The Mitralign Percutaneous Annuloplasty System, MPAS, is intended for the treatment of symptomatic functional mitral regurgitation (MR ≥ 3+) for annular reduction through tissue plication.
The mitral valve controls blood flow from the left atrium to the left ventricle of the heart, allowing blood to flow in one direction through the heart and into the body. Referred to as mitral valve insufficiency or functional mitral regurgitation (FMR), it is the most common valve disease and occurs when the left ventricle of the heart is enlarged and stretches the valve opening. The valve leaflets are not able to come together and close properly, allowing blood to flow, or regurgitate, back into the atrium. Consequences can include heart failure or serious rhythm problems called arrhythmias. An estimated four million people in Europe and four million people in the United States have significant mitral valve insufficiency, also known as mitral regurgitation, with an annual incidence of 250,000.1 If left untreated, FMR overloads the heart which can lead to or accelerate heart failure.
The Mitralign® Percutaneous Annuloplasty System for functional mitral regurgitation is an innovative therapy that offers an alternative to more invasive, open chest surgery. It provides a fully transcatheter procedure that provides potential improvements to left ventricular remodeling and quality of life.
Advantages of the Mitralign Platform
- Based on a surgical predicate
- Extremely small footprint leaves a significant amount of native anatomy undisturbed
- Ability to customize location and plication distance in mitral annulus
- Front-line, flexible therapy allows for multiple treatment options in challenging anatomies
3 Main Steps of the Procedure
14 Fr guide catheter is positioned on the posterior side of the left ventricle, and two wires are placed in the mitral annulus.
Two pledgets are delivered across the annulus over the wire.
Plication and Lock
The pledgets are plicated (pulled together) and locked in place.
Procedure uses fluoroscopy for guidance
2D and 3D transesophageal echocardiography are used to confirm position
- Stuge O., Liddicoat J., et al. JTCS 2006;132:1258-61↑