Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
Medtronic Endovascular
Summary
The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberant™ Thrombectomy System, also known as the Liberant Clinical Assessment, is to collect first-in-human clinical data to confirm the safety and performance of the Medtronic Liberant™ thrombectomy system when used for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems
Description
The Liberant Clinical Assessment is a multicenter, prospective per patient HCP recollection survey. Participating HCPs will document their individual case experience following routine utilization of Liberant in accordance with the approved device labeling. Individual use cases will be entered within 72 hours of device usage to identify periprocedural incidents of risk and evaluate device performance. At least 50 use cases will be collected and aggregated from at least 10 participating HCPs. This data collection is for a single point in time, with no patient follow-up. Individual HCP responses…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Patient case selection to be included in the clinical assessment will be specific to Liberant and will be made according to the following criteria: 1. Patient treated is age ≥ 22 years at the time of procedure 2. Use of Liberant in accordance with the device labeling within 72 hours of index procedure
Interventions
- DeviceLiberant Thrombectomy System
The Liberant thrombectomy system is indicated for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems
Location
- Naples Comprehensive HealthNaples, Florida