MitraClip Information

What is MitraClip™ Therapy approved for? MitraClip therapy is a minimally invasive procedure approved for treating patients with clinically significant mitral regurgitation due to either (a) a deteriorated mitral valve but the patient is at very high risk for surgery, or (b) an improperly functioning mitral valve resulting from heart failure, with poor pumping of the blood by an enlarged heart, and who have reached maximal tolerance to medications. Patients should work with their doctor and a multidisciplinary heart team, which should include a heart surgeon and cardiologist with experience treating heart failure, to confirm their surgical risk or optimal medications. The heart team will determine if the patient meets the indications for the MitraClip procedure. Who should not have the MitraClip Procedure? Patients that have any of the following conditions should not have the MitraClip Procedure: inability to tolerate or are allergic or hypersensitive to anti-coagulants, anti-platelet therapies, nickel, titanium, cobalt, chromium, polyester, or contrast dye; have inflammation or rheumatic disease of the valve; or have blood clots inside the heart or blood vessels (inferior vena cava, femoral vein). What can happen to me during the MitraClip Procedure? As with most medical procedures, MitraClip placement has risks, including inappropriate device placement, device movement from its implanted site, and failed or difficult delivery or retrieval of the device once implanted. Your physician will determine if you fall within the labeled indication for the MitraClip Procedure. Who is more at risk during the MitraClip Procedure? Even though MitraClip Therapy is a minimally invasive medical procedure, it carries risks, and some patients may be at a higher risk than others. If you have either a weak heart that may need support during the procedure or a rotated heart from prior heart surgery, talk to your doctor to weigh the additional risks to the benefits of the MitraClip procedure as the safety and effectiveness has ...