Lotus Aortic Valve System study shows benefits
Results from the REPRISE II clinical trial evaluating the safety and performance of the Lotus Aortic Valve System, from Boston Scientific, in patients with severe Aortic Valve Disease demonstrated excellent results with no new valve-related adverse events between 30 days and six months. Additionally, there were no cases of moderate or severe paravalvular regurgitation in any patient at six months.
Excellent hemodynamic results were observed at six months, and independent core lab assessment of paravalvular aortic regurgitation showed 76.1 percent of patients presenting with no paravalvular regurgitation and no cases of moderate or severe regurgitation. There were no new valve-related adverse events recorded between 30 days and six months and the NYHA classification data demonstrated a significant improvement in heart failure symptoms at six months compared to baseline. The data were presented at PCR London Valves.