Introduction

Well, we all know how the COVID pandemic has evolved, and at the end of last year – with the vaccines on the brink of becoming available – we could not have foreseen how the situation developed over the year 2021. Currently, the world is struggling with the Omicron variant, and numbers are still going up and down around the globe. The situation asks for flexibility and capacity to adjust, and in that context we are sharing this news overview to highlight the successes were able to achieve in 2021.

We were very happy to see that we have been able to welcome a few new clients into our labs - either physically or via remote connection - despite all COVID-related restrictions! Similar to 2020, though, we have been working very hard on improvements and added functionality of our already great simulator models. Below we will share some highlights of new research projects and their achievements.

New Developements

(Re-)Active simulation models

In standardized regulatory pulse duplicator testing for heart valve devices, the testing procedure is very well defined where a fixed flow pulse is prescribed to a prosthetic heart valve. This is great to produce comparable data of valve performance, but it is not always predictive of what happens in-vivo. When a clinical intervention is performed, the loading condition of the heart has changed and the heart will respond, and as a result the rest of the body will also respond. Therefore, if you’re interested in predicting how a patient would respond to a treatment, the standardized test methods do not reflect the responses of the body.

At LifeTec Group we have been working on implementing computer algorithms based on literature models, that can mimic contraction of the cardiac muscle – rather than prescribe a fixed flow pulse – and on algorithms that simulate systemic response of the body so that vascular resistance can change with demand from the body.

Once these add-ons are fully functional, the next generation of test platforms will be capable of responding to an intervention similar to what happens in-vivo, which will be especially interesting for heart valve repair or replacement and ventricular assist device studies.

New Developments

Cardiac contraction modeling

We have teamed up with Dutch SME Cardiac Booster in a grant project to develop our cardiac contraction model, where CardiacBooster will develop a novel ventricular assist device. You can read more in this newsitem.

New Developments

Automated Hemodynamics

Within H2020 funded project SAFE-CAB we have been developing the hardware and models that will allow the automated response of the body to changes in heart function. The first step is that we can pre-define what pressure settings we need and the system will automatically regulate system components to achieve those targets. In a later stage these set targets will be resulting from computer algorithms that simulate bodily responses. More background can be read here.

Technology Improvements

Mobile Cardiac BioSimulator for on-site training

Also within the SAFE-CAB project, we are working in collaboration with AMT medical on a clinical training simulation for sutureless bypass surgery. Our interest in this project is to further develop our Cardiac BioSimulator (CBS) platform into a more compact mobile system (with the working title “tinyCBS”) with which on-site training procedures can be simulated to instruct clinicians on this new procedure prior to them performing their first in-human interventions.

If you have a need for on-site testing or demonstrations, and would like to know how our mobile CBS platform could support you then please feel free to contact us.

Read the newsitem here.

Technology Improvements

Soft Tissue Embalming

The competent authorities are asking companies that wish to bring new devices to the market to provide data obtained from testing that is as close as possible to real in-vivo data, so as to minimize the risk to the patients. In this context, the use of human cadaveric material to mimic true patient anatomies and pathologies is increasing. Even though these tissues are anatomically much more relevant, the poor tissue quality is often a limiting factor compared to live animal research – which in turn is also ethically burdensome.

To make an improvement in the use of human cadaver tissues, we have been working on soft embalming techniques with a focus on increasing tissue quality while keeping tissue stiffness realistic. And the early results are very promising; where usually a human cadaver heart cannot withstand physiological ventricular pressures and normal fixation protocols make the tissue very stiff, we have been able to preserve human hearts such that they can bear a pulsatile ventricular load of over 100 mmHg while the tissue is still realistically pliable and the native heart valves are still functioning well.

Read more on our first studies on human cadaveric materials in the newsitem.

Feel free to reach out if you wish to know more about how soft tissue embalming might benefit your project.

Technology Improvements

Importance of Clinical Imaging

This year we also paid attention to clinical imaging in combination with our organ platforms. Surely, in our lab we have fantastic opportunities for ‘engineering’ measurements such as cardiac videoscopy, but in clinical practice that is not available and so to make a good transition from lab to hospital environment, realistic imaging is an important factor.

Read more in our newsitem.

If you are planning to simulate your procedure for future clinical users, but don't yet want to risk engaging with lab animals or you're not yet ready for human trials, we can provide a clinically relevant setting for you to get a valuable clinical feedback.

Technology Improvement

3D Printing

This year we have also installed a 3D printer in our lab! This addition to our facilities has proven to be really helpful in producing new parts quickly, allowing us to adapt to your requirements for device introduction, printing custom fixation or stabilization parts, or making changes to better accommodate compatibility to clinical imaging. Get in touch with us if you want to know more about how we can help you set up a most clinicaly relant test using 3D printing technology!

We truly believe that computer simulations can be very helpful to clients that bring prototypes to our lab for an experimental study. Following these experiments, we have validation data to tune a computer model – which we could then use to simulate the effects that small design changes would have on device performance to direct the design improvements before our clients embark on manufacturing a next version. Below a short summary of our efforts on this front.

Computational Modeling

Simulating Coronary Interventions

Following our previous efforts on 1D simulations of coronary stenting or bypass surgery as reported in our AngioSupport project, and the subsequent comparison to 3D CFD simulations, we have continued this line of R&D focusing on simulating true 3D patient geometries and comparing to their 1D equivalents to learn where geometrical simplifications can be justified and 3D is necessary. These activities are aligning with the SAFE-CAB project and AngioSupport, in close collaboration with the CardioVascular Biomechanics group of prof. van de Vosse at TU/e and the Catharina Hospital.

Read more on the sutureless bypass technique and modeling in our newsitem.

Computational Modeling

Simulating Device-Tissue Interaction

We have joined a European Research Project called UPSIM - which started at the very end of last year - to further back our efforts in numerical simulations. Within the UPSIM project, we are teaming up with a consortium of simulation experts, focusing on creating models and workflows to virtually simulate device-tissue interaction. More info on the healthcare usecase in UPSIM can be found on the project website.

If you're interested in using computational analyses for your project, feel free to get in touch!

BioLiver Platform

This year has brought some new interesting insights on ex vivo liver perfusion in our BioLiver platform. The prototype design has been improved which enables a closed and sterile environment for ex vivo liver perfusion. This led to the first study of porcine slaughterhouse livers showing maintained viability and functionality over 12h of perfusion. Also optimization of the perfusate was continuously improved to ensure good metabolism and perfusion for longer term experiments.

The possibility to compare lab animal obtained livers with slaughterhouse obtained livers showed the suitability of our developed platform, but also the challenges that need to be overcome and further investigated concerning the condition of the slaughterhouse obtained livers. New experiments and investigations are already planned for the coming year to get step by step closer to a long-term functional liver model.

Read more on the BioLiver platform development in our Sinergia Project Case page.

PhysioHeart™ beating heart platform

We’ve also learned quite a lot on our ex-vivo perfused heart model PhysioHeart™. We have found a close collaboration on cardiac perfusion and preservation in the RegMedXB project, with the ultimate goal being regeneration of the heart as an alternative to donor heart transplantation. We’re investigating storage temperatures and perfusion during transport, and their effects on revival rate and maintaining physiological cardiac performance levels in the first few hours following reperfusion. And we’ve celebrated our 50th PhysioHeart experiment within this project earlier this year.

Another milestone we’ve achieved was our very first PhysioHeart experiment in the USA! It was a very exciting challenge to get all the preparations done in time, but it was a great success! We now hope to successfully offer such experiments to our US-based clients in the years to come. Read more in our newsitem!

More to come

In the near future, we will focus our attention to cardiac electrophysiology. We have joined another European Research Project called SIGNET, which is focusing on MR-guided interventions. We will apply the PhysioHeart platform to study electrophysiology of the tissues and the tissue response on ablation therapy. This will open new opportunities for electrophysiological interventions and studies on devices used for these treatments. Feel free to reach out for more information on this project, or on experimental cardiac MRI studies using our PhysioHeart platform – such as 4D flow visualization in a beating heart.

The projects mentioned above, such as Sinergia, RegMedXB or SIGNET, are examples of our efforts on prolonging organ-based experiments and making them physiologically relevant as an alternative to some animal research. If you're in need of ways to study tissue response to your intervention but not yet ready for animal trials, we can support you.

Live Events

EACTS

We were really happy with the live face-to-face meetings that were possible again around the summer period. It was great to take part in exhibition demonstrations around scientific conferences; we supported NeoChord and AMT Medical at the Barcelona conference of the European Association for Cardio-Thoracic Surgery where we brought our “tiny” CBS platform for hands-on demonstration of valve repair and coronary bypass interventions. Read the newsitem here.

Annual conference Dutch Society of Cardiologists

Similarly, we were present at the annual conference of the Dutch Society of Cardiologists (NVVC) in Arnhem where we provided hands-on interaction for the Carrilon mitral valve reshaping live on the Cardiac Dimensions booth. It was great to be able to support the Cardiac Dimensions team again!

Read more in our announcement of the event.

And last-but-not least, we were able to join the SINERGIA consortium in physical presence during a consortium meeting in Brno – which led to very interesting discussions on the progress of the individual projects on advanced technologies for drug discovery and precision medicine. New ideas and collaborations are already in the making following this event.

 

In the assessment of device technology, or clinical training, there is nothing like hands-on interaction on a realistic simulator. If you’re involved in device technology development and wish to showcase to key players in the field on an event where your target audience is present, feel free to reach out to discuss the opportunities our team may provide!

 

Although it is not LifeTec’s primary ambition to publish scientific work, we can only be proud of our partners that report on their scientific advances, findings and results that they achieve by working with our team and advanced simulators. This year, that was no different, and we’re happy to share these publications.

 

  • "Proof of principle of a novel co-pulsating intra-ventricular membrane pump" - by Daniel van Dort (link)
     
  • "Feasibility of a Mitral Annuloplasty With the Capability for Peri- and Postoperative Adjustment." - by Jacob Brubert (link)
     
  • "The Impact of Biomedical Engineering on the Development of Minimally Invasive Cardio-Thoracic Surgery" - by Riccardi Cocchieri (link)
     
  • "Ultrastructural Characteristics of Myocardial Reperfusion Injury and Effect of Selective Intracoronary Hypothermia: An Observational Study in Isolated Beating Porcine Hearts" - by Mohamed El Farissi (link)

 

Older projects that have led to publications can be found in our papers section.

Merry Christmas and a Happy New Year!

We conclude this year by wishing you all a Merry Christmas, hoping that you can spend some valuable moments with your loved ones! Let’s us hope that the New Year will bring good things and that we may meet each other in good health!

A word from our CEO

With the Holiday season coming, it is now time for joy and family happiness. Time to relax and recharge our batteries, and to reflect on what has happened and what has been achieved in the past year.

Despite the many restrictions and obstacles faced even today, I'm proud that we've made great  progress in realizing our goals. A big thank you to the entire team of colleagues, partners and clients for making this happen together. It’s with pleasure and satisfaction that we look back at all that we have been able to accomplish in 2021. These successes are the result of the wonderful people that make them happen.

Head of MedTech Innovation

Marco Stijnen

Head of Research & Training

Linda Kock

Medical Director

Bas de Mol

R&D Engineer

Marcel Wijlaars

Senior Research Engineer

Sjoerd van Tuijl

Office Manager

Janneke Cuijpers

R&D engineer

Elke van Soest

CEO

Jurgen de Hart

R&D engineer

Dave Wanders

R&D Engineer

Bart Smeets

R&D Engineer

Alicia Ruppelt

Project Manager and Engineer

Anke Waterschoot

R&D Engineer

Bertus van de Wetering

Contact Marco if you would like to know more about LifeTec Group!

Head of MedTech Innovation
Marco Stijnen
Call at +31 6 39279777 or e-mail us

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