Endoleak Risk Assessment

Guiding surgeons toward optimal device selection to reduce the chances of complications and enhance patients’ outcomes.

FOR CLINICIANS & MEDTECH TEAMS

Assess type 1A Endoleak risk before EVAR intervention

Explore various endograft diameters, landing zones and choose the optimal configuration for the patient

AI-POWERED TECHNOLOGY

16,000 data points measured around the proximal neck

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Clinical Validation

Validation Study - EnduSim II

Retrospective European multicenter study  - ongoing enrollment: Prof Antoine Millon, University Hospitals of Lyon.

Training dataset: 117 patients (Type 1A endoleaks: 34 (13 early, 21 late), 83 controls.

Validation dataset: 56 patients
Assessment blinded to Endoleak status. 20 type 1A Endoleaks (6 early, 14 late), 36 controls.

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Core capabilities

AI-Powered EVAR Planning

Distance Colour Map

With iView Colour, you can instantly highlight the apposition gaps between the graft and aortic wall thanks to Distance Colour Map.

Benefits
Ease risk assessment.
Visually detect critical apposition.
Facilitate simulation comparison understanding.
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testimonials

The expert perspective

First-hand experience from operating rooms to R&D labs — professionals trust PrediSurge to improve outcomes, enhance safety, and accelerate innovation.

"Having a tool that automate the sizing will improve our accuracy and the way we provide the cure to our patients and probably we will focus more on details that may affect the implant…"

Prof. Lucas Bertoglio
Università degli Studi di Bresci
Italy

"Having the AI tool assisting the operator in the planning gives two great advantages. One is that you limit the bias and the risk of misaligning your fenestration during planning. And the second point is that significantly reduce the time needed for planning."

Prof. Michele Piazza
Università degli Studi di Padova
Italy

"These cases from our clinical practice showed how ERI can help you in your decision-making clinical practice when deciding between different endograft sizes."

Dr. Paula Keschenau
Universitätsklinikum Gießen und Marburg GmbH
Germany

AI-driven sizing is not just about saving time—it is about unlocking a new standard of personalised care.

Dr. Fernando Gallardo
Hospital Quirónsalud Marbella
Spain

“PrediSurge technology will represent a significant breakthrough in planning and visualization for endovascular intervention.”

Pr. S. Haulon
Lannelongue Hospital
Paris, France

“PrediSurge technology will profoundly change the planning approach for mitral valve interventions. It will be used by most cardiac centers on a routine basis before any mitral intervention.”

Pr. D. Messika-Zeitoun
Professor of Cardiology
University of Ottawa Heart Institute

“Since we started to use this technology, we have been very impressed with the precision of fenestration positioning associated with outstanding intra and postoperative results…”

Pr. A. Millon
Lyon University Hospitals
Lyon, France

“We strongly believe that this technique will be the gold standard for aortic stent-graft planning and other endovascular procedures in the very near future, bringing huge benefits to patients”

Pr. A. Assadian
Klinik Ottakring
Vienna, Austria
use cases

Clinical Stories

Insights from clinical and R&D practice, directly from our experts

iSizing

iSizing in action

This case was presented with abdominal pain and local tenderness on palpation, the CT findings were: an abdominal aortic aneurysm that had grown from 4.0 cm to 4.7 cm in just three months.

iSizing

iSizing in action

In this Case of the Month, Prof. Rafaelle Spear takes us through how automated sizing and interactive planning come together inside iSizing on a real abdominal aortic aneurysm case at CHU Grenoble Alpes — from CT to a fully specified endograft configuration.

ERI

ERI in action

This case, presented by Dr. Nilo J. Mosquera from Hospital Santiago de Compostela, Spain, highlights how a hostile proximal neck can be managed using ERI to leverage AI-powered Digital Twin technology, enhancing clinical decision-making and improving patient outcomes.

news & blog

Press highlights & Insights

Independent recognition through clinical research and media coverage and PrediSurge insights

Answers to common questions

Frequently asked questions

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What is aortic digital twin?

From a patient’s pre-operative CT scan, the aortic digital twin is created to faithfully reproduce both the shape and the bio mechanical behavior of the real aorta. This advanced 3D model allows precise simulation of how the patient’s anatomy responds to mechanical forces, providing a reliable virtual counterpart of the vessel.

What is ERI?

ERI stands for Endoleak Risk Index, is an AI-powered index based on the analysis of the intervention simulation, with a specific focus on the proximal apposition between the endograft and the patient-specific aortic digital twin. It assesses preoperatively the risk of Type IA endoleak associated with EVAR.

How is ERI calculated?

Each EVAR simulation automatically analyses the proximal aortic neck using 40 cross-sectional slices. For each slice, the aortic wall and endograft are sampled at 200 points each to measure local radii and apposition. This generates up to 16,000 detailed measurements per patient.

Are thrombus and calcifications taken into account?

It is important to distinguish between two different stages of analysis:

  • Simulation: Only the aortic lumen is modeled; thrombus and calcifications are not yet included.
  • Risk assessment (ERI): Thrombus burden is included as a variable in the machine-learning model used to compute risk.

How do we simulate EVAR implantation?

  • Step 1: Creation of Digital Twin of Aorta
  • Step 2: Digital Replica of Endograft
  • Step 3: Simulating the implantation of Endograft

For detailed information: click here

How is EVAR simulation validated?

To validate the accuracy of EVAR simulations, retrospective studies were performed on patients who had previously undergone EVAR. For each case, the pre-operative CT scan was used to generate a patient-specific digital twin of the aorta. The procedure was then simulated virtually using the same Endurant endograft reference and identical landing zones as those employed during the actual intervention.

Clinical Evidence of ERI

To validate the ERI in a clinical setting, a multi-centric retrospective study — EnduSim— was conducted across several European centers. Consecutive patients who underwent EVAR with Medtronic Endurant II devices were analysed and subsequently divided into two groups:

  • Patients with type Ia Endoleak (EL1A)
  • Control patients

For more detailed information,