Abbott Laboratories (NYSE:ABT) said Monday that its catheter-based MitraClip system used to improve heart function proved durable after two years in patients with significant mitral regurgitation.
The study of 279 patients is the first to compare a mitral valve device to valve surgery. After two years, 78% of patients were free from surgery.
Dr. Donald Glower, a professor of surgery as Duke University School of Medicine, said the device demonstrated “strong safety and meaningful clinical benefits,” noting the results support its use as a treatment for patients who are considered high-risk surgical candidates.
The MitraClip, which is already approved in Europe, is inserted through a catheter placed in the patient’s leg. It clips together leaflets of the heart’s mitral valve to reduce significant mitral regurgitation, which occurs when the leaflets do not close all the way, causing blood to flow backward.
The most common type of heart valve insufficiency, mitral regurgitation affects more than 4 million people in the U.S. The condition weakens the heart’s ability to function, causing it to deteriorate over time and possibly leading to irregular heartbeats, heart failure, stroke, heart attack or death.
The medial device maker, which has announced similarly positive one year results for the same system, anticipates regulatory review in the U.S. this year.