FEops HEARTguide

by FEops NV  · Based in Belgium → — Advancing personalized care in structural heart disease through predictive simulations.
Cardiology Cardiothoracic Surgery
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Regulatory Status Disclosed

Overview

FEops HEARTguide, developed by FEops NV (a Materialise company), is a cloud-based structural heart procedure planning platform. The technology combines artificial intelligence and predictive simulation to analyze cardiac computed tomography (CT) scans, providing clinicians with detailed anatomical measurements and insights into how transcatheter structural heart devices will interact with a patient’s unique anatomy.

The platform is designed for multidisciplinary heart teams, including interventional cardiologists, cardiothoracic surgeons, and imaging specialists, operating in hospital and clinical settings. It supports the planning of complex structural heart interventions, specifically Left Atrial Appendage Occlusion (LAAO) and Transcatheter Aortic Valve Implantation (TAVI).

FEops HEARTguide integrates into the clinical workflow via a secure, cloud-based portal featuring a DICOM interface. Clinicians upload patient CT scans to receive AI-enabled anatomical analyses and predictive simulations. Notable capabilities include:

  • AI-Based Anatomical Measurements: Automated, time-efficient measurements of cardiac structures with the option for manual adjustments.
  • Predictive Device-Host Simulations: Virtual modeling of device-anatomy interactions to assist in selecting optimal device sizes and positioning.
  • TAVI Lifetime Management: Tools to evaluate future valve-in-valve procedures and long-term patient care pathways.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Predictive simulation technology
  • AI-based anatomical measurements
  • Digital twin technology for patient-specific replicas
  • Cloud-based platform with anytime, anywhere access
  • DICOM interface for CT scan upload
  • Semi-automatic identification and measurement of anatomical landmarks
  • Interactive 2D and 3D viewer
  • Evaluation of device sizing and positioning pre-operatively
  • Secure case sharing with peers and industry partners
  • Multi-factor authentication and enforced password changes for security

Use Cases

  • Pre-operative planning for Left Atrial Appendage Occlusion (LAAO) procedures
  • Pre-operative planning for Transcatheter Aortic Valve Implantation (TAVI) procedures
  • Optimizing device sizing and positioning for structural heart interventions
  • Predicting device-anatomy interaction to reduce complications
  • Improving procedural efficiency and outcomes in structural heart disease
  • Accelerating research and development of novel cardiovascular devices

What Physicians Need to Know

Cardiac CT/MRI Analysis
FEops HEARTguideu2122 analyzes cardiac computed tomography (CT) scans to create patient-specific digital twins of the heart or its substructures. It uses AI-enabled anatomical analysis for precise measurements and detailed assessment of structures like the left atrial appendage (LAA) morphology. The platform provides visualization and image reconstruction techniques, including 2D review and Multiplanar Reconstruction (MPR). Future developments aim to fuse these simulations with live fluoroscopic images during procedures for enhanced precision.
Coronary Artery Assessment
For TAVI lifetime management, FEops HEARTguideu2122 provides insights into coronary access for future redo-TAVI options.
AHA/ACC Guideline Alignment
FEops HEARTguideu2122 is a CE-marked platform available in various markets including the EU, UK, Switzerland, Canada, Australia, and the US (with specific clearances for workflows like LAAO). It is designed to optimize treatment planning and improve patient outcomes in structural heart disease, aligning with the goal of advancing good health and well-being.
Real-Time Alert Capability
While not providing 'real-time alerts' for continuous patient monitoring, FEops HEARTguideu2122 offers predictive simulations and data-driven insights pre-procedure to help physicians make informed decisions, reduce complications, and improve procedural efficiency and outcomes for interventions like TAVI and LAAO. The platform's pipeline includes enhancing AI algorithms for faster, more consistent, and accurate anatomical analyses, and the ability to fuse simulations with live fluoroscopic images inside the cath lab for unmatched precision during procedures.
Physician Tip

FEops HEARTguideu2122 is invaluable for pre-procedural planning of complex structural heart interventions such as TAVI and LAAO. Leverage its digital twin and AI-enabled simulation capabilities to virtually test different device sizes and positions, predict device-anatomy interaction, and anticipate potential complications like paravalvular leak or conduction abnormalities. This can lead to more informed decision-making, reduced procedural complications, and improved patient outcomes. The platform's collaborative features also enable secure case sharing with peers and industry partners for enhanced discussion and learning.

FEops HEARTguideu2122 is a cloud-based platform, offering secure access from anywhere at any time. It features a DICOM interface for easy upload and review of patient CT scans. The platform has partnered with companies like TeraRecon for commercialization and integration of its LAA occlusion workflow into existing software solutions, streamlining pre-treatment CT-based planning for structural heart interventions.

Details

Category Cardiology AI, Surgical AI
Pricing Contact for pricing
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

FEops HEARTguide™ received De Novo authorization (DEN200030) from the U.S. FDA in October 2021 for pre-operative planning of left atrial appendage occlusion (LAAO) with the Boston Scientific WATCHMAN™ device. Subsequently, it received 510(k) clearance in April 2022 for LAAO planning with Abbott's Amplatzer™ Amulet™ and Boston Scientific's Watchman FLX™ devices. In June 2023, FEops received FDA clearance for its AI-based anatomical analysis capabilities. Note that TAVI simulations are not yet available for clinical use in the US, pending 510(k) clearance.
Integrations
EHR Not specified
Specialties Cardiology, Cardiothoracic Surgery

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Press & Coverage

FEops Press Release
FEops joins forces with Materialise
FEops announced in July 2024 that it is joining forces with Materialise, aiming to expand cardiovascular care through AI-driven simulation and integrate with Materialise's 3D planning insights.
2024-07
FEops Press Release
Clinical utility of FEops AI-enabled predictive pre-planning for LAAO demonstrated in US
Data presented at the AF Symposium 2024 in Boston demonstrated the clinical utility of FEops' AI-enabled predictive pre-planning for Left Atrial Appendage Occlusion (LAAO) procedures in the US, showing improved efficiency.
2024-02
FEops Press Release
FEops Partners with TeraRecon to Scale the Commercialization of FEops HEARTguide, its Digital Twin Solution for an Elevated Structural Heart Experience
FEops partnered with TeraRecon in October 2023 to scale the commercialization of FEops HEARTguide, integrating its LAA occlusion workflow into TeraRecon's software, particularly for the US market.
2023-10
FEops Press Release
FEops Receives FDA Clearance for Its AI-Based Anatomical Analysis Capabilities
FEops announced in June 2023 that it received FDA clearance for its AI-based anatomical analysis capabilities within FEops HEARTguide, streamlining pre-operative planning for structural heart interventions.
2023-06
Business Wire
FEops HEARTguide Proven to Significantly Enhance Efficiency and Outcomes of LAA Closure Procedures
A February 2023 publication in JACC: Cardiovascular Interventions detailed the PREDICT-LAA study, showing that FEops HEARTguide significantly improved procedural efficiency and outcomes for Left Atrial Appendage Closure (LAAC) procedures.
2023-02
JACC Advances
FEops HEARTguide Patient-Specific Computational Simulations for WATCHMAN FLX Left Atrial Appendage Closure: A Retrospective Study
This November 2022 study demonstrated that the FEops HEARTguide model accurately predicts WATCHMAN FLX device implantation characteristics, with blind simulations predicting the final implanted device size in 72.7% of patients.
2022-11
Business Wire
FEops' AI-enabled Solution Changes TAVI Pre-procedural Decision in One Third of Patients, Associated With Favorable Clinical Outcomes
Data from the PRECISE-TAVI study, presented at PCR Valves 2022, indicated that FEops HEARTguideu2122 changed pre-procedural decisions in 35% of TAVI patients with complex aortic anatomy, leading to favorable clinical outcomes.
2022-11
FEops Press Release
FEops HEARTguide receives FDA clearance for LAAo planning capabilities with Amulet and Watchman FLX
FEops announced in April 2022 that it received FDA authorization for FEops HEARTguideu2122 for pre-operative planning of left atrial appendage occlusion (LAAo) with Abbott's Amplatzeru2122 Amuletu2122 and Boston Scientific's Watchman FLXu2122 devices.
2022-04

Videos

Product demos, reviews, and walkthroughs for FEops HEARTguide.

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Frequently Asked Questions

FEops HEARTguide combines predictive simulation with AI-based anatomical analysis of MSCT images to aid in pre-operative planning for structural heart interventions like Transcatheter Aortic Valve Implantation (TAVI) and Left Atrial Appendage Occlusion (LAAO). It helps physicians select optimal device size and position by simulating device-anatomy interaction, aiming to improve procedural efficiency and outcomes.
FEops HEARTguide has received FDA clearance for AI-based anatomical analysis in TAVI and LAAO, and for LAAO planning with specific devices in the US. It also holds CE Mark approval in Europe, UK, Canada, and Australia for TAVI and LAAO workflows. Data confidentiality is ensured in line with national privacy legislation such as GDPR and HIPAA, and it is a prescription-use-only device.
Limitations include that it is not intended to replace device instructions for use or serve as a stand-alone diagnostic tool. Some studies have noted small sample sizes and limited generalizability of findings to all LAAO devices. Additionally, the accuracy of patient-specific computer simulations for predicting certain complications, like paravalvular leakage or conduction disturbances, is continuously being refined.
Traditional pre-procedural planning often relies on basic anatomical measurements and manual 'rigid-device overlay' techniques. Other software solutions exist, such as Mimics Enlight LAAO, WATCHMAN TruPlan, and 3mensio Structural Heart, which offer various planning and sizing tools for structural heart interventions.
FEops HEARTguide is a cloud-based platform where physicians upload patient CT scans for analysis, and results are returned to a secure portal for review. The system offers semi-automatic identification and measurement of anatomical landmarks, but importantly, physicians retain full control with options for manual measurements and editing.
FEops HEARTguide operates on a service-based business model where clinicians provide input data and FEops delivers the analytical results. While clinical studies have shown improved procedural efficiency and outcomes, the cost-effectiveness of FEops HEARTguide remains uncertain. The use of FEops may incur additional costs for a CCT scan compared to standard TEE-based planning.

Compare FEops HEARTguide

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FEops HEARTguide focuses on pre-operative planning for structural heart procedures using predictive simulations and digital twin technology. In contrast, KardiaPro is designed for remote patient monitoring, managing ECG,…
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More from FEops nv

FEops HEARTguideTM
FEops nv
Cardiology AI
FEops HEARTguide™ is a cloud-based AI and digital twin platform for structural heart procedure planning, providing predictive simulations and anatomical insights to optimize device sizing and positioning for interventions like TAVI and LAAO.
Contact for pricing

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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