Preclinical Evaluation Services for Structural Heart Devices Anatomically Relevant Models • GLP-Compliant Protocols • Global Regulatory Alignment

Industry-Standard Large Animal Models

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)