Novoste Beta-Cath
This article was originally published in The Gray Sheet
Executive Summary
Smaller 3.5 Fr version of the intravascular brachytherapy catheter gains PMA supplement approval, announced Feb. 13. The smallest diameter catheter commercially available, the device can be used with a 6 Fr guiding catheter, the firm says. The system will allow treatment of restenosis in vessels too small for the current 5 Fr system. Both are available with 30 mm and 40 mm radioactive source trains. The Beta-Cath is installed in 340 U.S. hospitals and controls about 85% of the U.S. brachytherapy market (1"The Gray Sheet" Feb. 4, 2002, p. 17)...
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Novoste
Vascular brachytherapy device maker launches a third radiation source train for its Beta-Cath vascular radiation delivery system, the 60 mm in length, based on results of a 139-patient subset from the 1,098 patient RENO European registry. In this subset, the Beta-Cath reduced target vessel revascularization 75% versus the placebo group in the 94-patient LONG WRIST study. Average lesion length was 35.3 mm in RENO and 28 mm in LONG WRIST. Source trains of 30 mm and 40 mm also are available, in 5 Fr and 3.5 Fr diameters (1"The Gray Sheet" Feb. 18, 2002, In Brief)...
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