News | July 24, 2007

St. Jude Implants First Stented Tissue Heart Valve in Clinical Trial

July 25, 2007 - St. Jude Medical, Inc. announced the first patient implant in its clinical trial of Trifecta, a new investigational stented, pericardial tissue heart valve, that will undergo a trial test its safety and efficacy as a replacement for the aortic valve.

The clinical trial is a multi-center, prospective study enrolling patients at approximately 22 medical centers in the U.S. and Canada. The study will determine efficacy by the valve's hemodynamic performance and will include approximately 500 adult patients. The first implant was performed by Hartzell V. Schaff, M.D., chair, Cardiovascular Surgery Division, Mayo Clinic, Rochester, Minn., and the trial's principal investigator.

"The promise of the Trifecta tissue valve to potentially deliver superior hemodynamic performance to currently available stented or stentless aortic valves is very exciting," said Tirone E. David, M.D., Head of the Division of Cardiovascular Surgery, Toronto General Hospital, Toronto, who is an investigator in the trial.

For more information: www.sjm.com

Related Content

Mick Jagger Recovering After TAVR Procedure
News | Heart Valve Technology | April 08, 2019 | Jeff Zagoudis, Associate Editor
Rolling Stones frontman Mick Jagger is reportedly recovering after undergoing a transcatheter aortic valve valve...
 Evolut Low Risk Trial compared the minimally invasive Evolut transcatheter aortic valve replacement (TAVR) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients. The randomized trial, which met its primary non-inferiority endpoint of all-cause mortality or disabling stroke at two years compared to surgery (5.3 vs. 6.7 percent; posterior probability of non-inferiority >0.999), was presented at the American College of Cardiology (ACC) 2019 meeting
News | Heart Valve Technology | April 03, 2019
April 3, 2019 – The ACC.19 late-breaking landmark Evolut Low Risk Trial compared the minimally invasive Evolut transc
TAVR Outperforms Surgery in Younger, Low-Risk Aortic Stenosis Patients
News | Heart Valve Technology | March 22, 2019
Among patients with severe symptomatic aortic stenosis at low surgical risk, transcatheter aortic valve replacement (...
ACC Launches Transcatheter Valve Certification
News | Heart Valve Technology | March 14, 2019
March 14, 2019 — Beginning in mid-2019, hospitals performing...
FDA Approves MitraClip for Use in Heart Failure Patients With Functional Mitral Regurgitation
Feature | Heart Valve Technology | March 14, 2019 | Jeff Zagoudis, Associate Editor
March 14, 2019 — The U.S.
Scientists Discover New Type of Immune Cells Essential for Forming Heart Valves

Microscopic images of a normal heart valve in a mouse, left, and a heart valve grown in a lab with heart-derived macrophages blocked, right. Without those macrophages, the valves are thick and deformed. Image courtesy of Developmental Cell/UCLA Broad Stem Cell Research Center.

News | Heart Valve Technology | March 06, 2019
UCLA researchers have identified for the first time the origin of an immune cell that plays a critical role in the...
Global Market for Transcatheter Treatments to Double in Next Five Years
News | Heart Valve Technology | March 01, 2019
When it comes to treatment options for a damaged heart valve, nothing is getting more attention than transcatheter...
Overlay Init