FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FEops’ Structural Heart Intervention Simulator Gains CE Mark

April 3, 2019
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FEops has received the CE Mark for HEARTguide, a system used to plan structural heart intervention procedures.

The device uses advanced computational modeling to provide insight into the interaction between transcatheter structural heart devices and patient-specific anatomy. It includes workflows for transcatheter aortic valve implantation (TAVI) and left atrial appendage occlusion (LAAO) procedures.

The system is used to assess complication risks by simulating multiple treatment scenarios prior to an operation related to device sizing and positioning for TAVI and LAAO procedures.

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