Positive clinical results for MR reduction device

SAN FRANCISCO -- Abbott (NYSE: ABT) has announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the company's first-in-class catheter-based MitraClip System for the treatment of mitral regurgitation (MR).  Findings were presented today at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco.

Mitral regurgitation (MR) is the most common type of heart valve insufficiency^[1] affecting approximately one in 10 people aged 75 years and older. The condition occurs when the leaflets of the mitral valve do not close completely, causing blood to flow backward and leak into the left atrium of the heart during the cardiac cycle. To maintain an adequate forward flow of blood throughout the body, the heart compensates by increasing the size of the left ventricle, its main pumping chamber. This requires the heart to work harder, and may ultimately lead to irregular heartbeats, stroke, heart attack or death.  MR may also lead to heart failure, a potentially deadly condition that occurs when the heart is unable to pump sufficiently to distribute blood flow to meet the needs of the body.

The EVEREST II High Surgical Risk cohort included data from patients enrolled in the multi-center EVEREST II High Risk and REALISM continued access studies. Findings from 351 symptomatic U.S. patients deemed too high risk for open mitral valve 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);

— A low rate of adverse events, despite the high surgical risk profile of the patients

— An implant success rate of 96%;

Chuck Taylor All Star