Vascular brachytherapy firm Novoste has received Food and Drug Administration approval for an investigational device exemption supplement. The change would permit patient enrollment in a clinical trial pursuing new applications for the company's Corona brachytherapy source system.
The randomized, multicenter trial will investigate the use of Corona to treat venous outflow stenosis in arterial-venous dialysis grafts, according to the Norcross, GA-based developer.
The modifications allow physicians to treat patients with thrombosed grafts, and change the primary endpoint of the trial when primary patency (the absence of re-intervention) occurs at three months. Prior to the modification, the endpoint had been successful measured dialysis flow at six months. The approved number of patients for the trial has also been reduced from 230 to 215, according to the firm.
By AuntMinnie.com staff writersFebruary 26, 2003
Related Reading
Novoste shows downturn in 2002, February 6, 2003
Novak tapped as Novoste president and CEO, October 17, 2002
Copyright © 2003 AuntMinnie.com
