DEEPVESSEL®  FFR

Non-Invasive Coronary Artery Functional Assessment

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*CE Marked, NMPA Approved. Not for sale in the United States.
DeepVessel FFR software displayed on desktop

Enabling Better Diagnosis & Treatment of Patients with Coronary Artery Disease

DeepVessel FFR is a software medical device that uses deep learning technology to perform a non-invasive physiological functional assessment of the coronary arteries using coronary computed tomography angiography (CTA) scans. The software processes coronary CTA images semi-automatically, generates a three-dimensional model of the coronary artery tree and computes non-invasive DVFFR values. A PDF report of the derived information is sent electronically to physicians. DeepVessel FFR is intended to support the functional evaluation of coronary artery disease.

DeepVessel FFR applies DeepVessel and DeepFFR techniques, Keya Medical’s proprietary deep learning technologies built on the latest advances in computer vision and medical image analysis. This new approach gives a strong performance advantage with fast processing speed and accurate non-invasive FFR analysis.

How it Works

Clinician sends coronary CTA DICOM images to Keya Medical

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Deep learning algorithms and Keya Medical trained analysts perform the DeepVessel FFR analysis

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An interactive report and 3D model of the coronary arteries is sent electronically to the clinician for review

Product Features

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Non-invasive functional assessment from CTA scan

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Enables accurate and fast FFR analysis

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Provides both anatomical and functional information

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Novel coronary CT FFR technique driven by AI

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Reduces medical cost

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CE marked

Advantages

Non-Invasive

Calculates non-invasive DVFFR values from coronary CTA images to reduce unnecessary coronary catheterizations

Accurate

Achieves 90% diagnostic accuracy using invasive FFR as the ground truth

Comprehensive

Provides both anatomical and functional information to improve clinical decision making

Fast

Delivers results to clinicians quickly for timely decision making

Accessible

Results can be viewed on mobile, PC, and tablet devices

Clinical Performance Assessment

Keya Medical conducted prospective[1] and retrospective multicenter, self-controlled studies in 2017 and 2019. In these trials, FFR measured invasively using a pressure wire was used as the gold standard to evaluate the sensitivity and specificity of DeepVessel FFR in evaluating functional myocardial ischemia in patients with stable coronary artery disease.

2017 Clinical Trial

In 2017, DeepVessel FFR was tested via a multi-center prospective clinical trial in which patients were recruited from:

  • Beijing Anzhen Hospital affiliated to Capital Medical University
  • Air Force General Hospital PLA
  • Cangzhou Central Hospital
Study results demonstrated:
Accuracy 89.2%
Sensitivity 94.2%
Specificity 84.3%
Positive Predictive Value 86.9%
Negative Predictive Value 92.2%

2019 Clinical Trial

In 2019, DeepVessel FFR was tested via a multi-center retrospective clinical trial in which patients were recruited from:

  • Beijing Anzhen Hospital affiliated with Capital Medical University
  • Fuwai Hospital, Chinese Academy of Medical Sciences
  • Beijing Friendship Hospital
  • The First Affiliated Hospital of Wenzhou Medical University
  • The Second Affiliated Hospital of Zhejiang University Medical College
  • Wuhan Asia Heart Hospital
Study results demonstrated:
Accuracy 90.8%
Sensitivity 94.7%
Specificity 88.6%
Positive Predictive Value 83.0%
Negative Predictive Value 96.7%

[1] Wang ZQ, Zhou YJ, Zhao YX, et al. Diagnostic accuracy of a deep learning approach to calculate FFR from coronary CT angiography. J Geriatr Cardiol 2019;16:42-48.

Collaborate with us

We are actively recruiting clinical collaborators in the United States and European Union. To learn more about potential collaboration opportunities, please contact us.