3 results
The purpose of this Clinical Investigation Plan is to collect data on the safety and performance of the WiCS-LV system. It is designed to satisfy requirements for clinical data and post market clinical follow-up for the Active Implantable Medical…
The objective of this study is to investigate whether reconstruction of the radiocarpal joint by implantation of a tailor-made and patient specific 3D printed interpositional arthroplasty made out of Bionate® II 80A PCU (DSM®) is feasible as a…
5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…