Abbott has presented data from a landmark Everest II (Endovascular Valve Edge-to-Edge REpair STudy) trial at the American College of Cardiology's 59th annual scientific session. The trial has demonstrated that its investigational MitraClip system met both its primary safety and effectiveness endpoints, suggesting that the minimally invasive MitraClip procedure may be a treatment option for patients with mitral regurgitation (MR).
In the study, the MitraClip device at one year, has demonstrated meaningful clinical benefits for patients with MR, including improvements in heart function, quality of life, and normal physical activity, and a decrease in cardiac symptoms. The Everest II trial is the randomized trial of any minimally invasive mitral valve repair device compared to mitral valve surgery.
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).
In the Everest II trials, primary safety endpoint of major adverse events (MAEs) at 30 days, the MitraClip system has demonstrated a superior safety profile compared to surgical repair or replacement. Major adverse events is defined as a composite of 12 pre-specified adverse events. In the primary effectiveness endpoint, the MitraClip device was non-inferior to surgery at one year.
With 95% confidence, the clinical success rate of the MitraClip device falls within 25.4% of the clinical success rate of the surgical control. The MitraClip system has received CE Mark in March 2008. The MitraClip device is an investigational device in the US, and is currently under review for approval by the FDA.
Ted Feldman, FSCAI, director, Cardiac Catheterization Laboratory and The Mr and Mrs Charles Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem, Evanston, IL, and co-principal investigator of the Everest II trial, said: “In the Everest II trial, the catheter-based system exhibited a favorable safety profile, while providing meaningful and sustained clinical benefits.
“The positive trial results validate my experience that the procedure is a valuable therapeutic option for select patients with mitral regurgitation. The therapy has the potential to transform the lives of thousands of patients, and enable some to go from bed rest to a more active lifestyle.”