Coronary bypass without suturing: the SAFE-CAB project

 

Coronary Artery Bypass Grafting (CABG) is used to treat severe coronary artery disease, and prevents myocardial infarction (heart attack). Performed on an arrested (non-beating) heart and via a large incision, this procedure is highly invasive. The ELANA Heart Bypass system enables minimally invasive CABG via a laser-assisted procedure on the beating heart without opening the chest. This directly impels shorter recovery and less complications for the patients. The EU-funded SAFE-CAB project plans to accelerate the time to market of this product through final clinical validation and regulatory certification. Their goal is to replace invasive CABG with the ELANA Heart Bypass®, as the new standard of care. Minimally invasive CABG could significantly reduce recovery times, complications, and hospital costs. Being the new standard of care, the ELANA Heart Bypass® could dramatically improve patient outcomes.

Cardiac BioSimulator adding value to the project

Clinical validation and training

The Cardiac BioSimulator platform was recognized for its great potential for preclinical validation and training of clinical teams in the bypass procedure. As such, LifeTec Group was invited to join in this exciting project to give a boost to the development of the clinical procedure as well as the training programme on the ELANA technique. The unique setting that the Cardiac BioSimulator provides is very close to reality, and therefore it represents an important added value to the consortium aiming to bring this new technique to the patients as early as possible. The use of the Cardiac BioSimulator ensures that some of the development and most of the training do not involve live animals, while providing some high-quality hands on experience of the interventional cardiac teams before starting their first human bypass procedures.

  • The AMT bypass clip
    The AMT bypass clip
    The AMT bypass clip
  • Sjoerd van Tuijl providing a workshop on the Cardiac BioSimulator
    Sjoerd van Tuijl providing a workshop on the Cardiac BioSimulator
    Sjoerd van Tuijl providing a workshop on the Cardiac BioSimulator
  • Anastomosis successfully made using Heart Bypass® clip
    Anastomosis successfully made using Heart Bypass® clip
    Anastomosis successfully made using Heart Bypass® clip
  • Flow and pressure assessment of bypass on Cardiac BioSimulator
    Flow and pressure assessment of bypass on Cardiac BioSimulator
    Flow and pressure assessment of bypass on Cardiac BioSimulator
CFD simulations of the coronary bypass
Improve knowlegde

Adding Computer Simulations

To create even more in-depth knowlegde to the bypass procedure, LifeTec Group and AMT Medical added computer simulation modeling to the project. LifeTec Group partnered with the CardioVascular Biomechanics group at the Eindhoven University of Technology to set up Computational Fluid Dynamics simulations of the coronary bypass procedure to improve the knowlegde on blood flow and pressure losses in the coronary system. This allows the team to explore a wide range of scenarios of clinically relevant settings, that can help to create better insights and detailed understanding of specific cases, and potentially improve the outcome of the bypass intervention. At this moment in time, Hanneke Crielaard and Davy Wanders are conducting physical experiments, teaming up with Marieke Hoogewerf at AMT Medical, to apply the ELANA Heart Bypass® technique on the Cardiac BioSimulator platform. These experiments provide data for the computer simulations that allow us to validate the numerical model, and build confidence in the future application of these computer simulation methods.

Head of MedTech Innovation

Marco Stijnen

Senior Research Engineer

Sjoerd van Tuijl

R&D Engineer

Bart Smeets

R&D engineer

Dave Wanders

R&D Engineer

Bertus van de Wetering

Partner Relations Manager

Sheila Owen

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Partner Relations Manager
Sheila Owen
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