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Ideally, as TAVI becomes standard of care even in low and intermediate risk patients, it would be great to take the guess-work out – to be able to simulate what is going to happen when you put the valve into that anatomy.

Dr Azeem Latib

San Rafaele, Milano, IT

Bringing added value to the entire structural heart product lifecycle 

FEops’ simulation technology uses predictive modeling and simulation to bring rich insights to the development and implantation of transcatheter structural heart devices. It helps accelerate R&D processes and improve patient selection in clinical trials, enables more efficient product approval and launch and helps achieve better clinical outcomes – benefiting device manufacturers, physicians and patients.

To give physicians access to the FEops simulation technology, FEops is currently developing FEops HEARTguide™, a predictive modeling and simulation platform for the planning of transcatheter structural heart interventions. Within the FEops HEARTguide family, the TAVIguide™ workflow is our first CE-marked product. A CE mark for FEops HEARTguide™ with indication for use in TAVI and LAAo is expected in the first half of 2019.

Discover the FEops portfolio

Create better implants faster

The FEops simulation technology suite gives device manufacturers tremendous power to accelerate the development of novel minimally invasive structural heart implants. Introduce virtual patients or digital twins into your workflows before making physical prototypes to gain time, cut costs, and test in clinically relevant contexts.

The FDA wants to advance the use of computational modeling and simulation for medical devices and supports the development of virtual physiological patients, clinical trial simulations and personalized medicine.”

Tina M. Morrison, Office of Science and Engineering Laboratories, Center for Devices and Radiology Health, US Food and Drug Administration (FDA)

Contribute to faster clinical trials

By improving patient selection and optimally preparing physicians for procedures through detailed predictive simulations, FEops’ simulation technology can accelerate your clinical trials and potentially contributes to better patient outcomes.

Optimize the approval process

Medical literature highlights the growing use of computational modeling and simulation (CM&S) to accelerate medtech innovation and regulatory decision-making. FEops’ simulation technology provides data-supported evidence for the safety and efficacy of your structural heart device during the evaluation and approval process.

“We created the Computer Modeling and Simulation Project to achieve the delivery of medical product solutions in a responsible, patient-sparing way that balances the desire for certainty in device performance while limiting delay in patient access associated with increased certainty through the use of computer modeling and simulation as valid scientific evidence.”

MDIC* working group on computational modeling & simulation

*MDIC (Medical Device Innovation Consortium) is the first-ever public-private partnership created with the sole objective of advancing medical device regulatory science for patient benefit. MDIC brings representatives of the FDA, NIH, industry, non-profits and patient organizations together to improve processes for the development, assessment and review of new medical technologies.

Launch your product faster

Make it intuitive for physicians to adopt and endorse your novel structural heart device with FEops’ simulation technology. Inspire confidence and accelerate the learning curve by providing physicians with predictive 3D images that demonstrate how the device will interact with the unique anatomy of each patient – without putting patients at risk.

Bring patients better structural heart outcomes

In going beyond anatomical measurement, only FEops HEARTguide™ provides detailed preoperative insights into the interaction between the implant and the patient’s anatomy. This helps physicians determine optimal implant size and positioning.