Press release

FEops HEARTguide receives FDA clearance for LAAo planning capabilities

4 April 2022

FEops HEARTguide receives FDA clearance for LAAo planning capabilities

GENT, Belgium, April 4 th 2022. FEops today announced that it received authorization from the U.S. Food and Drug Administration (FDA) for FEops HEARTguide™ pre-operative planning of left atrial appendage occlusion (LAAo) with the Abbott’s Amplatzer™ Amulet™ and Boston Scientific’s Watchman FLX™ device*.

FEops HEARTguide is a one-in-its-kind cloud-based procedure planning solution in the structural heart space, based on digital twin technology. With the US introduction for the LAAo workflow, FEops HEARTguide™ will enable US physicians to virtually model clinical scenarios with different implant positions and sizes of these FDA cleared LAA devices, helping the physician to select the optimal size and position for every individual patient.

“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.” Said Dr Devi Nair, Director of the Electrophysiology division at St. Bernard’s Heart & Vascular Center, Jonesboro, Arkansas, USA. “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.”

More info on FEops' website