Table 1:
Summary of In Vivo Trial Outcomes
| Device Design |
Trial No. |
Duration [days] |
Termination Summary | Significant Observations |
|---|---|---|---|---|
| 1 | 1.1 | 30 | Study Completion | Thrombosis at lower and upper bearing |
| 1 | 1.2 | 28 | Study Completion | Thrombosis at lower and upper bearing, significant hemolysis |
| 1 | 1.3 | 8 | Fractured Cannula | - |
| 1 | 1.4 | 27 | Motor Failure | Thrombosis at lower and upper bearing, significant hemolysis |
| 2 | 2.1 | 2 | Animal Welfare | Uncontrollable bleeding at arterial line |
| 2 | 2.2a | 30 | Study Completion | - |
| 2 | 2.3a | 23 | Decreasing Bundle Permeability | Thrombosis at lower and upper bearing |
| 2 | 2.4 | 30 | Study Completion | - |
| 2 | 2.5a | 30 | Study Completion | Thrombosis at upper bearing |
| 2 | 2.6 | 30 | Study Completion | Thrombosis at lower and upper bearing |
| 2 | 2.7a | 3 | Fractured Cannula | - |
| 3 | 3.1a | 30 | Study Completion | - |
| 3 | 3.2 | 4 | Animal Welfare | Internal bleeding |
| 3 | 3.3 | 30 | Study Completion | - |
| 3 | 3.4a | 10 | Increasing Motor Torque | Suspected perioperative thrombus ingestion |
| 3 | 3.5 | 22 | Decreasing Bundle Permeability | Thrombosis at lower bearing |
| 3 | 3.6 | 30 | Study Completion | - |
| 3 | 3.7 | 28 | Study Completion | Thrombosis at upper bearing |
| 3 | 3.8a | 14 | Animal Welfare | Uncontrollable bleeding at cannulation site |
a
These trials required a single device exchange within the immediate postoperative period. These exchanges are discussed further within the Discussion section.