Evalve, a developer of devices for the percutaneous repair of cardiac valves, has received the CE Mark approval for its MitraClip system, which enables a non-surgical option for patients suffering from the effects of mitral regurgitation (MR).
MR is the most common type of heart valve insufficiency in the U.S. and the second most common in Europe. Both in the U.S. and Europe, the majority of patients are untreated, which leaves their hearts affected by the chronic volume overload caused by MR, requiring the heart to work harder, and ultimately leading to heart failure, Evalve said.
Percutaneous mitral repair with its MitraClip device is performed by interventional cardiologists in the catheterization laboratory, according to the Menlo Park, Calif.-based Evalve.
The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly, the company said.