Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm² and/or mean transmitral gradient ≥10 mmHg at normal heart rate) per American Society of Echocardiography criteria.
LVEF ≥ 30%
In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.
You may not be if
Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.