Chronic heart failure (HF) is prevalent (affecting > 2% of the US adult population, more than 6.2 million), increasing nationally and globally, with high morbidity and mortality, and with high economic burden. Two common phenotypes are heart failure with reduced left ventricular ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF). Both are characterized by neurohormonal dysregulation, the latter with progressive chamber and functional deterioration. Several available therapies improve survival and functional status of chronic heart failure with reduced ejection fraction (HFrEF). There are no approved therapies (pharmacologic or device) for HFpEF. Both HFpEF and HFrEF often manifest secondary or functional mitral valve regurgitation that is thought to contribute to morbidity, heart failure hospital admission, and mortality. Morbidity and mortality remain high, and ample opportunity remains for new therapies to treat or retard the progression of both.
Transmural Cerclage Mitral Annuloplasty
Transmural Cerclage™ is a non-surgical treatment for secondary mitral regurgitation associated with chronic heart failure, whether HFrEF or HFpEF. The cerclage procedure applies extrinsic compression around the mitral valve annulus and left ventricular outflow tract in a simple right-sided (“venous”) transcatheter procedure. These features of cerclage have the proposed effects (1) of reducing the dimensions of the mitral annulus to enhance leaflet coaptation and reduce mitral regurgitation; (2) of enhancing myocardial performance by reducing left ventricular radius and wall stress, and; (3) by attenuating exercise-induced mitral regurgitation accounting for heart failure symptoms, by imposing reciprocal constraint on the mitral-LVOT complex.
Transmural Cerclage™ is approved by the FDA as an investigational device for early feasibility study.