EVALVE LAUNCHES PIVOTAL TRIAL OF PERCUTANEOUS ALTERNATIVE TO OPEN-HEART MITRAL VALVE SURGERY

Evalve has initiated a pivotal study to demonstrate the safety and efficacy of its MitraClip percutaneous valve repair system for patients with mitral regurgitation (MR).

The Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) II trial is a randomized, multicenter study comparing the MitraClip technique to standard surgical mitral valve repair or replacement in patients with functional or degenerative MR. Approximately 30 medical centers across North America will be participating in the study.

To qualify for the EVEREST II trial, patients must have a weakened left ventricle, or have moderate-to-severe MR and be experiencing symptoms (fatigue, chest pain, or shortness of breath).

During the procedure, a catheter is introduced through the patient's skin in the groin area and is then guided through the femoral vein into the affected area of the heart. A smaller delivery catheter that holds the MitraClip is then introduced through this tube so that the clip can be guided into place and attached to the leaflets (the "swinging doors") of the mitral valve. Once the clip is securely attached, it is deployed and the catheters are removed.