Abbott's Investigational MitraClip(R) System Demonstrates Strong Safety Results and Improved Clinical Outcomes for Common Causes of Leaky Heart Valves

PARIS, May 25 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today announced new data from the landmark EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) trial, which provide additional details about the safety and clinical benefit of Abbott's investigational MitraClip® system for the two causes of mitral regurgitation (MR) – functional MR (FMR) or degenerative MR (DMR). In the EVEREST II trial, the 30-day major adverse event rate in the MitraClip arm was similar for the FMR and DMR patient subgroups (8.2 percent for FMR patients, 8.1 percent for DMR patients), both lower than the surgical control group (42.6 percent). The MitraClip system also demonstrated consistent results in both FMR and DMR patients with both subgroups showing significant improvement at one year from baseline measures of heart function, symptoms and quality of life. These results were presented today during the Late Breaking Registries and Clinical Trial Updates session at the EuroPCR 2010 conference, and build upon the positive EVEREST II primary endpoint results that were presented during the American College of Cardiology 2010 meeting in March.

MR is the most common type of heart valve insufficiency and occurs when the leaflets of the mitral valve do not close completely, causing blood to flow backwards into the left atrium of the heart during the cardiac cycle. When patients are diagnosed with MR, they are usually classified as having functional MR or degenerative MR. Functional MR accounts for the majority of MR patients, and occurs due to heart muscle abnormalities caused by coronary artery disease or cardiomyopathy (a condition which causes the heart muscle to weaken). Degenerative MR is caused by deterioration of valve tissue.

Additionally, Abbott presented results on a subset of patients within the EVEREST II trial who had progressed to two years post procedure, which showed that the positive clinical results achieved at one year with the MitraClip system are sustained at two years in patients with significant MR. The preliminary two-year results evaluated 86 of the 217 patients who had successful MR reduction after treatment with a MitraClip device or open heart surgery, and showed there was no difference in the need for subsequent mitral valve surgery through two years between these two groups.

"The patient subgroup analysis shows that the catheter-based clip device delivers consistent results regardless of FMR or DMR etiology. These results are important because they are consistent with the results achieved in the EVEREST High Risk Registry Study, indicating the device may be an option for treatment for a range of patients with MR," 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, IL; and co-principal investigator of the EVEREST II trial. "In addition, the data on the durability of the clip device compared to surgery through two years adds to my confidence that a treatment strategy with the clip may be a viable choice for certain patients who are looking for other options to treat their leaky heart valve."

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 significant MR by clipping together the leaflets of the mitral valve (one of the four valves of the heart). Mitral regurgitation affects more than 8 million people in the United States and Europe and is currently managed with drugs or open heart surgery, depending on an individual patient's severity of MR and risk factors. Significant MR is a debilitating condition where the heart's ability to function continues to deteriorate over time, and may lead to irregular heartbeat, heart failure, stroke, heart attack or death.

"Continued advancements in medical device technology are bringing more options and tremendous benefits to patient care. The MitraClip device is a novel treatment, and these preliminary data indicate the device has sustained mid-term benefits and can be an option for some patients with FMR or DMR," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular.

The MitraClip system received CE Mark in March 2008. In the United States, the MitraClip device is limited by federal law to investigational use only and is not available for sale. The MitraClip system is currently under review for approval by the U.S. Food and Drug Administration.

More About the EVEREST II Patient Subgroup Analysis

The EVEREST II trial is the first randomized trial of any minimally invasive mitral valve repair device compared to mitral valve surgery. The EVEREST II pivotal trial is a multi-center, randomized clinical trial of 279 patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation who were candidates for mitral valve surgery. Patients were selected for treatment with the MitraClip device if they met the criteria for surgical intervention from the 1998/2006 American College of Cardiology (ACC)/ American Heart Association (AHA) Joint Task Force Recommendations regarding therapy for valvular heart disease.

The patient subgroup analysis included 135 patients with DMR and 49 patients with FMR. At one year, the MitraClip procedure demonstrated the following results in FMR and DMR patients:

• An improvement in heart function as indicated by a reduction in both left ventricular end diastolic volume (LVEDV) and left ventricular end systolic volume (LVESV). In FMR patients, LVEDV decreased 10.6 percent and LVESV decreased 7.7 percent compared to baseline. Similarly, in DMR patients, LVEDV decreased 15 percent and LVESV decreased 6.7 percent compared to baseline.
• An improvement in symptoms, with 96.7 percent of FMR patients and 97.8 percent of DMR patients exhibiting no symptoms (NYHA Functional Class I) or mild symptoms (NYHA Functional Class II), whereas at baseline, 64.5 percent of FMR patients and 45.2 percent of DMR patients had moderate symptoms (NYHA Functional Class III) or severe symptoms (NYHA Functional Class IV). Patients who are classified as NYHA Functional Class III or IV experience marked or severe limitations in physical activity.
• Meaningful improvements in both physical and mental quality of life compared to baseline as measured by the SF-36 Survey (increase of 1.6 points for FMR patients and 5.6 points for DMR patients in the physical quality of life score, and increase of 8.7 points for FMR patients and 5.0 points for DMR patients in the mental quality of life score).

About Mitral Regurgitation

MR is the most common type of heart valve insufficiency in the United States and Europe, affecting millions of people worldwide. MR affects more than 8 million people in the United States and Europe. There are more than 600,000 new diagnoses of significant MR each year in the United States and Europe; however, only about 20 percent of these patients undergo surgery each year. While many patients are either higher-risk surgical patients or not sick enough for surgery, approximately 80 percent of patients with MR continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, and may ultimately lead to heart failure and other complications.

About the MitraClip Technology and Procedure

Abbott's proprietary MitraClip system is used for catheter-based mitral valve repair in patients suffering from the effects of mitral regurgitation. Mitral valve repair with the MitraClip system is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. After treatment, patients have been observed to recover quickly. The MitraClip system is intended to provide another treatment option in the existing continuum of care, including medical management and open, arrested heart surgical options. The MitraClip device may help MR patients avoid or delay surgery.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.  The company employs approximately 83,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

SOURCE Abbott