2 results
Approved WMORecruiting
Primary objectiveTo collect data for the continuous development of an algorithm to determine the bladder filling status with the future TENA Bladder Sensor.Secondary objectiveTo document adverse events (AE) and device deficiencies (DD): namely AEs,…
Approved WMORecruiting
See section 3.2 on protocol page 24The purpose of the clinical study is to demonstrate the safety and efficacy of the EV ICD System: a complete single-chamber extravascular ICD system with the lead implanted substernally