Cardiac Dimensions has implanted its first Carillon mitral contour system as part of its new TITAN study.
Six centers across Europe will host the study, enrolling up to 50 patients. The TITAN study will assess safety and efficacy at 1, 6, 12, 18, and 24 months, then annually at three, four and five years, according to the Redmond, Wash.-based company.
The Carillon system is a percutaneous treatment of functional mitral regurgitation (MR), currently under investigational use in Europe, South America and Australia only.
"The first patient, a 57 year-old male, presented with MR grade 3 and NYHA class III. The procedure went very smoothly and we were quite satisfied with the result,” said Michael Haude, MD, chief of cardiology at the Stadtische Kliniken Neuss in Neuss, Germany. “The patient had been in the hospital for several weeks prior to the procedure and is now doing very well.”
Approximately five million people in the U.S. and more than 20 million people worldwide suffer from heart failure.