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 primary objective of this second phase study is to estimate the occurrence of anastomotic leakage when the C-seal is used.Secondary objectives are:* Feasibility of applying the C-seal, especially considering the improved attachement to the…