FEops, a simulation technology provider for structural heart interventions, has secured CE Mark approval for its HEARTguide.
As per FEops, HEARTguide is a cloud-based procedure planning environment, offering advanced personalized computational modeling and simulation to provide clinicians and medical device manufacturers with preoperative insights into the interaction between transcatheter structural heart devices and specific patient anatomy.
The present release includes workflows for transcatheter aortic valve implantation (TAVI) and left atrial appendage occlusion (LAAO) procedures.
These insights are claimed to have the power to accelerate research and development of new device-based solutions and help in improving clinical outcomes in real-world hospital settings.
FEops HEARTguide helps in assessing the risk of potential complications by pre-operatively simulating several treatment scenarios in terms of device sizing and positioning, both for TAVI and LAAO.
It is claimed that within the TAVI workflow it is also possible to plan TAVI procedures for patients suffering from bicuspid aortic valve stenosis whose incidence is claimed to be increasing with shift towards treating low-risk patients.
FEops CEO Matthieu De Beule said: “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.”
According to the company, the European launch of FEops HEARTguide is a key next step for its vision to become the game-changer in the way transcatheter structural heart devices are designed and procedures are planned in the future.
In September 2017, the company secured €6m in series B financing round led by Valiance and was joined by existing investors including Capricorn and PMV. The company stated that funding will be used to implement its product roadmap, centered around its HEARTguide and drive commercial adoption in the transcatheter valve therapies market.