Sam Brusco, Associate Editor02.27.23
FEops released the publication of its PREDICT-LAA study in the journal JACC: Cardiovascular Interventions, showing left atrial appendage closure (LAAC) surgeries planed using its FEops HEARTguide resulted in “significant improvement of procedural efficiency and outcomes.”
Prof. Dr. Ole De Backer (Copenhagen, Denmark), principal investigator of the study, commented to the press, “PREDICT-LAA is the first prospective trial showing that the accuracy of the selection of the LAAC device size and implant position is significantly better when using FEops HEARTguide as compared to standard CT-sizing.”
PREDICT-LAA enrolled 200 patients that were 1:1 randomized to standard planning vs. cardiac CT-simulation-based planning of LAAC using Abbott’s Amplatzer Amulet LAA occluder.
For the FEops HEARTguide arm, the trial showed:
“We are very proud to add this milestone to the other key accomplishments from 2022,” said Matthieu De Beule, Ph.D., co-founder and CEO of FEops. “In 2022, we obtained FDA clearance for FEops HEARTguide LAAO workflow, we became a global digital health player with more than 6000 patients analyzed in over 300 hospitals in 27 countries and we have now, as the first company ever, randomized controlled clinical trial data evidencing the value of digital twin technology in the cardiovascular space. This is putting us in pole position to commercialize globally and extend our game-changing predictive digital twin offering to other applications with our upcoming Series C round.”
Prof. Dr. Ole De Backer (Copenhagen, Denmark), principal investigator of the study, commented to the press, “PREDICT-LAA is the first prospective trial showing that the accuracy of the selection of the LAAC device size and implant position is significantly better when using FEops HEARTguide as compared to standard CT-sizing.”
PREDICT-LAA enrolled 200 patients that were 1:1 randomized to standard planning vs. cardiac CT-simulation-based planning of LAAC using Abbott’s Amplatzer Amulet LAA occluder.
For the FEops HEARTguide arm, the trial showed:
- 15% reduction of total number of LAAC devices used
- 50% recuction of the number of device repositionings
- 25% reduction in use of radiation and contrast media
- 20% reduction of procedural time
- 100% procedural success without major complications
- 40% more complete LAA occlusion with no LAA patency
- 60% less retraction of the Amplatzer Amulet disc into the LAA
- 80% reduced risk of device-related thrombus
“We are very proud to add this milestone to the other key accomplishments from 2022,” said Matthieu De Beule, Ph.D., co-founder and CEO of FEops. “In 2022, we obtained FDA clearance for FEops HEARTguide LAAO workflow, we became a global digital health player with more than 6000 patients analyzed in over 300 hospitals in 27 countries and we have now, as the first company ever, randomized controlled clinical trial data evidencing the value of digital twin technology in the cardiovascular space. This is putting us in pole position to commercialize globally and extend our game-changing predictive digital twin offering to other applications with our upcoming Series C round.”