Cardiac Dimensions has completed its European AMADEUS study, a 30-patient safety and performance study of the Carrillon Mitral Contour System conducted at six centers in Germany, Poland and the Netherlands.
The AMADEUS (CArillon Mitral Annuloplasty Device European Union Study) study met its primary safety endpoint and its secondary performance endpoints at six months, according to the Kirkland, Wash.-based company.
The Carillon system is a percutaneous treatment of functional mitral regurgitation, currently under investigational use in Europe, South America and Australia only, Cardiac Dimensions said.
The complete results will be presented at the European Society of Cardiology (ESC) later this year by principal investigator Joachim Schofer, MD, from the Hamburg University Cardiovascular Center in Hamburg, Germany.
“We could not be happier with the data, and we now turn our attention to enrollment in our new TITAN study,” said Rick Stewart, president and CEO of Cardiac Dimensions.