3 results
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…
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 obtain further data on the safety and performance of the Stellarex Balloon in the treatment of lesions in *below the knee* popliteal (P3 segment) and infra-popliteal arteries according to the Instructions for Use in…