| Medical Device | Preferred Species | Disease Model |
|---|---|---|
| Transcatheter Aortic Valves (TAVR) | Ovine (Sheep) | Surgically induced aortic stenosis |
| Mitral Valve Repair Systems | Porcine (Swine) | Chronic ischemic |
| Left Atrial Appendage (LAA) Occluders | Canine (Beagle) | Spontaneously thrombogenic |
| Tricuspid Valve Repair Devices | Canine (Beagle) | Heart Failure |
| Test Category | Methodology | Compliance |
|---|---|---|
| Hemocompatibility | Platelet activation (P-selectin flow cytometry) | ISO 10993-4:2017 |
| Hemodynamic Performance | Pressure-volume loops (PV Loop analysis) | FDA Guidance (2021) |