A Medical Device Daily
Vasogen (Mississauga, Ontario) reported plans for a confirmatory study that would support an application for regulatory approval in the U.S. of its Celacade technology for the treatment of patients with NYHA Class II heart failure. The planned trial design indicates that as few as 300 patients could provide sufficient data to confirm the finding of the phase III ACCLAIM trial which demonstrated a 39% reduction in the risk of death or cardiovascular hospitalizations for the large pre-specified subgroup of 689 NYHA Class II heart failure patients.
Therapy using the Celacade technology targets the inflammation underlying chronic heart failure and other cardiovascular diseases. Inflammation is a normal response of the immune system to cellular injury caused by infection, trauma, or other stimuli. During an outpatient procedure, a small sample of a patient’s blood is drawn into the Celacade single-use disposable cartridge and exposed to controlled oxidative stress. The treated blood is then administered to the same patient intramuscularly. An initial course of treatment comprising three consecutive outpatient procedures is administered over a two-week period, and treatments are continued once per month thereafter.
Vasogen makes therapies designed to target the destructive inflammatory process associated with the development and progression of cardiovascular and neurodegenerative disorders.