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…
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…
Primary Objective There are two co-primary objectives; one regarding each tibial component configuration, fixed bearing (FB) and rotating platform (RP): 1) Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported…