Global healthcare company Abbott has reported study data from a clinical trial of its catheter-based MitraClip System for the treatment of mitral regurgitation (MR).
Delivered via the femoral vein, the CE-marked device reduces MR by clipping together the leaflets of the mitral valve to allow the heart to more efficiently pump blood.
The trial, endovascular valve edge-to-edge repair study (EVEREST II) high surgical risk cohort, has included data from patients enrolled in the multi-centre EVEREST II high risk and REALISM continued access studies, to evaluate the device.
The study, which has included 351 symptomatic US patients that are too high risk for open mitralvalve surgery, demonstrated a 30-day mortality rate significantly lower than expected for surgery (4.8% for patients treated with the MitraClip system versus 18.2% predicted surgical mortality, p<0.0001).
The study also showed a low rate of adverse events, an implant success rate of 96% and acute reduction in MR to 2+ or less achieved in 86% of patients.
Clinically significant improvement in left ventricular size, significant improvements in NYHA Functional Class and SF-36 Quality of Life scores, and significantly reduced rates of hospitalisation for heart failure (48% reduction from one year post-discharge compared to the year prior to treatment, p<0.0001) were also reported, according to the company.
University of Virginia Health System cardiovascular medicine professor Dr Scott Limassociate said; "The findings of the EVEREST II high surgical risk cohort suggest that treatment with the MitraClip device represents a new option that could allow these high-risk patients to return to activities they enjoy, and results in a reduction in hospitalisations for heart failure."
Abbott Vascular chief medical officer and medical affairs divisional vice president Dr Charles Simonton said; "We look forward to the March 20 FDA Advisory Committee meeting to discuss the MitraClip system as a treatment option for this patient group in the United States."