The Living Heart Project kicked off in 2014 with the aim of producing the first simulated real-life heart powered by the 3DExperience platform from Dassault Systèmes (Velizy-Villacoublay, France) in a five-year partnership with FDA. The goal, as stated by Dassault, was to “target the development of testing paradigms of the insertion, placement and performance of pacemaker leads and other cardiovascular devices to treat heart disease.” The project has achieved several milestones in the first five years, and Dassault announced today a five-year extension of the collaboration with FDA.
The 3DExperience platform will be used to develop a new digital tool to enable more efficient regulatory review of cardiovascular and medical devices, said Dassault in a press release. Researchers hope the first-of-its-kind process will increase industry innovation and pave a way forward for patients to access safe, effective new treatments for heart disease, the leading cause of death in the world.
Milestones in the first phase of the project include:
- Public release of the first 3D human heart simulator in 2015;
- simulation of blood flow in the beating living heart and extension of the 3DExperience platform to simulate medical treatments in the brain in 2016;
- the Living Heart is uploaded to the cloud in 2017, allowing organizations of all sizes with access to leading edge digital design and testing tools;
- the Living Heart is extended to predict the safety of drugs prone to cause arrhythmias in 2019.
The second phase of the collaboration supports FDA’s 21st Century Cures Act, using virtual patients based on computational modeling and simulation to improve the efficiency of clinical trials for new device designs. A groundbreaking project with the simulated 3D heart model will examine the use of heart simulation as a source of digital evidence for new cardiovascular device approvals. This includes an in silico clinical trial (meaning that the trial is conducted via computer simulation), aiming to reduce animal testing or the number of patients required while producing results that reliably demonstrate device safety and efficacy. The digital process also could be more efficient and less expensive than conventional clinical trials, and possibly accelerate patient access to novel treatments, according to Dassault. The FDA has publicly recognized its potential health benefits.
“Modeling and simulation can help to inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study and assess product safety,” said Tina Morrison, PhD, Deputy Director in the Division of Applied Mechanics, Office of Science and Engineering Labs, Center for Devices and Radiological Health, FDA. “In some cases, in silico clinical trials have already been shown to produce similar results as human clinical trials.”
“Our collaboration with the FDA underscores the relevance and sustainability of digital twin experiences created with the 3DExperience platform to test devices and drugs in scientific and medical innovation,” said Claire Biot, Vice President, Life Sciences Industry, Dassault Systèmes. “Enriching technology already well established in regulated industries such as aerospace and automotive, virtual patients support the complex development of therapies for the heart, brain and more by eliminating traditional cost and time bottlenecks. With this new review process, Dassault Systèmes and the FDA can be partners in the transformative impact of the virtual world on industrial innovation, new treatments and the patient experience.”