First-In-Class MitraClip Device

Abbott officials announce that its first-in-class, catheter-based MitraClip therapy has received U.S. Food and Drug Administration (FDA) approval and will launch immediately in the United States, providing physicians with a breakthrough treatment option for patients suffering from mitral regurgitation (MR). The 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.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.

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. More than 11,000 patients in more than 30 countries have been treated with 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

"FDA approval of MitraClip marks an important milestone for Abbott as we continue to bring forward innovative therapies to help patients live better lives," says Chuck Foltz, senior vice president, vascular, Abbott. "We look forward to making this technology available to specialized centers in the U.S. 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."

Abbott continues to conduct clinical trials of the MitraClip therapy through two landmark, prospective, randomized trials – COAPT in the United States and RESHAPE-HF in Europe – that will evaluate the impact of MitraClip treatment on the progression of heart failure. The studies also will generate important clinical and economic data that may support development of treatment guidelines, expanded indications, and reimbursement. Both studies are currently enrolling patients.

Source: Abbott

^{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.}