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Guidant submits Galileo system to FDA:

This article was originally published in Clinica

Executive Summary

Guidant has filed a PMA application with the US FDA for its intravascular radiotherapy system for preventing the recurrence of blockages in coronary arteries. The Galileo system is a fully automated device that advances, through a catheter, a source wire containing the radioisotope phosphorus 32 into the treatment area. A precise dose of beta radiation is then delivered to the exact area for a predetermined period of time. Guidant's announcement of its PMA submission comes just weeks after the agency approved the first two intravascular radiation devices for treating in-stent restenosis - Cordis' Checkmate and Novoste's Beta-Cath.

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