Mechanical Solution for a Mechanical Problem
Evalve transformed an existing open-chest arrested-heart surgical procedure, known as the Alfieri technique (edge-to-edge mitral valve repair), into the percutaneous catheter-based procedure. With the Alfieri technique, the surgeon sutures the leaflets together at the point of the leak in the valve. By doing this, closure of the valve is facilitated, which reduces MR. The valve continues to open and close on either side of the sutures, allowing normal forward blood flow.
The MitraClip device mimics the Alfieri technique although much less invasively using a catheter system that is inserted into the femoral vein. The MitraClip device, located at the end of the delivery catheter, is used to grasp the leaflets of the mitral valve while the heart is fully functional and beating. Once the clip is attached to the leaflets, the clinician is able to assess real-time whether the reduction in regurgitation is adequate. If the physician is not satisfied with the result, the clip can be repositioned to improve the result. This step of the procedure can be repeated until the physician is satisfied with the final result, at which time the clip is deployed on the leaflets.
Moving Toward Commercialization
Evalve obtained CE Mark approval for the MitraClip system in March 2008, and is now establishing a sales organization and training programs needed to start sales in Europe. In North America, Evalve is continuing the phase II pivotal study and expects to complete enrollment in that study by the end of 2008. Allowing time for the required patient follow- p, analysis of the data, and the Food and Drug Association (FDA) review process, Evalve is currently expecting commercial approval in the US by he end of 2010.
Evalve has invested significant resources to train both interventional cardiologists and echocardiologists. Training includes time on-site with the physicians reviewing the MitraClip system and the important echocardiographic images used during the procedure.
Evalve is the only company that has initiated and completed more than 80% of enrollment in a phase II pivotal study of percutaneous mitral repair. In addition, Evalve is the only company that has successfully completed a feasibility study in the US and received CE Mark approval for a percutaneous mitral repair system.