FEops has secured the US Food and Drug Administration (FDA) 510(k) approval for its cloud-based procedure planning solution HEARTguide.
The approval has been given for HEARTguide pre-operative planning of left atrial appendage occlusion (LAAo) with the Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman FLX device.
Utilising digital twin technology, FEops HEARTguide is a first-of-its-kind cloud-based clinical procedure planning tool in the structural heart arena, the company said.
The new solution enables physicians to virtually model clinical scenarios with different implant positions and sizes of these FDA cleared LAA devices, in order to select the suitable size and position for a patient.
St. Bernard’s Heart & Vascular Center, Jonesboro, Arkansas, US, electrophysiology division director Dr Devi Nair said: “FEops HEARTguide is the new generation preoperative planning allowing operators to enter the procedure room with increased confidence for sizing and position for LAAo interventions.”
“The platform is easy to use, very intuitive and provides critical data on how the device will interact with the LAA anatomy.
“The software provides implanting physicians high-quality images that enhance pre-procedure planning for proper sizing of the LAAo device and implant depth.
“It gives the operator the best chance to choose and implant the correct device with confidence and get it right the first time.”
FEops HEARTguide is designed to allow clinicians and medical device manufacturers gain insights into the interaction between transcatheter structural heart devices and specific patient anatomy – preoperatively.
In October last year, FEops received the US FDA De Novo authorisation for its HEARTguide tool.
Headquartered in Gent, Belgium, FEops is a digital health company engaged in streamlining structural heart disease management.
In December 2019, the company received a €3.2m from the European Innovation Council (EIC) accelerator programme.
