Novoste enlarges Beta-Cath brachytherapy trial:
This article was originally published in Clinica
Executive Summary
Novoste is to enlarge the US trial of its Beta-Cath brachytherapy treatment for restenosis, after enrolling the 386 patients needed ahead of schedule. The Norcross, Georgia-based company now expects around 450 patients to take part in the eight-month Stents and Radiation Therapy (START) trial. Allowing time for patient follow-up and data analysis, Novoste expects to submit the data for US marketing approval of Beta-Cath to the FDA in the second quarter of 2000.