Abbott has presented new data from the landmark Endovascular Valve Edge-to-Edge REpair Study (EVEREST II) trial, which demonstrated the durability, safety and clinical benefit of the company's investigational MitraClip system for the two causes of mitral regurgitation (MR) functional MR (FMR) or degenerative MR (DMR).
In the 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 (42.6%).
Abbott said that the MitraClip system also demonstrated consistent results in both FMR and DMR patients with both subgroups showing significant improvement at one year from baseline measures of heart function, symptoms and quality of life.
Additionally, Abbott has presented results on a subset of patients within the EVEREST II trial who had progressed to two years post procedure, which showed that the positive clinical results achieved at one year with the MitraClipsystem are sustained at two years in patients with significant MR.
The preliminary two-year results evaluated 86 of the 217 patients who had successful MR reduction after treatment with a MitraClip device or open heart surgery, and showed there was no difference in the need for subsequent mitral valve surgery through two years between these two groups.
The MitraClip system includes a catheter-based device, which is delivered to the heart through a blood vessel in the leg (femoral vein). The MitraClip device is designed to reduce MR by clipping together the leaflets of the mitral valve (one of the four valves of the heart).
Reportedly, the MitraClip system had received CE mark in March 2008. In the US, the MitraClip device is limited by federal law to investigational use only and is not available for sale. The MitraClip system is currently under review for approval by the FDA.
Charles Simonton, divisional vice president of medical affairs and chief medical officer at Abbott Vascular, said: “Continued advancements in medical device technology are bringing more options and tremendous benefits to patient care. The MitraClip device is a novel treatment, and these preliminary data indicate the device has sustained mid-term benefits and can be an option for some patients with FMR or DMR.”