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Cardiac Dimensions Launches IDE Trial of Carillon Mitral Repair System

Executive Summary

The double-blind CARILLON trial will compare mechanical repair of functional mitral valve regurgitation with medical therapy alone in 400 patients at about 50 sites. The company is already running the REDUCE FMR randomized trial outside the US.

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Results of the 120-patient, sham-controlled REDUCE FMR trial showed Cardiac Dimensions Carillon device can significantly reduce mitral regurgitation and left ventricular volume in patients with symptomatic functional mitral regurgitation.

Market Intel: Relentless Rise Of Transcatheter Tech: Heart Valve Repair Turns Back On Open Surgery

The global market for products treating heart valve disease is expected to exceed $8bn by 2021, driven largely by the rising number of elderly patients with cardiovascular disease, obesity and growing prevalence of diabetes. This, in turn, is fueling significant innovation in minimally invasive techniques, particularly in the leading area of transcatheter aortic valve replacement (TAVR), but also in transcatheter mitral valve repair (TMVrep) systems, both of which offer patients quicker recovery times, less discomfort and greater safety compared to traditional surgical heart valve repair and replacement. This feature looks more closely at the competitive landscape and dynamics of these two fast-growing market segments, as well as gives insight into what the users – the physicians – think of these technologies.

Medtechs Bet On Transcatheter Mitral Valve Repair

The success of transcatheter aortic valve replacement has generated optimism that the much larger pool of mitral regurgitation patients can be similarly served. While big strategics bet on replacement, however, other companies are betting on repair, developing less invasive devices inspired by an array of established mitral valve surgical repair techniques.

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