FEops HeartGuide Receives FDA Clearance for Planning Structural Heart Interventions

July 13, 2023—Belgium-based FEops recently announced the release of the company’s HeartGuide cloud-based procedure planning solution, which includes an artificial intelligence (AI)–based anatomic analysis of multislice CT images for the preoperative planning of structural heart interventions.

The FEops HeartGuide is available in the United States for use in left atrial appendage occlusion (LAAO) with the Amplatzer Amulet device (Abbott) and the Watchman and Watchman FLX devices (Boston Scientific Corporation). In the European Union, United Kingdom, Canada, and Australia, HeartGuide is available for use in transcatheter aortic valve interventions and LAAO procedures.

According to the company, HeartGuide combines digital twin-based predictive simulation with AI-based anatomic measurements to provide clinicians and medical device manufacturers with insights into the interaction between transcatheter structural heart devices and specific patient anatomy preoperatively. These insights can improve clinical outcomes in real-world hospital settings, as well as accelerate research and development of novel device-based solutions, stated FEops.

In addition to anatomic analysis, FEops offers predictive simulations that reveal how transcatheter structural heart devices will interact with a specific patient’s anatomy before the implantation. This helps physicians in selecting the optimal device size and position, improving procedure efficiency and outcome.

The company stated that the new HeartGuide is reinforced by the clinical evidence from PREDICT-LAA, which shows it enables time efficiency and better-informed clinical decision-making for structural heart interventions.

PREDICT-LAA is a prospective, multicenter randomized clinical trial that enrolled 200 patients randomized 1:1 to standard planning versus cardiac CT simulation–based planning of LAAO procedures using the Amplatzer Amulet device.

In February 2023, FEops announced that findings from PREDICT-LAA were published by Professor Ole De Backer, MD, et al, in an article titled, “Impact of Computational Modeling on Transcatheter Left Atrial Appendage Closure Efficiency and Outcomes,” in JACC: Cardiovascular Interventions (2023;16:655-666). Previously, the PREDICT-LAA results were presented during the Late-Breaking Innovation session at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

Most recently, data from PREDICT-LAA were presented at CSI Frankfurt, held June 28 to July 1, 2023, in Frankfurt am Main, Germany.

In the company’s press release, Ian Buysschaert, MD, an interventional cardiologist at AZ Sint-Jan Brugge-Oostende in Bruges, Belgium, commented on the clinical value of AI-based anatomic analysis in the FEops HeartGuide.

“The PRECISE-LAA trial results, presented earlier this week at CSI Frankfurt, confirm the positive impact of FEops’ HeartGuide on the decision process for LAAO interventions in daily clinical practice,” stated Dr. Buysschaert. “The key value of FEops’ HeartGuide remains the simulation options predicting different sizes and positions, but the new DICOM interface will allow physicians to better visualize and edit the anatomic measurements, which is extremely useful for the operators.”