FEops HEARTguide Heart Procedure Planning Software Gains CE Mark

FEops, a developer of personalized predictive planning for structural heart interventions, today announced that FEops HEARTguide has received CE mark approval. FEops HEARTguide is a one-in-its-kind procedure planning environment for structural heart interventions that provides physicians unique insights to evaluate device sizing and positioning pre-operatively using novel computational modeling and simulation technology. The current release includes workflows for transcatheter aortic valve implantation (TAVI) and left atrial appendage occlusion (LAAO) procedures.
 
FEops HEARTguide helps to assess the risk of potential complications by pre-operatively simulating multiple treatment scenarios in terms of device sizing and positioning, both for TAVI and LAAO. Within the TAVI workflow, it’s also possible to plan TAVI procedures for patients suffering from bicuspid aortic valve stenosis which incidence is increasing with the shift towards treating low-risk patients.
 
Feedback from some of the pioneers that have been evaluating FEops HEARTguide is very encouraging. Dr. Cameron Dowling (St George’s Hospital, London, UK) stated “FEops HEARTguide gives our team increased confidence to perform TAVI in the most challenging of aortic valve anatomies”. In addition, Dr. Ole De Backer (Rigshospitalet, Copenhagen, Denmark) echoed “I have the strong hope and believe that preprocedural planning with FEops HEARTguide will transform percutaneous LAA closure into an even safer and more efficient procedure for patients with non-valvular atrial fibrillation and contraindications for oral anticoagulant therapy.”
 
“I am extremely proud of the whole FEops team for reaching this important regulatory and commercial milestone and very pleased that we can offer our unique pre-operative planning support to the European clinical community,” said Matthieu De Beule, CEO FEops. The European launch of FEops HEARTguide is a crucial next step to embody FEops’ vision to become the game-changer in the way transcatheter structural heart devices are designed and procedures are planned in the future.
 
FEops HEARTguide cloud-based procedure planning environment uses advanced personalized computational modeling and simulation to provide clinicians and medical device manufacturers with first-ever insights into the interaction between transcatheter structural heart devices and specific patient anatomy—preoperatively. The current release includes TAVI and LAAO workflows. Such insights have the power to accelerate research and development of novel device-based solutions, as well as ultimately help to improve clinical outcomes in real-world hospital settings.