NORCROSS, Ga., Jun 21, 2002 (BW HealthWire) —
Novoste Corporation (Nasdaq: NOVT) today announced that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to begin its BRAVO (Beta Radiation for treatment of Arterial-Venous graft Outflow) clinical trial.
Over 200,000 people in the U.S. currently undergo long-term dialysis for end stage renal disease and a majority of these patients rely on arterial-venous dialysis grafts for vascular access. Unfortunately, these grafts are associated with a very low patency rate of 40 – 60% at one year and patients often require interventional therapy to maintain patency.
There is evidence that the low patency rate is due to proliferation of cells (stenosis) at the graft site and early clinical data using intravascular radiation in this application suggests that this technology may play a significant role in improving patency rates. The BRAVO trial is a prospective, randomized, multi-center, placebo-controlled trial investigating the safety and efficacy of the Novoste(TM) CORONA(TM) System to treat venous outflow stenosis in arterial-venous dialysis grafts. Approximately 230 patients will be enrolled at over 20 centers in North America and Europe.
e-Med Tools
קצר קולע וממוקד
e-Med סמינרים
אי-מד תחקירים
Medscape Tools
Journal Club
מרכזי מידע ושירות
Facebook
מידע למפרסם
מאגר תרופות
מאגר אנשי המקצוע
אינדקס שימושי
חדשות משה"ב
eMed HealthClub
מחקרים קליניים
השאירו תגובה
רוצה להצטרף לדיון?תרגישו חופשי לתרום!