Abbott has presented clinical study data from a Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II ) High Surgical Risk cohort of its MitraClip System for the treatment of mitral regurgitation (MR).
The CE-marked catheter-based device is delivered via the femoral vein to reduce MR by clipping together the leaflets of the mitral valve to allow the heart to more efficiently pump blood.
The trial has included data from multi-center EVEREST II High Risk and REALISM continued access studies to evaluate the device.
The study, which has included 351 symptomatic US patients with 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 percent 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.
Abbott Vascular chief medical officer and medical affairs divisional vice president 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."
