|Now approved by FDA, the MitraClip has been used in patients in 30 other countries.|
Abbott landed FDA approval for its MitraClip cardiac device. The company's latest approval came after a series of significant setbacks including a lackluster endorsement from a regulatory panel several months ago, mixed study results, and an overseas safety warning. The device is on the market in Europe and patients in more than 30 countries have received the MitraClip, according to Abbott.
As of now, MitraClip is available for patients suffering from significant degenerative mitral regurgitation who do not qualify for traditional mitral valve surgery. Mitral regurgitation is caused by a leak in a patient's heart valve. If left uncorrected, this issue can cause blood to flow backwards through the heart, leading to irregular heartbeats. In some cases, mitral regurgitation can increase the risk of heart failure or stroke.
The MitraClip is designed for delivery through a patient's femoral artery and can clip together parts of a leaking mitral valve.
In total, Abbott states that 11,000 patients in more than 30 countries have been treated with the device. In addition, the company notes that a European study shows that the system demonstrates safety and efficacy for the treatment of mitral valve regurgitation. Earlier this year, a 48-month study, dubbed EVEREST II, showed that patients who received the MitraClip required follow up corrective operations and did not benefit over patients who received traditional mitral valve surgery. In addition, the device faced a safety warning earlier this year over issues with the MitraClip knob.