The US Food and Drug Administration (FDA) has expanded its partnership with simulation environments provider Dassault Systèmes for the Living Heart simulated 3D heart model.
Backed by Dassault’s 3DEXPERIENCE platform, the Living Heart project has been designed to enable the safe and effective development of cardiovascular products and treatments through the simulation and creation of personalised digital human heart models.
The FDA initially partnered with the company in 2014 to use the project for the development of testing models to insert, place, and perform cardiovascular devices, including pacemaker leads.
As part of the five-year extension, a new digital tool for regulatory review of cardiovascular and medical devices will be created using the 3DEXPERIENCE platform.
The partners plan to use virtual patients based on computational modelling and simulation in order to improve the efficiency of clinical trials for new devices.
The Living Heart simulated 3D heart model will also be utilised to test heart simulation as digital evidence for approvals of new cardiovascular devices.
An in silico clinical trial will be conducted in a bid to evaluate the feasibility of reducing animal testing or the number of patients, while still validating the device’s safety and efficacy.
FDA Division of Applied Mechanics deputy director Tina Morrison said: “Modelling and simulation can help to inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study, and assess product safety. In some cases, in silico clinical trials have already been shown to produce similar results as human clinical trials.
“The FDA continues to encourage research to facilitate the introduction of safe and effective therapeutic solutions.”
The digital process is expected to be more efficient and less expensive compared to existing approaches, in turn allowing better patients access to new treatments.