Pre-clinical Studies
The Crea Aortic Valve System (CAVS) was tested rigorously in both in-vitro and in-vivo models to ensure safety and efficacy
Necessary design and development studies including hemodynamic and fatigue tests over 200 million cycles are completed
Delivery system trackability, function, and deployment of valve testing has been successfully completed
Animal Studies
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- Multiple acute studies were performed during design and development
- Multiple chronic animal studies were performed successfully for greater than 140 days