2 results
Approved WMOCompleted
The primary objective of this study is to examine the effectiveness of the use of a load-reducing orthosis for two months on functioning (using a validated osteoarthritis function questionnaire (WOMAC)) in ten patients with osteoarthritis of 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…