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