Cardiac Dimensions today touted the publication of a small study of its Carillon mitral valve repair system in the Journal of Invasive Cardiology, saying the device led to significant improvement in patients with functional mitral regurgitation.
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 single-center study of 17 patients with moderate to severe secondary mitral regurgitation showed that mitral regurgitation was lowered from 2.8 (±2.4) to 1.9 (±0.8) in the acute setting; after 30 days the rate was 1.5 (±0.75).
“Indirect mitral annuloplasty is feasible outside of controlled trials, and is associated with successful improvement of mitral regurgitation. Although coronary compromise needs to be addressed as part of the implantation procedure, this issue limits implantation of the device in only a small percentage of cases,” the study’s authors wrote.
“In this ‘real-life’ setting, we observed a marked reduction in FMR and continued improvement in the condition over time, with the majority of patients experiencing clinical success similar to the results of the Titan trial,” lead author Dr. Norbert Klein of the University Hospital Leipzig said in prepared remarks. “In addition, we experienced short procedure times, ease of implantation and compatibility with other cardiac therapies.”