WP1 Technical development & validation
FEops HEARTguide is recognized as a very promising platform for pre-operative planning and peri-operative guidance of transcatheter structural heart interventions. We have developed a predictive model for a new indication, Transcather Pulmonary Valve Replacement (TPVR), and for new devices for our existing Transcatheter Aortic Valve Implantation (TAVI), Left Atrial Appendage Occlusion (LAAO) and Transcather Mitral Valve Replacement (TMVR) workflows in addition to extending our predictive models over different ethnic groups.
To turn FEops HEARTguide into a total solution, the LAAo simulation workflow has been extended with a complete anatomical analysis.
And finally, to turn FEops HEARTguide into a scalable pre-operative planning tool, deep learning models for automatic segmentation of the left atrium have been successfully trained.
The results of this work package contribute to the societal goals as device manufacturers are exploiting our technology to design next generation implants, which helps reducing the amount of trials in animals and humans.
WP2 Industrialization
To turn FEops HEARTguide into a scalable pre-operative planning tool, we have embedded new features and predictive models in the FEops HEARTguide platform and have prepared it for mass production. For the existing FEops HEARTguide workflows, we have automated the different steps of the process to shorten turn-around times and have developed Artificial Intelligence models to automate image segmentation & anatomical landmark detection.
With regards to certification, market clearance or approval has been obtained for EU under MDR, US, Australia and Canada.
The results of this work package have been disseminated through press releases, social media and at scientific conferences and helped to attract new talent: FEops has attracted more than 10 people since the beginning of the EIC-supported HEARTguide project and established international and interdisciplinary collaborations.
WP3 Clinical validation
The new features and predictive models have been clinically validated in over 700 patients along several retro- and prospective clinical investigations, in which we have generated evidence on the (i) predictive power and (ii) clinical and economical added value of our pre-operative planning platform FEops HEARTguide.
The principal investigators in charge of our clinical investigations, led the communication to their peers via scientific publications and at international scientific cardiology conferences.
WP4 Market validation
Supported with the evidence from the clinical investigations, we eased market entrance for FEops HEARTguide and created momentum in the market with limited access releases for the physicians and hospitals. More than 2,200 cases have been simulated over several centers worldwide, generating very useful feedback on the FEops’ business model and providing recurring revenue streams.
Although almost all physical meetings (conventions, business meetings transatlantic, …) were cancelled due to Covid-19, we have been able to keep good visibility with our target audience
