3 results
Approved WMOCompleted
The overall objective of this study is to evaluate the efficacy and safety of neoGAA in treatment-naïve patients with LOPD as compared to alglucosidase alfa, when this is administered biweekly for a period of 49 weeks. Also, there is an open-label…
Approved WMOCompleted
The documentation of safety and performance of silicone oil as temporary tamponade in retinal surgery.
Approved WMOWill not start
The purpose of this study is to demonstrate the safety and performance of the Leaflex* when used for aortic valve repair in patients with symptomatic severe aortic stenosis. The main performance objective is to demonstrate an acute increase in…