The FDA granted Cardiac Dimensions an investigation device exemption for the company to begin a pivotal trial evaluating the Carillon mitral contour system to treat symptomatic functional mitral regurgitation associated with heart failure.
The FDA has not approved the Carillon mitral contour system, but has received a CE Mark and has been implanted in approximately 700 patients in Europe, Australia, New Zealand and the Middle East.
The trial is expected to enroll 400 patients at up to 50 centers in North America, Europe and Australia. The researchers will randomize patients to receive the Carillon mitral contour system or guideline directed medical management.
Cardiac Dimensions said in a news release that an estimated two million people in the U.S. have symptomatic functional mitral regurgitation associated with heart failure.
In March 2015, Cardiac Dimensions announced it had raised $43 million support the REDUCE FMR trial, which is still enrolling patients. That study is designed to enroll 120 patients at approximately 25 centers in Europe, Australia and New Zealand, according to the company.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.