Abbott’s new MitraClip system is safe and provides clinical benefits for the two causes of mitral regurgitation (MR), a new study has found.
The MitraClip system contains a catheter-based device delivered to the heart through a blood vessel in the leg (femoral vein), to reduce significant MR by clipping together the leaflets of the mitral valve.
The system demonstrated significant improvement after one year from baseline measures of heart function, symptoms and quality of life in both functional MR (FMR) and degenerative MR (DMR) patients, the study reported.
According to the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II) trial, the 30-day major adverse event rate in the MitraClip arm was similar for the FMR and DMR patient subgroups (8.2% for FMR patients, 8.1% for DMR patients), both lower than the surgical control group (42%).
The study also evaluated 86 of the 217 patients who had successful MR reduction after treatment with a MitraClip device or open heart surgery and showed that there was no difference in the need for subsequent mitral valve surgery within two years between these two groups.
The MitraClip system has received CE Mark and is currently under review for approval by the US Food and Drug Administration.