MiCardia Corporation announced that it has received CE mark approval for its enCorSQ mitral valve repair system. The enCorSQ device is surgically implanted to treat mitral regurgitation and enables physicians to adjust it without another surgery to correct any recurrent mitral valve regurgitation that may occur due to the progressive nature of the underlying cardiovascular disease.
The adjustment can be achieved, weeks to months post implantation without the need for a repeat high risk surgical procedure. In the European Union, approximately 20,000 mitral valve repair procedures are performed annually. Up to 30% of those patients will experience recurrence of mitral valve regurgitation. To the company’s knowledge, the enCorSQ mitral valve repair system is the only device available that can correct recurrent regurgitation without further surgical procedures.
“The MiCardia enCorSQ mitral valve repair system is a leap forward in the surgical treatment of severe mitral regurgitation. It provides patients with a unique advantage that no annuloplasty ring does. Upon recurrent mitral regurgitation, in months following otherwise successful surgery, the MiCardia device can be activated in vivo resulting in a shape change of the device to treat recurrent regurgitation in a minimally invasive manner, avoiding often complex redo surgery,” said Maurice Buchbinder, MiCardia’s chief medical officer.
About enCorSQ mitral valve repair system
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 minimising the recurrent regurgitation.
The enCorSQ mitral valve repair system is not currently available for sale in the USA.