Tetrahedral mesh model of the heart (below) and the evolution of electrical activity for the baseline case with no drug (centre) and after the application of Quinidine (bottom). The electrical propagation turns chaotic after the drug is applied, showing the high risk of Quinidine to produce arrythmias
LivingHeart is available through the Dassault Systemes 3DEXPERIENCE platformon the cloud, offering the speed and flexibility of high-performance computing to the smallestmedical device companies. Any life sciences company can immediately access a complete, environment on-demand to scale up virtual testing securely and collaboratively. “Modelling and simulation play a critical role in organising
diverse data sets and exploring alternate study designs. This enables safe and effective new therapeutics to advancemore efficiently through the different stages of clinical trials,” says Bernard Charlès, CEO of Dassault Systèmes. Vast amounts of public and privatemoney is spent on Cardio-
Vascular Disease (CVD) research and never translated into clinical reality. At the core of this challenge is the difficulty in exploring new and innovative treatment options cost-effectively whilemeeting regulatory requirements for safety and efficacy. In silico techniques hold great promise in their ability to yield
unprecedented insight into basic function and, when sufficiently refined and validated, offer a risk-free environment for predicting in vivo results thatmay be unobtainable any other way. Determining the appropriate clinical treatment for CVD can be greatly enhanced when combined with the insight and guidance revealed through accurate simulation of heart function. The LivingHeart Project is uniting leading cardiovascular
repository andmedical device design tools (MDDTs), has stepped up efforts tomore actively encourage the use of simulation. The FDA recognises the value of simulation for device development, for cardiac services and treatments, and for virtual testing that supports the approval of device submissions. Simulation is also understood to help reduce animal testing and clinical trial costs, improve upon bench testing, and provide deeper understanding of in vivo behaviour where traditionalmethods of assessing devices simply aren’t possible. Since signing a five-year agreement with the FDA in 2014,
Dassault Systèmes is aligning with the regulatory agency on the use of simulation andmodelling to accelerate approvals. The
researchers, educators,medical device developers, regulatory agencies and practicing cardiologists around the world on a sharedmission to develop and validate highly accurate and personalised digital human heartmodels. Thesemodels will establish a unified foundation for cardiovascular in silico medicine and serve as a common technology base for education and training,medical device design, testing, clinical diagnosis and regulatory science – creating an effective path for rapidly translating current and future cutting-edge innovations directly into improved patient care. “Medical devices need thousands of tests in the development
stage,” says Joe Formicola, president and chief engineer at product engineering company Caelynx. “With themove of the
December 2017 /// Environmental Engineering /// 11
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