Periodic Reporting for period 1 - TAVIguide (ICT platform to reduce mortality rates for Transcatheter Aortic Valve Implantation (TAVI) by pre-operative risk management)
Reporting period: 2016-01-01 to 2016-04-30
FEops is developing future generation procedure planning technology for transcatheter structural heart therapies. Because the transcatheter treatment of structural heart disease is delivered via wires inserted through small access sites (e.g. the femoral artery), there is a consensus that procedure planning is critical (e.g. access, device type/size, implantation position) and the way to further reduce the complications. During the procedure the interventional cardiologist needs to manipulate the delivery system relying on (fused) imaging sources (X-ray, US, MRI). Current procedure planning is based on measurements performed on these 2D or 3D images, though the current complication rates clearly indicate that the current sizing tools and algorithms are not adequate. The overall objective of the project is to update the business plan for developing a unique and proprietary portfolio of novel planning tools, based on advanced patient-based computer modeling. The images of the patient are converted into a computer model that allows to pre-operatively assess the impact of the device/host interaction, aiming to minimize the risk for the patient significantly.
Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far
The H2020 phase 1 SME-instrument entitled FEops to perform an in depth analysis of the structural heart disease market and revise the business plan with updated strategic insights on how to commercialize this disruptive technology. Our market research has clearly shown that besides transcatheter aortic valve implantation (TAVI), other minimally invasive cardiovascular procedures can highly benefit from our simulation-based planning technology and thus our technology backbone allows building a sustainable product portfolio. It has become clear that the development of these simulation-based planning tools in the structural heart space should be the primary focus of FEops, which is the first company in the world to bring this technology to the clinical practice, and will result in a profitable business model. Interesting side effects of the development of this technology is that it also proves to be extremely useful in the research and development of novel transcatheter structural heart technologies.
Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)
A fast growing number of patients undergoing transcatheter cardiovascular procedures could significantly benefit from FEops’ patient-based planning approach and FEops is uniquely positioned to offer all these implant technologies the necessary guide to further improve safety and efficacy.