FEops announced that its HeartGuide computational modeling and simulation technology has received CE Mark approval.
HeartGuide is a procedure planning technology that is used for structural heart interventions to give physicians unique insights. Doctors can then evaluate device sizing and positioning before operations using computational modeling and simulation technology.
“FEops HeartGuide gives our team increased confidence to perform TAVI in the most challenging of aortic valve anatomies,” Dr. Ole De Backer, one of the first doctors to evaluate the HeartGuide, said in a press release. “I have a 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 non-valvular atrial fibrillation and contraindications for oral anticoagulant therapy.”
The technology simulates treatment scenarios for device sizing and positioning in TAVI and LAAO.
“I am extremely proud of the whole FEops team for reaching this important regulator and commercial milestone and very pleased that we can offer our unique preoperative planning support to the European clinical community,” Matthiew De Beule, CEO of FEops, said.
FEops HeartGuide is cloud-based and also uses advanced personalized computational modeling to give clinicians and medical device manufacturers insight into the interaction between trans catheter structural heart devices and specific patient anatomy.