MR patients treated with Abbott MitraClip system demonstrate clinical benefits of initial treatment at two years

Abbott (NYSE: ABT) today announced data from its EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) study showing that patients with significant mitral regurgitation (MR) treated with the company's investigational percutaneous catheter-based MitraClip® system continue to demonstrate the clinical benefits of initial treatment shown at one year out to two years, including improvements in heart function and reductions in symptoms. EVEREST II is the first randomized clinical trial to compare a catheter-based mitral valve device to mitral valve surgery. Data from the study were published in The New England Journal of Medicine and presented in a late-breaking clinical trial session at the American College of Cardiology's (ACC) 60th Annual Scientific Session and i2 Summit 2011 in New Orleans.

At two years after treatment, data from 279 patients from the EVEREST II trial demonstrated a clinical success rate of 51.7 percent for patients treated with the MitraClip device compared to a clinical success rate of 66.3 percent for surgery patients.

In The New England Journal of Medicine, the study authors, who represent a variety of specialties including cardiac surgery and interventional cardiology, state that "although percutaneous repair was less effective at reducing mitral regurgitation than surgery before hospital discharge, at 12 and 24 months the rates of reduction in mitral regurgitation were similar, and percutaneous treatment was associated with increased safety, improved left ventricular dimensions, and clinical improvements in NYHA class and quality of life."

"These results reinforce that the MitraClip device continues to be effective out to two years, confirming the durability of the clinical benefit and the safety profile of the therapy. Surgery also performed well in the trial," said Ted Feldman, M.D., FSCAI, director, Cardiac Catheterization Laboratory, and The Mr. and Mrs. Charles R. Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem, Evanston, Ill. "The MitraClip system offers an option that addresses the unmet need for a percutaneous approach to treating MR, which may be especially important for many patients who are considered high-risk surgical candidates."

Dr. Feldman served as co-principal investigator of the EVEREST II trial, was the lead author of The New England Journal of Medicine publication, and presented the two-year EVEREST II data during the late-breaking clinical trial session at ACC.

"In the EVEREST II study, the MitraClip device demonstrated strong safety and meaningful clinical benefits," said Donald Glower, M.D., professor of surgery, Cardiovascular and Thoracic Surgery Division, Duke University School of Medicine, Durham, N.C., co-principal investigator of the EVEREST II trial and an author of The New England Journal of Medicine publication. "The MitraClip system's positive risk-benefit profile supports its use as a treatment choice for patients who are not good candidates for surgery and have few other options, including elderly or frail patients, those who are at high risk for surgery, and certain patients with functional MR."

The MitraClip system includes a catheter-based device that is delivered to the heart through the femoral vein, a blood vessel in the leg. The MitraClip therapy is designed to reduce significant MR by clipping together the leaflets of the mitral valve, one of the four valves of the heart.

The most common type of heart valve insufficiency, MR affects more than 4 million people in the United States – a prevalence of 11.7 percent of those aged 75 years and older.  Significant MR is a debilitating condition in which the heart's ability to function continues to deteriorate over time and may lead to irregular heartbeats, heart failure, stroke, heart attack or death. The condition traditionally has been managed with medications (which can relieve symptoms but do not address the underlying cause of the condition) or open-heart surgery.  Many people who suffer from MR are not treated surgically because they are not referred to surgery, are not sick enough, or are too frail for an invasive procedure.