INOUE-BALLOONBalloon Mitral Valvuloplasty Catheter

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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.

Licensed physicians should contact Toray International America Inc. (Toray’s U.S. distributor) for more information about Toray’s products.

PATIENTS ARE ADVISED TO CONSULT WITH THEIR PHYSICIAN CONCERNING ANY QUESTIONS ABOUT TORAY’S PRODUCTS

  1. (1) Lau KW, Ding ZP, Hung JS. Percutaneous Inoue-Balloon Valvuloplasty in Patients with Mitral Stenosis and Associated Moderate Mitral Regurgitation. Cathet Cardiovasc Diagn 1996, 38:1-7.
  2. (2) Reyes VP, Raju S, Wynne J, et al. Percutaneous balloon valvuloplasty compared with open surgical commissurotomy for mitral stenosis. New England Journal of Medicine 1994, 331:961-967.
  3. (3) Feldman T, Carroll JD. Percutaneous balloon mitral commissurotomy; When? For whom? J Critical Illness 1991, 6(10): 1009-1027.

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.

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