France-based Dassault Systèmes has entered into a five-year collaborative research agreement with the US Food and Drug Administration (FDA) for its Living Heart Project.
The agreement has been signed to develop testing paradigms for the insertion, placement and performance of pacemaker leads and other cardiovascular devices used to treat heart disease.
The project was launched in May this year to drive the creation and use of simulated 3D personalized hearts in the treatment and diagnosis of heart diseases and medical device development.
Dassault noted that it moved its first realistic 3D heart simulator into beta test, validated the efficacy of a device and has surpassed 30 contributing member organizations.
Dassault Systèmes life sciences vice-president Jean Colombel said: "Through Dassault Systèmes’ 3DEXPERIENCE platform tailored to address unmet medical needs, as demonstrated here in cardiovascular, we support generation of new healthcare solutions and collaborative practices that will ultimately improve patient outcomes and increase patient accessibility."
The project involved leading cardiologists, medical device companies and academic researchers, who helped in the evaluation of the simulated heart model’s use in testing medical devices, improving clinical diagnosis and guiding pre-surgical planning, said Dassault.
Researchers of the project have collaborated with the Medical Device Innovation Consortium (MDIC) to accelerate the approval process of medical devices.
The project has already been used to validate the efficacy of a valve assist device prior to insertion in a real patient and understand the progression of heart disease, noted Dassault.
MDIC president and CEO Bill Murray said: "Computational modeling and simulation has the potential to revolutionize the medical device and healthcare fields by accelerating innovation and providing comprehensive evidence of long-term safety."
Image: Dassault Systèmes has signed a research agreement with the US FDA for Living Heart Project. Photo: courtesy of Business Wire.