Updated on 30 October 2013
Abbott's catheter-based MitraClip therapy gets US FDA approval for treating mitral regurgitation (MR)
Singapore: Abbott's catheter-based MitraClip therapy has received US FDA approval for providing physicians a treatment option for patients suffering from mitral regurgitation (MR).
MitraClip device has been approved 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 documented surgical risk factors.
MR 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. 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.
"As cardiac surgeons, we see patients with severe mitral regurgitation who we can technically operate on but who are just too frail or sick to survive mitral valve surgery with a reasonable risk and quality of life," said Mr Michael Mack, director, cardiovascular research and cardiovascular medicine and director of cardiovascular surgery at Baylor HealthCare System in Dallas, US. "With the MitraClip system, heart teams now have a catheter-based, less-invasive treatment option that can help patients who cannot withstand surgery regain their quality of life.
"MitraClip is a breakthrough in the treatment of severe mitral regurgitation, a condition that is progressive and causes extreme fatigue and shortness of breath, eventually making even simple tasks virtually impossible, and increasing the risk of stroke, heart failure and death," said Dr Ted Feldman, director, Cardiac Catheterization Laboratory.
"FDA approval of MitraClip marks an important milestone for Abbott as we continue to bring forward innovative therapies to help patients live better lives," said Mr Chuck Foltz, senior vice president, vascular, Abbott. "We look forward to making this technology available to specialized centers in the US with multi-disciplinary teams experienced in the management of patients with heart valve disease, a model that facilitates dialogue across physician specialties and provides patients with the best treatment outcomes."