One of our clients recently conducted a human anatomic study to evaluate the deployment of percutaneous aortic valves. The study utilized whole-body cadaveric specimens and a pressurized flow circuit to provide a representative environment that accurately simulated the aortic vasculature of a patient undergoing trans-aortic valve replacement (TAVR).
Using a heart-lung bypass pump, compatible tubing, and cannulas for inflow and outflow of lactated ringers solution, pressure and flow were established. This enabled the sponsor to measure the aortic annulus in a pressurized state, deploy the percutaneous aortic valve, and evaluate the valve and anatomy for accuracy of placement. The pressurized flow model allowed for injection and clearing of contrast from the cardiac anatomy which therefore simulated the imaging a physician would experience during routine percutaneous valve placement.
The use of a human anatomic model in conjunction with a pressurized flow loop provide a representative environment for percutaneous trans-aortic valves and should be recommended to clients looking to evaluate such medical devices. This model can be used beyond TAVR and should be considered for clients that manufacture vascular devices that require deployment under flow conditions.