FEops Heartguide Platform Receives CE Mark Approval for Planning Structural Heart Interventions

April 1, 2019—FEops announced CE Mark approval for the Heartguide procedural planning environment for structural heart interventions. The technology provides physicians with insights to evaluate device sizing and positioning preoperatively using novel computational modeling and simulation technology. The current release includes workflows for transcatheter aortic valve replacement (TAVR) and left atrial appendage occlusion (LAAO) procedures.

According to the company, the Heartguide helps to assess the risk of potential complications by preoperatively simulating multiple treatment scenarios in terms of device sizing and positioning, both for TAVR and LAAO. Within the TAVR workflow, it is also possible to plan TAVR procedures for patients with bicuspid aortic valve stenosis, which is increasing in incidence with a shift toward treating low-risk patients.

FEops, which is based in Gent, Belgium, stated that the Heartguide cloud-based procedural planning environment uses advanced personalized computational modeling and simulation to preoperatively provide clinicians and medical device manufacturers with insights into the interaction between transcatheter structural heart devices and specific patient anatomy.

In the company's announcement, Cameron Dowling, MD, of St George’s Hospital in London, United Kingdom, commented, “FEops Heartguide gives our team increased confidence to perform TAVR in the most challenging of aortic valve anatomies.”

Ole De Backer, MD, of Rigshospitalet in Copenhagen, Denmark, added, “I have the strong hope, and believe that preprocedural planning with FEops Heartguide will transform percutaneous LAA closure into an even more safe and more efficient procedure for patients with nonvalvular atrial fibrillation and contraindications for oral anticoagulant therapy.”