Cardiac Dimensions said today that the FDA granted an investigational device exemption for a pivotal trial of its Carillon mitral valve repair device.
Kirkland, Wash.-based Cardiac Dimensions said the 400-patient study will compare the device with guideline-directed treatment of symptomatic functional mitral regurgitation associated with heart failure after a year.
The percutaneous Carillon annuloplasty device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to reshape the mitral annulus by bending the coronary sinus. The device met its endpoints in a trio of previous studies in Europe, Cardiac Dimensions said; the 120-patient Reduce FMR trial is still enrolling patients in Europe, Australia and New Zealand, the company said.
“The approval of the IDE for the Carillon system is a significant milestone for our company,” president & CEO Gregory Casciaro said in prepared remarks. “We have seen substantial interest and adoption of the Carillon system in Europe and are excited to take the 1st step to bring this innovative treatment to patients and physicians in the U.S.”
“This Carillon trial is an important next step to potentially advance the treatment of patients with functional mitral regurgitation,” added clinical steering committee chairman Dr. Martin Leon of the Columbia University Medical Center. “There is a significant need for a new minimally invasive solution for this extremely ill and underserved patient population, as current mainstream therapies are limited.”
“The Carillon device is unlike any other mitral regurgitation therapy. It offers patients annular reduction and keeps adjunctive therapy options open,” said co-principal investigator Dr. Samir Kapadia of the Cleveland Clinic. “I am excited to participate in this important pivotal trial and look forward to the results.”