Developed for the treatment of mitral valve stenosis, the Inoue-Balloon Catheter is indicated for Percutaneous Transvenous Mitral Commissurotomy (PTMC) in patients with hemodynamically significant mitral valvular stenosis, resulting primarily from commissural fusion of the mitral valve cusps. Published date from observational and randomized studies have provided evidence that physicians should consider PTMC as a treatment choice for patients with favorable valve anatomy. (1),(2),(3) The PTMC procedure is one of several methods for treating symptomatic mitral stenosis. Alternative methods which may be considered include: medical therapy, surgical commissurotomy, mitral valve repair and mitral valve replacement.
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CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN TRAINED OR EXPERIENCED IN THE USE OF THIS DEVICE.
CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS.