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IVT CUTTING BALLOON IS NOT APPROVABLE BASED ON ANGIOPLASTY EQUIVALENCE DATA, FDA PANEL CONCLUDES; FIRM WILL CONTINUE RESTENOSIS REDUCTION STUDY

This article was originally published in The Gray Sheet

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Executive Summary

InterVentional Technologies plans to refocus on demonstrating the potential benefits of the Barath surgical dilatation balloon in reducing coronary artery restenosis as it continues clinical studies of the product. On March 4, FDA's Circulatory System Devices Panel unanimously (8-0) recommended against approval of the device, which is also known as the Cutting Balloon, based on data that attempted to show equivalence to standard balloon angioplasty for coronary artery dilatation.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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