The system minimally invasive MitraClip r Abbott for the treatment of mitral regurgitation demonstrates positive clinical results and improvements in the quality of life of patients with surgical risk too high.

System Abbott’s MitraClip, a device which is under investigation in the United States and which received the CE mark in 2008, is marketed in approximately 30 countries and, to date, has been used to treat more than 8,000 patients. The device reaches the heart through the femoral vein — a blood vessel from the leg — and is designed to minimize the IM joining the veils of the mitral valve so that it allows to the heart pump blood more effectively.

The cohort of high surgical risk of the EVEREST II study included data from patients who came from those included in the multicenter clinical research of continued access EVEREST II of high risk and REALISM. The analyzed results of the 351 symptomatic patients with high risk for open surgery of the mitral valve, showed:

-a mortality rate 30 days significantly reduced in comparison with the planned surgery (4.8% in patients treated with the MitraClip system compared with 18.2% of planned surgical mortality(, p < 0.0001).

-a low rate of adverse events, despite the surgical profile of high-risk patients.

-A success rate of the implant of the 96%.

-a sharp reduction of the IM to 2 + or less in 86% of patients treated with the MitraClip. device

-a clinically significant improvement in left ventricular size, functional class NYHA and the quality of life of the SF-36 and significantly reduced rates of hospitalization for heart failure (reduction scores(n of 48% one year after discharge, compared with the year prior to treatment, p < 0.0001).

“Mitral insufficiency patients who are not candidates for surgery of the mitral valve with mortality risk, do not have a therapeutic option that reduce symptoms and improve your quality of life,” explains Dr. Scott Lim, M.D., Assistant Professor of Cardiovascular Medicine at the University of Virginia Health System in CharlottesvilleYou will. “The results of the EVEREST II clinical research in the cohort of high surgical risk suggest that treatment with the MitraClip device represents a new option that would let these high-risk patients resume activities you enjoy and would imply a reduction in hospital admissions for heart failure.”

“These results are added to the increased and extensive data showing that MitraClip, best percutaneous treatment of its kind, can have positive results in patients at high surgical risk with debilitating symptoms produced by a significant mitral regurgitation,” says Charles A. Simonton, M.D., FACC, FSCAI, Vice President of Medical Affairs and Chief Medical Officer of Abbott Vascular. “We expect expectant meeting Advisory Comittee of the FDA, which will take place on March 20, to talk about system MitraClip as a therapeutic option for this group of patients in the United States.”

About mitral regurgitation

(IM) mitral regurgitation is the most common type of heart valve insufficiency, affects approximately one in every 10 people 75 years of age and over. The disease occurs when the leaflets of the mitral valve does not close completely, which reverses the flow of blood and passes to the left atrium of the heart during the cardiac cycle. To maintain adequate blood flow antegrade by the body, the heart compensates increasing the size of the left ventricle, the main pumping Chamber. This brings the heart to work harder and that in the end, irregular heartbeat, stroke, myocardial infarction or death may occur. The IM can also produce heart failure, a life-threatening condition that occurs when the heart does not have enough pumping capacity to distribute the blood flow and the needs of the body.

About the MitraClip system

Abbott’s MitraClip device is designed to reduce the IM and provide clinical and benefits of quality of life in patients with debilitating symptoms of significant IM, through the union of the mitral valve leaflets. The device goes to the heart through the femoral vein, a blood vessel in the leg. The heart beats normally during the procedure, so it is not necessary to resort to no cardiopulmonary bypass machine. Reducing the IM, treatment helps the heart recover from the overload and improve function, potentially stopping the progression of heart failure and allowing patients to improve their quality of life.

The device received the CE mark in 2008, sold approximately in 30 countries and to date, has been used to treat more than 8,000 patients. Guidelines for 2012 of heart failure of the European society of Cardiology (ESC) and for the treatment of cardiac valve disease in the European ESC/Association of cardiothoracic surgery backed by using the MitraClip as a therapeutic option for patients at high surgical risk with IM.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac care and vascular with leading products in the industry and leading products in research. Abbott Vascular offers a full portfolio of cardiac and vascular devices, including products for diseases of the coronary arteries occlusion of vessels, pathology endovascular and structural heart disease.

About Abbott

Abbott is an international biomedical company dedicated to improving the lives of people through the development of products and technologies covering all health care. With a portfolio of brands in diagnostic, medical, nutritional, and pharmaceutical products, Abbott attends to people in more than 150 countries and employs approximately 70,000 people.

In Spain, Abbott has more than 1,000 employees working in research and development, production, logistics, marketing and sales. With headquarters in Madrid, Abbott has also in Granada a centre of research and development into nutrition and medical nutrition products production plant, and Alcobendas has a plant of ophthalmology.