Galileo PMA Submission Expected By Year-End; Early Review Possible
This article was originally published in The Gray Sheet
Executive Summary
Guidant plans to file a premarket approval application with FDA by the end of the fourth quarter for its Galileo beta-emitting intravascular brachytherapy system.
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Guidant
Firm launches 360-patient, 40-center LIMIT trial to evaluate its Galileo intravascular radiation system in treatment of long coronary lesions (up to 47 mm) in up to two coronary arteries. Data will supplement the recently completed 332-patient, 27-center INHIBIT trial, which will form the basis of the firm's PMA submission for the Galileo (1"The Gray Sheet" Nov. 20, 2000, p. 6). Competitor Novoste expects to submit a PMA supplement shortly for an expanded indication for its Beta-Cath radiation system to treat lesions up to 40 mm. Novoste also expects to complete its 1,500-patient Beta-Cath System trial evaluating patients with de novo lesions in time for the March 18-21, 2001 American College of Cardiology meeting in Orlando. Both Guidant and Novoste also intend to submit PMA supplements for the de novo lesion indication next year