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Finja Borowski, Sebastian Kaule, Jan Oldenburg, Klaus-Peter Schmitz, Alper Öner, and Michael Stiehm, tm - Technisches Messen

Durability of transcatheter aortic valve replacement (TAVR) could be limited by leaflet thrombosis. A commercially available pulse duplicator system (ViVitro Inc., Victoria, BC, Canada) was used to generate physiological flow and pressure conditions of the cardiovascular circulation. Since commissural alignment in TAVR has only recently become the focus of clinical research, there is a clear gap in understanding the long-term clinical impact of commissural alignment.

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Sofia Di Leonardo, Danila Vella, Carmelo Savio Grillo, Carla Martorana, Salvatore Torre, Vincenzo Argano, Gaetano Burriesci, European Journal of Cardio-Thoracic Surgery, ezad040

This work investigates the impact of the valve-sparing technique on the aortic valve function. The hydrodynamic performance assessment of each implant was conducted in-vitro on a hydro-mechanical pulse duplicator. This shows that, despite providing generally good performance, current valve sparing techniques are still suboptimal and far from matching the physiological leaflets dynamics.

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Robert J Melder, Filippo Naso, Francesco Nicotra, Laura Russo, Ivan Vesely, Sugat R Tuladhar, Antonio M Calafiore, Peter Zilla, Alessandro Gandaglia, Sotiris Korossis, European Journal of Cardio-Thoracic Surgery, ezac583

This study was to evaluate the impact of a polyphenols-based treatment on the extrinsic mechanisms responsible for early BHV degeneration. The hydrodynamic performance of the polyphenolic-treated and untreated T-GT commercial BHVs was assessed under simulated pulsatile flow in a Vivitro Pulse Duplicator System. The treatment is chemically stable, improves tissue extensibility, and effectively stabilizes glutaraldehyde.

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Yuanjia Zhu, Matthew H. Park, Annabel Imbrie-Moore, Robert Wilkerson, Sarah Madira & Y. Joseph Woo, Journal of Cardiothoracic Surgery volume 17, Article number: 303 (2022)

Aortic regurgitation (AR) is one of the most common cardiac valvular diseases, and it is frequently caused by cusp prolapse. The simulator contains a programmable pulsatile linear piston pump (ViVitro Superpump, ViVitro Labs) and a viscoelastic impedance adapter (ViVitro) that is comprised of two compliance chambers and a fixed resistance element and generates a physiologic ventricular waveform. In this study, we successfully designed a commissure geometric alignment device that can manipulate aortic commissure positions to induce aortic cusp prolapse.

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Feng Guo, Rizheng Han, Jishan Ying, Zeping Zhang, Rui Yang, Xing Zhang, Journal of Materials Science & Technology, Volume 144, 1 May 2023, Pages 178-187

In this work, bioinspired anisotropic polymeric heart valves were fabricated using composite materials from polyurethane (PU) and natural cellulose fiber bundles. The hydrodynamic performance of the polymeric valve was evaluated by the ViVitro Pulse Duplicator system. Our results demonstrate the potential application of bioinspired anisotropic CPU composites as polymeric heart valves.

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Maria Rocchi, Marcus Ingram, Piet Claus, Jan D'hooge, Bart Meyns, Libera Fresiello, Artif Organs. 2022; 00: 1– 13

The aim of this review is to provide an overview on Mock Circulatory Loops and to discuss the recent developments of 3D anatomical models for cardiovascular Medical Device testing. One example is the ViVitro Pulse Duplicator system. The simulator is provided with a flexible ventricular sac activated by a piston pump. The addition of 3D anatomical models enables more realistic connections of the Medical Device with the implantation site and enhances the testing capabilities of the Mock Circulatory Loop.

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Shannen B. Kizilski, Xiaoya Zhang, Nicholas E. Kneier, Martha D. Chaillo Lizarraga, Noah E. Schulz, Peter E. Hammer & David M. Hoganson, Cardiovascular Engineering and Technology (2022)

The aim of this study was to develop a robust in vitro system for quantifying flow conditions after various RVOT interventions. The MCL was developed around the ViVitro Pulse Duplicator System with the viscoelastic impedance adapter and ventricle chamber attachments. The 3D-printed RVOT anatomical model and in vitro pulmonary circulatory loop developed in this work provide platform for planning and evaluating surgical interventions in the pediatric population.

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Diya Wang, Boris Chayer, François Destrempes, Jonathan Porée, Marie-Hélène Roy Cardinal, François Tournoux, Guy Cloutier, IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control (Volume: 69, Issue: 12, December 2022) Page(s): 3284 - 3296

Assessment of myocardial contractility during a stress test is of high clinical value for the diagnosis and evaluation of cardiovascular diseases, especially coronary disease and heart failure. Both ends of this left-ventricular mimicking phantom (wall thickness of 15 mm) was then connected to polyvinyl chloride tubing by a pair of loosely attached steel clamps to a pulse duplicator (model #SD2001-1, ViVitro systems Inc., Victoria, BC, Canada). The complex, large, and rapid myocardial deformation during stress tests were also accurately imaged by the proposed strain estimator with close agreement with sonomicrometry.

Other Products Cited:  Endovascular Simulator  Pulsatile Flow Simulation  SuperPump  Ultrasound Measurements

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Luca Rosalia, Caglar Ozturk, Jaume Coll-Font, Yiling Fan, Yasufumi Nagata, Manisha Singh, Debkalpa Goswami, Adam Mauskapf, Shi Chen, Robert A. Eder, Efrat M. Goffer, Jo H. Kim, Salva Yurista, Benjamin P. Bonner, Anna N. Foster, Robert A. Levine, Elazer R. Edelman, Marcello Panagia, Jose L. Guerrero, Ellen T. Roche & Christopher T. Nguyen, Nature Biomedical Engineering volume 6, pages 1134–1147 (2022)

Advances in soft robotics have led to the development of high-fidelity simulators of pathophysiology for biomedical applications. An MCL was built using a pulsatile pump (SuperPump, ViVitro Labs), an anatomically accurate compliant silicone aortic vessel (E ≈ 1 MPa, United Biologics) connected to two adjustable compliance chambers (that is, ventricular, systemic), and a resistive valve. The models leverage haemodynamic mimicry and may facilitate the development of patient-specific applications. The models could also facilitate the clinical translation of treatments; in particular, a cohort of AS patients could be recapitulated in an in vivo porcine model, and new treatments could be evaluated preclinically.

Other Products Cited:  Endovascular Simulator  Ex ViVo Simulation  Flow Visualization  Pulsatile Flow Simulation  SuperPump  Tissue Engineering

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Lawrence N. Scotten, Rolland Siegel, David J. Blundon, Marcus-André Deutsch, Terence R. P. Martin, James W. Dutton, Ebrahim M. Kolahdouz, Boyce E. Griffith

To demonstrate a clear link between predicted blood shear forces during valve closure and thrombogenicity that explains the thrombogenic difference between tissue and mechanical valves and provides a practical metric to develop and refine prosthetic valve designs for reduced thrombogenicity. Incorporated as Vivitro Systems Inc (VSI), our primary focus was research, design and development of cardiac valve implant devices and on the laboratory test systems required. In 2009, work transitioned into a separate independent research and development enterprise, ViVitro Laboratories Inc. (VLI). The application of unique technology, rapid prototyping and ranking of flow velocity patterns near valve closure optimized experimental valve geometry for reduced thrombus potential compared with control valves.

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David Meier, MD; Geoffrey W. Payne, MSc, PhD; Leila B. Mostaço-Guidolin, PhD; Rihab Bouchareb, MSc, PhD; Courtney Rich, BASc; Althea Lai, BSc; Andrew G. Chatfield, MB ChB; Mariama Akodad; Hannah Salcudean, MSc; Georg Lutter, MD; Thomas Puehler, MD; Philippe Pibarot, DVM, PhD; Keith B. Allen, MD; Adnan K. Chhatriwalla, MD; Lars Sondergaard, MD; David A. Wood, MD; John G. Webb, MD; Jonathon A. Leipsic, MD; Janarthanan Sathananthan, MPH, MBChB; Stephanie L. Sellers, MSc, PhD, EuroIntervention 2022;17:1-1

To assess the impact of bioprosthetic valve fracture (BVF) timing on long-term transcatheter heart valve (THV) durability. Valve testing was performed in the ViVitro Labs testing facilities (ViVitro Labs Inc, Victoria, Canada). Hydrodynamic testing was performed using a commercially available pulse duplicator (ViVitro Labs Inc, Victoria, Canada), meeting the equipment requirements defined in ISO 5840-3 for pulsatile flow testing (16) (Figure 1A). In this bench study, the ACn and the S3 showed acceptable hydrodynamic performances after AWT to 200M cycles, equivalent to 5 years, irrespective of BVF timing compared to no fracture.

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Lisa Carlson Hanse, Marcell J Tjørnild, Simon G Sørensen, Peter Johansen, Ignacio Lugones, Vibeke E Hjortdal, Interactive CardioVascular and Thoracic Surgery, Volume 35, Issue 4, October 2022, ivac227

We investigated a new surgical technique of trileaflet semilunar valve reconstruction possessing the potential of remaining sufficient and allowing for some growth with the child. Pulsatile flow was produced by a Series piston pump (SuperPump AR; ViVitro Labs, Victoria, Canada), connected to the ventricular chamber. TSVR was achievable in vitro. Hydrodynamic pressure and echocardiographic evaluations demonstrated a sufficient and non-stenotic neo-valve.

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David Meier, Mariama Akodad, Andrew G. Chatfield, Georg Lutter, Thomas Puehler, Lars Søndergaard, David A. Wood, John G. Webb, Stephanie L. Sellers, and Janarthanan Sathananthan, J Am Coll Cardiol Intv. 2022 Aug, 15 (15) 1532–1539

The aim of this study was to assess the impact of commissural misalignment (CMA) on hydrodynamic function following VIV intervention with the ACURATE neo THV using a bench model. In VIV using the ACURATE neo THV at deep implantation, increasing degree of CMA was associated with THV leaflet interaction with those of the surgical valve and worsening regurgitant fraction. THV leaflet interaction was prevented when there was CA.

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K.Yu. Klyshnikov, E.A. Ovcharenko, Yu.A. Kudryavtseva, L.S. Barbarash, RUSSIAN JOURNAL OF TRANSPLANTOLOGY AND ARTIFICIAL ORGANS, Vol. XXII, No 2–2020

The aim of the study was an in vitro hydrodynamic study of the developed prosthetic heart valve of the second generation, designed to carry out an implantation using “valve-in-valve” method. ...Prototypes of the developed prosthesis were studied under simulated physiological conditions of the heart using a Vivitro Labs pulse duplicator (Canada) in a comparative aspect with “UniLine” clinical commercial aortic valve bioprosthesis (Russia)... ...The design of the prosthesis under development has shown its consistency in terms of functional characteristics, both in comparison with the original UniLine prosthesis and with literature data....

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Emily N. Boice, David Berard, Jose M. Gonzalez, Sofia I. Hernandez Torres, Zechariah J. Knowlton, Guy Avital, Eric J. Snider, Bioengineering 2022, 9(7), 319

Central vascular access (CVA) may be critical for trauma care and stabilizing the casualty. However, it requires skilled personnel, often unavailable during remote medical situations and combat casualty care scenarios. Automated CVA medical devices have the potential to make life-saving therapeutics available in these resource-limited scenarios, but they must be properly designed. Unfortunately, currently available tissue phantoms are inadequate for this use, resulting in delayed product development. ...A SuperPump (ViVitro Labs, Victoria, BC, Canada) was used for generating pulsatile, cardiac mimicking arterial flow within the flow loop test platform (Figure 1D)... ...In conclusion, the tissue phantom model presented addresses a current testing gap for developing central vascular access medical devices. Troubleshooting is essential and having to rely on live, or even ex vivo, animal testing for evaluating a medical device with physiological mimicking fluid flow or pressure levels will slow device development...

Other Products Cited:  Endovascular Simulator  Pulsatile Flow Simulation

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Paulo Yu, Vibhav Durgesh, Experimental Thermal and Fluid Science, Vol 138, October 1 2022

Aneurysms are abnormal expansion of weakened blood vessels which can be debilitating or fatal upon rupture. Previous studies have shown that hemodynamics play a role in aneurysm formation, growth and rupture. Therefore, the objective of this work is to investigate the impact of flow structures on vortex strength, impinging location, and wall shear stress for two aneurysm models. ...The inflow parameters used in this study, and , were controlled using a ViVitro Labs Inc. SuperPump system... ...The flow evolution results showed that impacted the vortex formation, growth, and dissipation processes for the studied aneurysm model...

Other Products Cited:  Analysis and Computational Modeling  Flow Visualization  Pulsatile Flow Simulation  Stent Testing  SuperPump

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Libby H. Welborn, Anna K. Himes, Ida E. Greenlee, Nyna J. DeWitt, Ava T. Burgess, Brandon K. Eberl, Olga Pierrakos, 2022 Systems and Information Engineering Design Symposium (SIEDS)

The aim of this paper is to: 1) showcase the design process of a quadleaflet ePTFE valved conduit with a diameter of 16mm or less and 2) offer a hemodynamic performance comparison. ...The proposed valve was tested using the ViVitro Pulse Duplicator under physiologic cardiac conditions... ...A comparison between the two ePTFE handmade valves (trileaflet and quadleaflet) demonstrated hemodynamic differences in regurgitation due to leaflet number. The handmade valves both showed increased regurgitation compared to a Carbomedics valve (commercially available design). Regurgitation had varying effects on pressure gradients and cardiac output...

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K.Yu. Klyshnikov, P.S. Onischenko, Е.А. Ovcharenko, СТМ, 2022, vol. 14, No.2

The aim of the study was to study the complex biomechanics of the aortic valve prosthesis and to analyze the effect of frame mobility on the stress-strain state and geometry of the valve leaflet apparatus using a numerical simulation method, which reproduces the qualitative and quantitative results of its bench tests. ...The simulation was validated by comparing the results of numerical and bench simulation on the ViVitro Labs hydrodynamic system (ViVitro Labs Inc., Canada)... ...The results of the UniLine prosthesis biomechanics modeling have demonstrated that mobility of the frame struts of the heart valve prosthesis is a crucial aspect in assessing the effectiveness of the leaflet apparatus geometry and may be a negative factor in case of a highly elastic leaflet material...

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Paulo Yu, Vibhav Durgesh, Fluids, 2022, 7, 165.

Aneurysms are localized expansions of blood vessels which can be fatal upon rupture. Studies have shown that aneurysm flows exhibit complex flow phenomena which consist of single or multiple vortical structures that move within the flow cycle. ...Rep and α were the inflow parameters used to match and simulate the conditions in the human circulatory system. These inflow parameters were precisely controlled with a ViVitro Labs Inc. SuperPump system... ...Both POD and DMD are capable analysis tools to investigate the spatial and temporal behavior of large-scale structures of a given flow field. POD and DMD can be used to create mathematical models to look into the flow evolution in sufficiently high detail and at any time step...

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Salwa B. Anam, Brandon J. Kovarovic, Ram P. Ghosh, Matteo Bianchi, Ashraf Hamdan, Rami Haj-Ali & Danny Bluestein - Cardiovascular Engineering and Technology (2022)

Bicuspid aortic valve (BAV) is the most common congenital cardiac malformation, which had been treated off-label by transcatheter aortic valve replacement (TAVR) procedure for several years, until its recent approval by the Food and Drug Administration (FDA) and Conformité Européenne (CE) to treat BAVs. ...Materials and Methods Patient-specific in silico models and 3D printed replicas of 3 BAV patients with different degrees of post-TAVR paravalvular leakage (PVL) were created. Patient-specific TAVR device deployment was modeled in silico and in vitro—following … ...PVL degree and locations were consistent with the clinical data. Cross-validation comparing the stent deformation and the flow parameters between the in silico and the in vitro models demonstrated good agreement....

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