Preclinical Thrombosis Model for Vascular Devices

Vascular occlusion is a leading cause of significant clinical events like pulmonary thromboembolism, stroke and deep vein thrombosis (DVT). Devices designed to remove or disrupt clots must be tested in models that reflect real clot environments before they reach patients. A well designed preclinical thrombosis model gives developers the data needed build a successful regulatory journey.

Pharmaron’s medical device testing team developed a large animal clot model that addresses core technical challenges in this space. This case study walks through the approach.

Why Preclinical Clot Models Are Difficult to Get Right

Not all clot models produce clinically relevant results. A clot formed for bench testing may behave differently than one encountered during a thrombectomy procedure. Clot consistency and firmness, deploying the clot at a precise location, clot volume, and the ability to keep the clot in place long enough for meaningful evaluation all impact model quality.

This preclinical thrombosis model is suited for:

• Thrombectomy device efficacy testing
• Catheter performance comparison
• Embolic device evaluation
• Deployment across target vessels

Regulatory Considerations

The FDA requires preclinical performance data for vascular devices prior to clearance or approval. Animal models are essential in demonstrating that a device functions as intended under conditions that mimic clinical use. Pharmaron’s model is designed to generate repeatable results that support this kind of structured evaluation.