition of the da Vinci Xi, a new-generation surgical robot, and...
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
News | Cardiovascular Surgery| September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Feature | September 11, 2017
September 11, 2017 — From numerous high-quality submissions, Transcatheter Cardiovascular Therapeutics (TCT) has sele
News | Cardiovascular Surgery| September 08, 2017
September 8, 2017 — ClearFlow Inc.
Feature | Left Atrial Appendage (LAA) Occluders| September 07, 2017
September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to