Whitepapers

Companies that make cardiovascular devices face increasing market pressures to get their products approved and available faster. As the FDA is opening the doors to digital evidence, medical device companies are beginning to incorporate engineering computer models and simulation early in the design process, allowing them to bring new treatments to patients faster while also meeting safety standards and satisfying time-to-market deadlines. In this whitepaper, we present information on Ansys, a global leader in engineering simulation software, which collaborated with the FDA, the Medical Device Innovation Consortium (US), the Avicenna Alliance (EU), and key policy makers around the world to help develop the pioneering framework and key standards behind in silico trials, as well as how companies are now using in silico trials to perform testing in virtual patients. Blood Flow Devices – A Quick Summary There are three classes of medical devices—Class I, II, and III—that range from low risk (Class I) to high risk (Class III) of patient health and safety. Blood flow devices are medical devices that improve blood flow or drug delivery within the circulatory/cardiovascular system. Common blood flow devices are: ► Class III: Blood pumps, heart valves, blood filtration devices, and arterial stents ► Class II: Infusion devices and catheters ► Class I: Cholinesterase test paper, drug specific control materials, and finger cots Two of the primary design challenges associated with blood flow devices are: 1. Minimizing blood flow wall shear stresses to mitigate thrombosis, or blood clotting, and hemolysis, the destruction of red blood cells, while still maintaining sufficient wall shear stress to minimize the potential for flow stagnation on blood contacting surfaces of the device. 2. Maximizing the location/distribution of an infused drug for effective and expedient delivery to the targeted organ in the circulatory system Simulating Blood Flow Mechanics with Ansys Software Since 1970, Ansys has been a leader in engineering simulation and 3D design software that delivers product modeling solutions with unmatched scalability and a comprehensive Multiphysics foundation. To develop solutions that address current challenges faced by blood flow device companies, Ansys has been instrumental in developing the framework and key standards behind in silico trials, or individualized computer simulations that create virtual human laboratories. In addition to Ansys Fluent, the world-leader in general purpose Computational Fluid Dynamics (CFD), Ansys also offers best-in-class rotating machinery CFD solutions, such as in a blood pump, through its CFX solver. Today, companies around the world that make blood flow devices leverage these Ansys tools to accurately predict hemodynamics and test potential problem scenarios. By gaining confidence in the performance viability and device safety early in the process, companies can introduce innovative, safe, and effective devices and drug therapy applications faster and at a lower cost by: ► Accelerating the time to animal and human clinical trials ► Shortening the regulatory approval process ► Providing visual substantiation and performance characterization data with FDA submissions: ► 510(k) to show "substantial equivalence" to an existing device for Class II submissions (no clinical trial required) ► Investigational Device Exemption (IDE) and premarket approval (PMA) for Class III submissions (clinical trial required)

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