Technology
MITRAL BUTTERFLY
The Mitral Butterfly implant facilitates reconstruction of the mitral valve for mitral valve prolapse.
The advanced technology is based on product implantation via a transvascular catheter onto the compromised valve, with no need for open-heart surgery. The device is comprised of a nitinol stent and a polymer mesh and attached in the peri-annular region of the valve with a single clasp.
The polymer mesh covers the entire prolapsing segment and is extended to a swing arm in the ventricle, mimicking papillary muscle.
The mitral annulus remains unaffected and no unintentional forces strain the myocardium. Unlike monochordal repair, Mitral Butterfly can be deployed in one step and there is no need to connect chords to the myocardium or to adjust the size, length and orientation of individual chords.
Mitral Butterfly is mainly applied in case of posterior mitral valve prolapse but may also be used on anterior flail leaflets.
The implant can be placed directly on the malfunctioning valve’s leaflet in a one-step procedure, significantly reducing the burden for the patient and the time of intervention.
Currently, Mitral Butterfly is in the preclinical testing stage.
Proof of concept was verified using passively perfused porcine hearts with native valves and after manually cutting the chordae. Recently device performance was analyzed in chronic animals and in silico, showing good integration of the device with a normal effective orifice area and no gradient or regurgitation.
- one-step procedure
- no attachment to muscular structures due to artificial papillary muscle
- rapid transcatheter mitral valve repair
Background
MITRAL VALVE REGURGITATION
Heart valve disease occurs when one or more heart valves fail to open and close properly. This can affect the ability of the heart to pump blood. There are mainly two types of problems that can disrupt blood flow through the valves, namely, regurgitation (incompetence) or stenosis (narrowing).
Mitral valve regurgitation is defined as backflow (leaking) of blood from the left ventricle into the left atrium of the heart due to insufficient valve closure. It is often the result of aging or disease. Symptoms include light-headedness, shortness of breath, fatigue and chest pain.
While small leaks are usually not considered a problem, more severe cases weaken the heart over time and can lead to heart failure. Two percent of adults suffer from mitral regurgitation, while in over 75 years of age almost 10% of individuals are affected.
Mitral valve regurgitation can be either degenerative (DMR; caused by mitral valve prolapse due to elongation or rupture of chordae) or functional (FMR; secondary to left ventricular remodelling (change in ventricle size and shape) or atrial dilatation resulting in insufficient leaflet closure).