5 results
To obtain the safety and effectiveness data necessary to support a Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA)
To determine the effect of RIPC of the upper limb on the inflammatory response during human endotoxemia (infusion of LPS), as well as the additional effect of 7-day RIPC compared with single-dose RIPC.
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 study aims to determine the safety and efficacy of the steering module in a clinical setting.
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…