Safety Devices Research Articles

Integrated Approach To Material Parameterization And Inflation Control Of Hyperelastic Membrane For Artificial Left Ventricle Development

Abstract In transitioning from conventional mechanical to biomedical applications, the choice of materials becomes critical. While hard materials like steel offer durability, their compatibility with biological systems, particularly blood, is limited due to the risk of cell damage. To address this, our research focuses on soft membrane-based systems to minimize haemolysis and optimize blood flow. By prioritizing biocompatibility and gentle interactions, our approach aims to enhance the safety and effectiveness of biomedical devices. Through innovative solutions in material selection and system design, we aim to advance cardiovascular medicine and contribute to the broader field of biomedical engineering.

Efficacy and safety of the OverStitch endoscopic suturing device for closure of defects after endoscopic submucosal dissection: a systematic review and meta-analysis

Background and AimsEndoscopic submucosal dissection (ESD) is used for closure of gastrointestinal (GI) lesions following endoscopic resection techniques such as endoscopic mucosal resection. Generally, a large defect is left that can increase the risk of postprocedural bleeding or perforation, and has been managed by techniques such as endoscopic placement of clips to reapproximate the defect edges. An over the scope suturing system (OSS), Overstitch created by Apollo endosurgery, has been designed for similar utility in ESD closure. Its design intent aimed for full thickness closure and exchange of suture without endoscopic removal. This paper aims to evaluate the technical success and efficacy of use of OSS in the closure of ESD. MethodsA comprehensive literature review across multiple databases was performed. Studies including Overstitch and ESD information were evaluated, with 7 articles meeting predetermined eligibility of quality for inclusion. Statistical analysis was completed using CMV v 3.0 software. The primary evaluated endpoint was technical success and efficacy of instrument use in patients undergoing ESD closure with OSS. The secondary evaluated endpoint was the overall rate of adverse events related to the use of OSS. ResultsOverall, the pooled rates for instrumental efficacy and technical success were 95.8% (95% CI: 80.6%, 99.2%; P=0.04) and 99.2% (95% CI: 79.8%, 100.0%; P=1.00), respectively. The pooled rate of adverse events was 0.9% (95% CI: 0.0%, 24.8%; P=0.99) with pain reported as the most common adverse event. ConclusionsThe OSS system appears to be an effective and safe tool in the closure of defects after ESD. However, its design also makes it quite large and difficult to maneuver. While it allows for replacement of the suture kit without endoscopic removal, there have been multiple reported episodes of device failure. Further randomized controlled trials warranted as OSS becomes more widely used.

TCT-154 Early Safety and Feasibility Study of a Novel Transcatheter Aortic Valve Replacement Device With Polymer Leaflets in Treating Patients With Severe Calcific Aortic Stenosis: Sekilia Valve

TCT-154 Early Safety and Feasibility Study of a Novel Transcatheter Aortic Valve Replacement Device With Polymer Leaflets in Treating Patients With Severe Calcific Aortic Stenosis: Sekilia Valve

TCT-381 Safety and Effectiveness of a Novel Intravascular Lithotripsy Device Using the Hertz Contact Stress Mechanism for Calcium Fragmentation: Six-Month Outcomes of the PINNACLE I Clinical Trial

TCT-381 Safety and Effectiveness of a Novel Intravascular Lithotripsy Device Using the Hertz Contact Stress Mechanism for Calcium Fragmentation: Six-Month Outcomes of the PINNACLE I Clinical Trial

Synergistic coating of Laponite swollen-layer and heparin composite for enhanced antifouling and antithrombotic performance

When implantable medical devices come into contact with blood, acute thrombosis and inflammation often occur due to the adhesion and denaturation of plasma proteins, ultimately degrading device performance. To address this issue, we developed a gel-like coating with superhydrophilic properties, incorporating a heparin based outer layer designed to minimize foreign body reactions and enhance hemocompatibility. The coating was engineered using a layer-by-layer (LbL) assembly of poly-l-lysine (PLL), laponite (Lap), and heparin (Hep), utilizing electrostatic interactions. The successful formation of stable layers was confirmed by QCM-D analysis. The inner layer, composed of PLL/Lap multilayers, formed a gel-like structure that maintained superhydrophilicity and effectively prevented cell adhesion. The outermost PLL/Hep multilayers significantly suppressed thrombus formation by inhibiting plasma protein and red blood cell adsorption as well as platelet activation. The coating exhibited excellent stability, retaining its superhydrophilic properties and heparin functionality even after 7 days of immersion in DPBS. Additionally, in vitro hemocompatibility and cytocompatibility tests confirmed its non-toxicity and overall biocompatibility. These results highlight the potential application of this coating to various implantable medical devices, providing a robust solution for improving device performance and safety.

Emergence of Mycobacterium gordonae in heater cooler units: a five-year prospective surveillance on devices frequently subjected to chloramine-T booster disinfection

Worldwide, the detection of Mycobacterium chimaera in LivaNova heater-cooler units (HCUs) has led to their replacement with other HCUs, although non-tuberculous mycobacteria (NTM) have been reported also for HCUs produced by other manufacturers. In almost all hospitals of our region, LivaNova HCUs have been replaced with Maquet HCU40s, regularly disinfected with chloramine-T. To report the results of the surveillance over a 63-month operation period of the Maquet devices, and to provide a trend in NTM positivity over time. Twenty-nine Maquet devices (HCU40 and HU35) were monitored by two culture methods and PMA-PCR method. The trend in NTM positivity rate was evaluated through the Locally Estimated Scatterplot Smoothing regression and then modelled over time through segmented logistic regression. The data acquired during the study period demonstrate a remarkable increase in the positivity rate, especially after their third year (maximum slope change at 1280 days). Non-tuberculous mycobacteria were isolated in 150 water samples (37.2%); 100% and 62% of HCU40 and HU35 devices respectively were colonized with non-tuberculous mycobacteria. The most frequently detected species were Mycobacterium gordonae (73%) followed by Mycobacterium chelonae (41%) and Mycobacterium paragordonae (11%). Preventive strategies by disinfection with chloramine-T did not effectively reduce non-tuberculous mycobacteria colonization of Maquet devices. Although, to date, no cases of post-operative invasive infections linked to Maquet devices have been reported, our microbiological results emphasize the need for 1) designing changes to increase safety of devices and 2) researching and developing new disinfection protocols including alternative molecules.

Medical Ozone as a Therapeutic Option in Musculoskeletal Pain Control: A Critical Review of Clinical Trials Considering Safety and Quality Indicators for Procedures and Devices.

Background: Drug therapies have been widely applied for pain management, however, there are important side effects such as those related to corticosteroids and opioids. Recent studies demonstrated promising results using medical ozone as a safe, effective, and low-cost intervention for pain control. Objective: to review and critically analyze clinical studies that used ozone therapy for musculoskeletal pain. Methods: a literature search of various databases was performed to identify relevant studies. From a total of 249 records, 27 studies were included. Quality indicators, human and device factors that strongly influence the generation of evidence were considered, such as study design and device safety. We also mitigated biases, considering the safety and efficacy of the intervention itself. Results: Regarding safety, 77 (8%) of studies reported no adverse effects; concerning efficacy outcomes, medical ozone shows to be an effective intervention on musculoskeletal pain control. Important information about used devices were missing. Conclusions: medical ozone shows to be safe and effective; qualification of health professionals as well as the device safety are mandatory. However, there is a lack of requirements to identify the best therapeutic scheme; further longer, clinical and rigorous trials are needed.

IoT-Based Women Safety Device

Abstract: Women's Safety has always been a major problem even in these modern times with a lot of advancements in technology. The existing system provides safety bands for women which can be activated either manually or automatically, but both options are not available leading to more chances of false alarms. The proposed system “IoT-based Women Safety Device” mainly focuses on providing a reliable, fast and very effective system for the safety of women. It provides a platform that will be actively available 24/7 for their help to avoid any unfortunate situations. The user can activate the device manually by pressing the activation button or automatically depending upon pulse rate and motion sensor value. On activation, the location of the user can be traced using the GPS module and alert messages will be sent to registered contacts using the GSM module. The mobile application remains connected to the Safety Device for User Authentication and storing user data in the Firebase real-time database.

Preclinical evaluation of a novel endovascular thrombectomy device in a modified swine model for iliac vein thrombosis

ObjectiveTo evaluate the safety and efficacy of a novel endovascular thrombectomy device in a modified swine model of iliac vein thrombosis. MethodsA modified swine model for iliac vein thrombosis was created using proximal‒distal balloon occlusion combined with autologous venous thrombus and thrombin injections. The safety and efficacy of the newly developed Zylox endovascular thrombectomy system were evaluated in this animal model and its performance was compared with that of the AcoStream aspiration thrombectomy device. ResultsBilateral iliac vein thrombosis models were successfully created in 12 swine, with 23 iliac veins used for device testing and one for anatomical observation. The thrombus length in the Zylox group was greater than in the AcoStream group (98.42 ± 17.56 mm vs. 84.12 ± 13.30 mm), while thrombus scores were not significantly different between the two groups. Although Grade I thrombus clearance was achieved in all iliac veins in both groups, blood loss in the Zylox group was significantly less than in the AcoStream group (81.09 ± 27.26 ml vs. 162.50 ± 61.96 ml, P < 0.001). Three swine (6 iliac veins) in each group underwent repeat venography evaluations 28 days postthrombectomy, showing that all the veins were patent without any rethrombosis. Histopathologic evaluation immediately and 28 days postthrombectomy revealed no differences between the two groups. No complications or deaths occurred in the swine during the entire process. ConclusionThe current modified swine model is stable, reproducible, and appropriate for testing endovascular devices. This study preliminarily verified the safety and efficacy of the Zylox thrombectomy system for thrombus removal in this animal model and demonstrated its advantage in controlling blood loss. Future randomized controlled trials in humans are needed to further verify the safety and efficacy of the device.

Cu-doped Fe3O4 supported on porous NC-coated carbon cloth for robust flexible nickel–iron batteries

The pursuit of safe, cost-efficient, environment-friendly and portable energy storage devices has greatly stimulated the exploitation of aqueous flexible batteries that are green and stable. Ni-Fe aqueous batteries have become an ideal choice for flexible energy storage devices due to the advantages such as large theoretical capacity, good safety and low cost. In this work, Fe3O4 is chosen as the active material for the anode of Ni-Fe batteries, which is grown on a modified carbon cloth of PNC/CC with a coating layer of porous nitrogen-carbon. The PNC/CC, as a flexible current collector, has higher hydrophilicity, porosity and conductivity. To further improve the electronic conductivity, ionic adsorption ability, morphology and capacity of the Fe3O4 anode, Cu2+ is added during Fe3O4 growth, which not only brings more homogeneous and full coverage of spherical Cu/Fe3O4 particles on PNC/CC, but also greatly lowers its electrode–electrolyte charge transfer resistivity, increases its ionic diffusion and accelerates its redox reaction activity. With optimized electrochemical reactions, the Cu/Fe3O4@PNC/CC anode shows a much higher capacity of 170.7 mAh/g than bare Fe3O4/CC anode (1 A/g). Solid-state aqueous Ni-Fe batteries are assembled using the Cu/Fe3O4@PNC/CC anode and a NiCoLDH cathode, exhibiting a capacity of 88.56 mAh/g at 1 A/g, capacity retention of 88.19 % during 2000 cycles, as well as the energy density reaching 96.6 Wh kg−1 and the power density reaching 9.7 kW kg−1. Moreover, flexible Ni-Fe battery devices are also fabricated, which can maintain relatively stable electrochemical performance at various bending angles and low temperatures. This works brings some insights for the synthesis and modification of Fe3O4-based anodes for flexible and solid-state Ni-Fe batteries.

Experimental and numerical investigation of wave loads on land-based multi-chamber OWC converters

Capturing more wave energy in a cost-effective principle has become a challenging task. Multi-chamber oscillating water column (OWC) devices are gradually gaining favour due to their potentially efficient characteristics. However, there is relatively limited research on dynamic analysis which is crucial for the safety and survival of multi-chamber OWC devices. In the study, model experiments of the hydrodynamic pressures for single-, dual- and three-chamber devices were conducted at a wave flume. A two-dimensional fully nonlinear numerical model for the interaction between waves and the OWC devices was established based on the higher-order boundary element method. The numerical results well cross-validated the experimental data. The wave forces and moments exerted on the devices were numerically calculated. The results indicate that the multi-chamber configurations not only generally reduce the wave loads on front and rear walls in high-frequency waves, but also avoid the sloshing motion of the water column inside the chamber, which induces large wave loads on the converter. However, the additional internal walls impose a redoubled burden on the junction of the top ceiling and the rear wall. The OWC converters sustain the horizontal forces much more than vertical forces. The front lip (i.e., the bottom edge of the front wall), the rear wall and the connection between the seabed and the device are relatively dangerous positions for configurations with any number of chambers.

Enhancing the state-of-charge estimation of lithium-ion batteries using a CNN-BiGRU and AUKF fusion model

Accurate estimation of lithium-ion batteries’ state of charge (SOC) is crucial for the safety of energy storage devices, preventing issues such as overcharging or discharging. This paper introduces a fusion model combining convolutional neural network (CNN), bidirectional gated recurrent unit (BiGRU), and adaptive unscented Kalman filter (AUKF). This method's advantage lies in integrating Kalman filtering with the benefits of neural networks, eliminating the need for complex hyperparameter tuning and battery model construction. Initially, CNN-BiGRU maps variables like voltage, current, and temperature to SOC for initial estimation. The AUKF algorithm then filters these SOC outputs, minimizing fluctuations and enhancing accuracy. This approach ultimately leads to precise and stable SOC estimates. To validate the model's effectiveness, lithium-ion battery datasets across various temperatures were extensively trained and tested. The CNN-BiGRU-AUKF model demonstrated consistent performance under these conditions, with a maximum MSE of 0.00011, MAE under 0.0092, Max AE around 0.02, and a maximum RMSE of 0.017. Compared to similar methods, the proposed approach demonstrates superior SOC estimation accuracy and computational efficiency. Additionally, the model's scalability was validated using training and testing data for SOC estimates from a different type of lithium battery.

Research on Multiphysics-Driven MEMS Safety and Arming Devices.

As the core component of energy transfer in weapon system, safety and arming (S&A) devices affect the safety, reliability, and damage ability of the weapon. Micro-electromechanical systems (MEMS) S&A devices have been widely investigated for their smaller structure size, higher functional integration, and better smart functionality. This paper proposes the design of a multi-physics field-driven MEMS S&A device. The S&A mechanism is composed of a setback mechanism, a spin mechanism, and an electrothermal mechanism, achieving multiphysics-arming. With the coordination of the three mechanisms, the S&A device can produce a 1 mm displacement. The displacement generated allows the S&A device to switch between safety status and arming status. The unlock conditions and overload resistance of each mechanism are obtained by finite element simulation. Based on SOI wafers and silicon oxide wafers, the chips were fabricated and packaged. Several tests were carried out to verify the working condition and overload resistance of the S&A device. The result shows that under a voltage of 11 V and a rotation speed of 8000 r/min, with a size no more than 10 mm × 10 mm × 1.5 mm, the device works smoothly and can withstand an overload of 25,000 g.

Efficacy and Safety of a Home-Use Light-Emitting Diode Neck Device for Improvement in Neck Wrinkles: A Multicenter, Randomized, Double-Blind, Sham Device, Superiority Verification, Confirmatory Clinical Trial.

Light-emitting diode (LED) light sources have become an increasingly popular choice for the treatment and rejuvenation of various dermatological conditions. This study aimed to evaluate the effects of neck rejuvenation, patient satisfaction, and the safety of LED application to the neck in an Asian population. This was a multicenter, randomized, double-blind, sham device study. Seventy participants were enrolled in the study. The participants wore the home-use LED neck device for 9 min a day, 5 times a week, for a total of 60 sessions. The Lemperle Wrinkle Scale (LWS) and Global Aesthetic Improvement Scale (GAIS) were used to evaluate the results of both investigators and participants. The thyroid gland was examined using ultrasonography to evaluate the safety of the investigational device. The percentage of participants with improved LWS at Week 12 was significantly higher in the study group. Additionally, the percentage of participants with improved LWS was significantly higher in the study group at Weeks 8, 12, and 16. The LWS at Week 12 corrected with baseline values was found to be significantly different between the two groups. GAIS showed significant differences at 8, 12, and 16 weeks in the investigators' evaluation but not in the participants' evaluation. Repeated-measures analysis of variance at Weeks 4, 8, 12, and 16 also confirmed a significant difference between the two groups only in investigator assessment. No significant thyroid-related complications were observed. LED application to the neck may be considered a satisfactory and safe procedure for neck rejuvenation.

Как обеспечить приоритет профилактических мероприятий в системе государственного контроля качества и безопасности медицинской деятельности: предложения.

In the article, based on the analysis of legislation, the authors formulated a number of proposals, the implementation of which will ensure the priority of preventive measures in the system of state control of the quality and safety of medical activities. It is noted that the priority of a preventive visit, as one of the most important preventive measures, in relation to control (supervision) measures, provided for by the Law on State Control No. 248-FZ, is primarily determined by the quality of the content of the preventive visit. The content of the preventive visit should allow the inspector of the supervisory authority in the field of health protection to identify during the preventive conversation the level of awareness of the controlled person about the mandatory requirements that this person is obliged to comply with. The step-by-step algorithm for carrying out a preventive visit in terms of monitoring the safety of medical devices presented in the article allows the inspector of the supervisory authority in the field of health protection to promptly and reliably obtain information about the level of awareness or lack of awareness of the supervised person about the established mandatory requirements for the activities carried out, and accordingly about their compliance or non-compliance by the supervised person.

Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership

BackgroundRecognizing the limitations of pre-market clinical data, regulatory authorities have embraced total product lifecycle management with post-market surveillance (PMS) data to assess medical device safety and performance. One method of proactive PMS involves the analysis of real-world data (RWD) through retrospective review of electronic health records (EHR). Because EHRs are patient-centered and focused on providing tools that clinicians use to determine care rather than collecting information on individual medical products, the process of transforming RWD into real-world evidence (RWE) can be laborious, particularly for medical devices with broad clinical use and extended clinical follow-up. This study describes a method to extract RWD from EHR to generate RWE on the safety and performance of embolization coils.MethodsThrough a partnership between a non-profit data institute and a medical device manufacturer, information on implantable embolization coils’ use was extracted, linked, and analyzed from clinical data housed in an electronic data warehouse from the state of Indiana’s largest health system. To evaluate the performance and safety of the embolization coils, technical success and safety were defined as per the Society of Interventional Radiology guidelines. A multi-prong strategy including electronic and manual review of unstructured (clinical chart notes) and structured data (International Classification of Disease codes), was developed to identify patients with relevant devices and extract data related to the endpoints.ResultsA total of 323 patients were identified as treated using Cook Medical Tornado, Nester, or MReye embolization coils between 1 January 2014 and 31 December 2018. Available clinical follow-up for these patients was 1127 ± 719 days. Indications for use, adverse events, and procedural success rates were identified via automated extraction of structured data along with review of available unstructured data. The overall technical success rate was 96.7%, and the safety events rate was 5.3% with 18 major adverse events in 17 patients. The calculated technical success and safety rates met pre-established performance goals (≥ 85% for technical success and ≤ 12% for safety), highlighting the relevance of this surveillance method.ConclusionsGenerating RWE from RWD requires careful planning and execution. The process described herein provided valuable longitudinal data for PMS of real-world device safety and performance. This cost-effective approach can be translated to other medical devices and similar RWD database systems.

Treatment of intracranial aneurysms using the Tubridge flow diverter.

The Tubridge flow diverter (TFD) was recently developed to treat intracranial aneurysm (IA). In this study, we aimed to assess the safety and efficacy of this novel device. A retrospective cohort of consecutive patients with IA was recruited between June 2017 and February 2022. The studied outcomes were perioperative complications, clinical quality of life, and angiographic IA occlusion. Multivariate logistic regression was performed to explore the potential predictors of perioperative stroke events and IA occlusion. A comprehensive literature review was conducted across five databases for evidence synthesis. Among the patients with IA in our cohort, 144 underwent successful TFD implantation. Postoperative stroke was observed in 11 (7.6%) patients, and 130 (90.3%) patients were discharged with modified Rankin scales (mRS) of ≤2. In the last clinical follow-up (mean, 16.9months), 96.6% of the patients reported a satisfactory quality of life (mRS ≤2). IA occlusion was observed in 84.6% of the patients at the last angiographic follow-up (mean, 10.4months). Aneurysmal subarachnoid hemorrhage [odds ratio (OR), 6.98; 95% confidence interval (CI), 1.11-43.91] and giant IA (OR, 5.63; 95% CI, 1.15-27.48) were associated with perioperative stroke events. The evidence synthesis found high rates of satisfactory quality of life (rate, 98.8%; 95% CI, 97.1-99.9%) and IA obliteration (rate, 78.5%; 95% CI, 74.0-82.7%) after TFD treatment. The pooled complication rate was 13.6% (95% CI, 10.9-16.5%). This study identified a high rate of IA occlusion in patients who received TFD treatment. These patients also reported a satisfactory quality of life. Further studies in larger prospective cohorts with longer follow-up periods are warranted to verify our findings. Key message What is already known on this topic Flow diverter (FD) devices are an optimal tool to modify hemodynamics and treat intracranial aneurysms (IAs). However, the safety and efficacy of a novel self-expanding FD, namely the Tubridge flow diverter (TFD), remain to be fully established owing to the short-term follow-up periods and limited sample size of existing studies. What this study adds In our cohort of patients who received TFD treatment, 96.6% of patients reported satisfactory quality of life at the last clinical follow-up (mean, 16.9months); and 84.6% of IAs were successfully occluded at the last angiographic follow-up (mean, 10.4months). Our comprehensive review and evidence synthesis of existing studies on TFD found high rates of satisfactory quality of life (98.8%; 97.1-99.9%) and IA obliteration (78.5%; 74.0-82.7%). How this study might affect research, practice or policy TFD demonstrated satisfactory performance in the treatment of IAs in our cohort. Studies with larger prospective cohorts and longer follow-up periods are warranted to further investigate this promising novel approach.

Building consensus on clinical outcome assessments for BCI devices. A summary of the 10th BCI society meeting 2023 workshop.

The 10th International Brain Computer Interface (BCI) Society Meeting, 'Balancing Innovation and Translation', was held from the 6th to 9th of June 2023 in Brussels, Belgium. This report provides a summary of the workshop 'Building Consensus on Clinical Outcome Assessments (COAs) for BCI Devices'. This workshop was intended to give participants an overview of the current state of BCI, future opportunities, and how different countries and regions provide regulatory oversight to support the BCI community to develop safe and effective devices for patients. Five presentations and a panel discussion including representatives from regulators, industry, and clinical research stakeholders focused on how various stakeholders and the BCI community might best work together to ensure studies provide data that is useful for evaluating safety and effectiveness, including reaching consensus on clinical outcome assessments (COAs) that represent clinically meaningful benefits and support regulatory and payor requirements. This report focuses on the regulatory and reimbursement requirements for medical devices and how to best measure safety and effectiveness and summarizes the presentations from five experts and the discussion between the panel and the audience. Consensus was reached on the following items specifically related to BCI: (i) the importance of and need for a new generation of COAs, (ii) the challenges facing the development of appropriate clinical outcome assessments, and (iii) that improvements in COAs should demonstrate obvious and clinically meaningful benefit(s). There was discussion on: (i) clinical trial design for BCIs and (ii) considerations for payor reimbursement and other funding. Whilst the importance of building community consensus on COAs was apparent, further collaboration will be required to reach consensus on which specific current and/or novel COAs could be used for the BCI field to evolve from research to market.

Effects of Core Competitiveness on Strategic Alliance and Alliance Performance in Medical Device Industry

Along with the progress of economic development, the enhancement of national income, and the trend of population ageing in past years, people are annually increasing the medical expenses and enhancing the demands for medical devices. Being a part of healthcare, the requirements for the product safety and quality of medical devices are rather high. Manufacturers in the world therefore have to work hard to promote the competitiveness, attempting to achieve corporate goals and supply the best products to medical profession. Core competition combined resources are the sign of competitive advantage. Firms would build excellent competitive advantage through important resource combinations. A company tending to create competitiveness as well as build and lead new markets has to make investment earlier and continuously, apply the imagination to predict, develop, and investigate markets which have not been existed. The research focused on supervisors and employees in the medical device industry. The results reveal notable and positive effects of core competitiveness on strategic alliance and alliance performance, the understanding of how medical device firms apply strategic behavior in the competitive strategic means to reinforce the resource acquisition capability, and the reference for building the competitive advantage after strategic alliance and drafting appropriate competitive strategies for the business management of a domestic firm in medical device industry. It is expected to propose more specific suggestions for firms in medical device industry using core competitiveness in strategic alliance and dedicating to the promotion of competitive advantage.

Hybrid biofabricated blood vessel for medical devices testing

ABSTRACT Current in vitro and in vivo tests applied to assess the safety of medical devices retain several limitations, such as an incomplete ability to faithfully recapitulate human features, and to predict the response of human tissues together with non-trivial ethical aspects. We here challenged a new hybrid biofabrication technique that combines bioprinting and Fast Diffusion-induced Gelation strategy to generate a vessel-like structure with the attempt to spatially organize fibroblasts, smooth-muscle cells, and endothelial cells. The introduction of Fast Diffusion-induced Gelation minimizes the endothelial cell mortality during biofabrication and produce a thin endothelial layer with tunable thickness. Cell viability, Von Willebrand factor, and CD31 expression were evaluated on biofabricated tissues, showing how bioprinting and Fast Diffusion-induced Gelation can replicate human vessels architecture and complexity. We then applied biofabricated tissue to study the cytotoxicity of a carbothane catheter under static condition, and to better recapitulate the effect of blood flow, a novel bioreactor named CuBiBox (Customized Biological Box) was developed and introduced in a dynamic modality. Collectively, we propose a novel bioprinted platform for human in vitro biocompatibility testing, predicting the impact of medical devices and their materials on vascular systems, reducing animal experimentation and, ultimately, accelerating time to market.