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Novoste (US) to test novel catheter system

This article was originally published in Clinica

Executive Summary

Novoste (US) has received an IDE to perform a US feasibility study of its intracoronary beta-irradiation catheter system for the prevention of post-angioplasty restenosis. The Norcross, Georgia-based company believes this is the first such approval from the FDA. The Novoste system is intended to be used immediately following balloon angioplasty. It delivers beta-radiation to the site of an intervention to inhibit neointimal hyperplasia thereby reducing the incidence of restenosis. Novoste says it will take just a few minutes to perform the procedure.

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