Abbott, a global healthcare company, announced publication of positive outcomes from two European post-approval studies of the first-in-class catheter-based MitraClip therapy for the treatment of mitral regurgitation (MR). The positive results are from ACCESS-EU, a European prospective study that enrolled 567 patients at 14 sites, which have been published in the Journal of the American College of Cardiology.
In addition, findings of the investigator-sponsored German TRAnscatheter Mitral Valve Interventions (TRAMI) registry, which enrolled 1,064 patients at 20 German sites, were recently published in EuroIntervention.
Abbott's MitraClip System, which received CE Mark in 2008 and is commercially available in Europe and other international markets, is an investigational device in the United States. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together a portion of the leaflets of the mitral valve to allow the heart to more efficiently pump blood.
Data from ACCESS-EU demonstrated that in real-world, post-approval experience in Europe, patients undergoing the MitraClip therapy are predominantly high surgical risk, elderly patients who are mainly affected by functional MR, a type of MR in which a damaged heart impairs the performance of a normal mitral valve. ACCESS-EU showed that in this patient population, the MitraClip procedure demonstrated low rates of hospital mortality and adverse events and provided significant improvements in day-to-day quality of life at one year following treatment.
"I am impressed by the excellent outcomes observed in real-world patients with the MitraClip therapy. The procedure proved safe and effective even in patients who are at high risk for complications from mitral valve surgery," said Francesco Maisano, MD, director of Transcatheter Valve Therapies at San Raffaele Hospital in Milan, Italy, lead author of the ACCESS-EU data publication and co-principal investigator of the study. "In my experience, the MitraClip therapy has a definite role for patients who are not candidates for surgery. I have treated many patients who have experienced a dramatic improvement in quality of life. Relief from the symptoms of mitral regurgitation has allowed many bedridden patients to return to normal day-to-day activities."
"The data from these studies, which together evaluated more than 1,600 patients, add to the clinical evidence confirming positive results for treatment with MitraClip in high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation," said Charles A Simonton, MD, FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The MitraClip device represents a true advance for these patients, who suffer from poor quality of life and have no satisfactory options to reduce their significant mitral regurgitation."
Mitral regurgitation (MR) is the most common type of heart valve insufficiency,and 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, the main pumping chamber of the heart. 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.
Abbott's MitraClip therapy is designed to reduce MR and provide clinical and quality-of-life benefits for patients suffering from the debilitating symptoms of significant MR by clipping together a portion of the leaflets of the mitral valve. The device is delivered to the heart through the femoral vein, a blood vessel in the leg. The heart beats normally during the procedure, and a heart-lung bypass machine is not required. By reducing MR, the therapy may allow the heart to recover from overwork and improve function, potentially halting the progression of heart failure and enabling patients to live a higher-quality life.
Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare.