FEops HEARTguideTM, FEops HEARTguideTM ALPACA
FEops nv
Authorized purpose: Enable visualization and measurement of heart and vessel structures for preprocedural planning and sizing of structural-heart interventions, including LAAO and TAVI; qualified clinicians use the results with clinical history, symptoms, other evaluations, and professional judgment, and the results do not replace implant-device instructions for final device selection or placement.
- Modality
- CT/CTA
- Anatomy
- Heart and cardiovascular vessels, including the left atrium, left atrial appendage, aortic root/ascending aorta, and left ventricle
- Decision
- 2023-06-06