2 results
Approved WMOCompleted
Primary:Does the implementation of a Parietene® self-fixing semi-resorbable mesh (Covidien-Sofradim) result in less chronic inguinal pain as compared to a standard polypropylene mesh (Marlex®; Bard) in the treatment of a inguinal hernia using the…
Approved WMOCompleted
Primary Study Objectives:Safety objective: assessment of procedure related mortality up to 30 days post-procedure.Performance objective: demonstration of the ability of Valvosoft to modify the structure of the calcified valve leaflets to improve…