Results Show Treatment Provides Clinical Benefits and Improves Quality of Life for Patients with Debilitating Mitral Valve Disease Who Are at Prohibitive Surgical Risk
ABBOTT PARK, Ill., Oct. 30, 2013 /PRNewswire/ -- Abbott today announced clinically meaningful changes to quality of life, a reduction in rehospitalization for heart failure, and functional improvements for patients treated with the company's first-in-class, catheter-based MitraClip® therapy for patients with degenerative mitral regurgitation (MR) who are at prohibitive risk for mitral valve surgery. Findings were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco and simultaneously published in the Journal of the American College of Cardiology.
The MitraClip device, which received U.S. Food and Drug Administration (FDA) approval last week, provides physicians with a breakthrough treatment option for patients suffering from MR. The MitraClip device is now available in the United States for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. Degenerative MR is a type of MR caused by an anatomic defect of the mitral valve of the heart. Prohibitive risk is determined by the clinical judgment of a heart team due to the presence of one or more surgical risk factors.
"The results of this study show that, even for some of the most ill and debilitated patients, the MitraClip system is safe and results in good clinical outcomes," said D. Scott Lim, M.D., associate professor of Cardiovascular Medicine at the University of Virginia Health System in Charlottesville, Va., and lead author of the publication. "These prohibitive-risk patients have had, until now, no approved therapies to improve the quality of their lives."
Data from 127 patients with degenerative MR at prohibitive surgical risk treated with the MitraClip device demonstrate:
- Clinically meaningful changes to quality of life. Following MitraClip treatment, changes in SF-36 summary scales (a quality-of-life survey) were well above established thresholds showing minimum clinically important differences.
- A reduction in rehospitalization for heart failure of 73 percent.
- Functional improvements, with 76 percent of patients with baseline NYHA Functional Class III improving to NYHA Functional Class I or II, and 65 percent of patients with baseline NYHA Functional Class IV improving to NYHA Functional Class I or II.
- Favorable ventricular remodeling, with left ventricular end-diastolic and end-systolic volume decreased significantly at one year compared with baseline.
- A majority of patients discharged to home (87 percent), rather than to nursing care.
Findings were presented during the TCT conference by 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.
"These positive results, which were reviewed as part of the totality of data from Abbott's FDA submission, along with clinical results from more than 2,200 patients treated with the device, confirm the benefit of the innovative MitraClip therapy for this very sick patient population," said Chuck Foltz, senior vice president, vascular, Abbott. "This year's TCT conference has been particularly exciting for Abbott, with enormous enthusiasm about MitraClip from clinicians in the United States and around the world, and more than 65 presentations highlighting data related to the therapy."
Multiple trials, published reports, and registries of patients treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms, and reduction in hospitalizations for heart failure, even in some of the most ill and debilitated patients.
About Mitral Regurgitation
Mitral regurgitation is a debilitating, progressive and life-threatening disease in which a leaky mitral valve causes a backward flow of blood in the heart. The condition can raise the risk of irregular heartbeats, stroke, and heart failure, which can be deadly. Mitral regurgitation is common, affecting more than 4 million Americans – nearly one in 10 people aged 75 and above.1 Open heart mitral valve surgery is the standard of care treatment, but many patients are at prohibitive risk for an invasive procedure. Medications for the condition are limited to symptom management and do not stop the progression of the disease.
About the MitraClip Device
Abbott's MitraClip repairs the mitral valve without the need for an invasive surgical procedure. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and once implanted, allows the heart to pump blood more efficiently, thereby relieving symptoms and improving patient quality of life. Patients undergoing MitraClip treatment typically experience short recovery times and short hospital stays of two to three days.2 More than 11,000 patients in more than 30 countries have been treated with the MitraClip device.
About Abbott Vascular
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 (NYSE: ABT) is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.
1 Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. http://www.ncbi.nlm.nih.gov/pubmed/16980116
2 Data on file at Abbott; Rogers, JH, Franzen, O. Percutaneous edge-to-edge MitraClip therapy in the management of mitral regurgitation. European Heart Journal (2011) 32, 2350–2357.
Additional information about MitraClip, including important safety information, is available at http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/structural_heart/eIFU_MitraClip.pdf