MitraClip Enables Transcatheter Repair of the Mitral Valve

Abbott’s MitraClip approved for use in patients with significant degenerative MR who are a prohibitive risk for open mitral valve surgery

 

October 25, 2013
MitraClip, Abbott, transcatheter mitral valve repair, FDA approval

The MitraClip is the first minimally invasive, transcatheter device to repair mitral regurgitation (MR). The device is first of its kind to gain approval for use in patients in the United States and part of a new movement away from open heart surgical repair toward minimally invasive procedures performed in a cath lab or hybrid operating room.    Abbott said it plans to launch the device immediately in the U.S. market. 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. 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] 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. The U.S. Food and Drug Administration (FDA) has granted market clearance for the MitraClip in October 2013. For more information: www.abbott.com, www.abbottvascular.com/static/cms_workspace/pdf/ifu/structural_heart/eIFU_MitraClip.pdf

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