CE mark for new TAVI simulation software


FEops has received the CE mark for its transcatheter aortic valve implantation (TAVI) simulation software. The TAVIguide technology is designed to revolutionise preoperative planning for TAVI by providing insights into the interaction between a patient’s native aortic root and the aortic valve. The company reports that clinical evidence shows that implementation of the software enables optimisation of the treatment planning by carefully evaluating the impact of device size and position prior to the intervention, in a patient-specific manner.

A press release reports that the tool will become available early 2016 for individual patients in routine clinical practice in Europe and that it is expected to not only facilitate TAVI treatment planning for the clinician, but most importantly will aid in reducing the occurrence of life-threatening complications, such as paravalvular leakage and conduction abnormalities.

Peter de Jaegere (Erasmus Medical Center, Rotterdam, The Netherlands) says that the new technology will “have important clinical implications”. He adds: “It will allow the selection of both the position and size of the valve for a particular patient (tailored medicine), which will increase the safety and efficacy of TAVI.”

FEops is a Ghent University spin-off that was founded in 2009. According to the press release, the company has developed novel simulation technology that “provides unique insights” to cardiovascular device manufacturers and physicians. The most advanced application is a cloud-based preoperative planning service – the TAVIguide technology. FEops hopes, after further development, to offer advanced preoperative planning tools for other cardiovascular devices such as transcatheter mitral valve therapies