MiCardia Corporation received European CE Mark of approval for its enCorSQ Mitral Valve Repair System, an adjustable annuloplasty ring for patients with dilated MV (Carpentier type I MR).
The device is intended to address residual post-op mitral regurgitation by providing an ability to change the shape of the valve annulus months after initial implantation via a minimally invasive procedure. By stimulating a subcutaneous lead, the surgeon can trigger the ring to change its shape and approximate anterior-posterior distance of the mitral valve. The company also says that it’s been developing a trans-catheter delivery device for its adjustable ring that will provide the capability to implant the mitral annuloplasty device interventionally, without the need for surgery.
The MiCardia enCorSQ Mitral Valve Repair System is a mitral repair device with a permanently attached lead and a proprietary energy source, the MC-100 RF generator. The enCorSQ is constructed using a memory shape alloy core that has been designed to change its shape when its temperature is elevated a few degrees above body temperature. The device is implanted on the mitral annulus and the permanent lead is tunneled through the atrial wall and implanted under the skin in the chest or abdominal cavity.
If mitral regurgitation recurs, days to months after the initial procedure, the permanent lead is exposed in a minimally invasive manner, using a cut-down. The lead is then connected to its energy source, the MC-100. The shape of the device is changed, thereby reducing the anterior posterior distance of the mitral valve and eliminating or minimizing the recurrent regurgitation.