Safety Devices Research Articles

Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters

Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters

Comparison of the outcomes between ultrasonic devices and clamping in hepatectomy: a meta-analysis.

Recent advances in ultrasound technology have led to widespread adoption of ultrasonic energy devices in liver resections. While various studies have assessed the comparative advantages of ultrasonic devices and traditional clamp-crushing, their findings vary. Moreover, a specific systematic review on this topic has not yet been conducted. This study aims to present a comprehensive, up-to-date analysis comparing outcomes between ultrasonic devices and conventional clamp-crushing methods in liver resection, based on currently available literature. We conducted a systematic literature search in databases such as PubMed, Embase, Web of Science, and CNKI up to November 2023. Studies that compared the efficacy or safety of ultrasonic devices against traditional clamp-crushing methods in hepatectomy were included. The analysis covered intraoperative outcomes like operating time, blood loss, and transfusion rate, as well as postoperative outcomes such as complication rate, mortality, postoperative bleeding, and bile leakage. Review Manager version 5.3 (Cochrane Collaboration, Oxford, UK) and Stata 17.0 (Stata Corp, College Station, TX, USA) were used for data analysis. Thirteen studies, involving a total of 1,417 patients (630 using ultrasonic devices and 787 using clamp-crushing methods), were included. The clamp-crush method resulted in a shorter operation time. Contrarily, the ultrasonic device group experienced reduced blood loss and lower transfusion rates. Postoperatively, there was no significant difference in mortality or postoperative bleeding between the groups. However, the ultrasonic group had a lower overall complication rate, particularly a reduced incidence of bile leakage. Overall, the ultrasonic devices were associated with improved perioperative outcomes. The findings suggest that ultrasonic devices provide better outcomes in hepatectomy compared to traditional clamp-crushing techniques. Nonetheless, large-scale randomized controlled trials are needed to confirm these results due to potential heterogeneity and biases. The choice of using ultrasonic devices should consider the surgeon's experience and individual patient circumstances.

Constructing Dual Schottky Junctions for High‐Performance Zinc Anode

AbstractAqueous zinc ion batteries provide new solutions for achieving environmentally friendly and safe energy storage devices. Unfortunately, the further application is hampered by the growth of zinc dendrites caused by uneven zinc deposition, hydrogen evolution and other side interfacial reactions at the zinc anode. Herein, a multifunctional Bi‐Bi2O3 hybrid artificial interface layer is constructed on the surface of the zinc anode using an in situ conversion reaction. Among them, the Bi‐Bi2O3 Schottky structure not only significantly accelerates the migration of Zn2+ through its built‐in electric field, but also effectively improves the hydrogen evolution barrier (ΔGH*), thereby suppressing side reactions. Moreover, the Schottky contact formed between the interface layer and the metal zinc interface also regulates the electronic distribution state on the zinc surface and optimizes the deposition process of Zn2+, ensuring a more uniform and orderly zinc deposition process. Based on the synergistic effect of dual Schottky junctions, symmetric batteries achieve stable cycling for 2000 h under the conditions of 1.0 mA cm−2 and 1.0 mAh cm−2. The full cell assembled with α‐MnO2 as the cathode maintains capacity of 112.7 mAh g−1 after 1000 cycles at 1 A g−1 with a capacity retention rate of 84%.

Abstract 4137278: Efficacy and Safety of Left Atrial Appendage Closure Devices in Patients Aged Above 80 Years: A Systematic Review and Meta-Analysis

Background: Limited single-center and observational studies suggest that left atrial appendage occlusion (LAAO) may be a safe alternative in selected elderly patients with AFib. Hypothesis: We hypothesize that patients aged over 80 will have similar rates of complications and the same level of efficacy in stroke prevention as young patients. Aims: This review aims to establish the safety and efficacy of LAAO in octogenarians and nonagenarian patients with AFib. Methods: A systematic search of PubMed, Science Direct, and CENTRAL was performed for studies that reported outcomes comparing octogenarian and nonagenarian patients who underwent LAAo with their younger counterparts. The Review Manager 5.4 software was utilized to conduct a meta-analysis of the outcomes. Results: Seven observational studies consisting of 6,126 patients were included, of whom 1,879 (31%) were ≥80 years old and 4247 (69%) <80 years old. The mean age of the octogenarian and older cohort ranged from 82.3 to 84.5 years, while that of the younger cohort ranged from 68.2 to 75.9 years. The mean follow-up across the studies ranged from one month to five years post-LAAO. Our pooled analysis showed no significant difference in the odds of mortality (OR 1.30; 95% CI [0.49, 3.47]; p = 0.60), all causes of stroke (OR 1.22; 95% CI [0.61, 2.43]; p= 0.57), vascular complications (OR 1.70; 95% CI [0.61,4.73]; p=0.31), and pericardial complications (OR 1.45; 95% CI [0.69, 3.05]; p = 0.33) but a significant difference in the odds of major bleeding events (OR 1.88; 95% CI [1.51, 2.34]; p<0.00001)occurred in patients aged >80 compared to their younger counterparts. Conclusion: This meta-analysis suggests that LAAO in patients aged 80 years and above demonstrates comparable mortality rates, post-procedural complications, and efficacy to those seen in younger patients. The findings support the safety and effectiveness of LAAO as a viable alternative for stroke prevention in very elderly patients, with additional consideration needed for those with increased susceptibility to bleeding events.

Impact of cable lock distribution on firearm securement after emergent mental health evaluation: a randomized controlled trial.

Suicide-related presentations to pediatric emergency departments (PED) have increased in recent years. PED providers have the opportunity to reduce suicide risk by counseling on restricting access to lethal means. Supplementing lethal means counseling (LMC) with safety device distribution is effective in improving home safety practices. Data on PED-based LMC in high-risk patient populations is limited. The objective of this study was to determine if caregivers of children presenting to PED for mental health evaluation were more likely to secure all household firearms if given cable-style gun locks in addition to LMC. In this randomized controlled trial, caregivers completed a survey regarding storage practices of firearms and medication in the home. Participants were randomized to receive LMC (control) or LMC plus 2 cable-style gun locks (intervention). Follow-up survey was distributed 1 month after encounter. Primary outcome was proportion of households reporting all household firearms secured at follow-up. Secondary outcomes included: removal of lethal means from the home, purchase of additional safety devices, use of PED-provided locks (intervention only), and acceptability of PED-based LMC. Two hundred participants were enrolled and randomized. Comparable portions of study groups completed follow-up surveys. Control and intervention arms had similar proportions of households reporting all firearms secured at baseline (89.9% vs. 82.2%, p = 0.209) and follow-up (97.1% vs. 98.5%, p = 0.96), respectively. Other safety behaviors such as removal of firearms (17.6% vs. 11.8%, p = 0.732), removal of medication (19.1% vs. 13.2%, p = 0.361), and purchase of additional safety devices (66.2% vs. 61.8%, p = 0.721) were also alike between the two groups. Both groups held favorable views of PED-based counseling. Within the intervention group, 70% reported use of provided locks. Preference for a different style of securement device was the most cited reason among those not using PED-provided locks. PED-based LMC is a favorably-viewed, effective tool for improving home safety practices in families of high-risk children. Provision of cable-style gun locks did not improve rate of firearm securement compared LMC alone-likely due to high baseline rates of firearm securement and preference for different style of lock among non-utilizers. ID: NCT05568901 . gov. https://clinicaltrials.gov/ . Retrospectively registered October 6, 2022. First participant enrollment: June 28, 2021.

Thermal Analysis of a Simplified Railway Brake Model with Numerical Simulation

The braking system is the most important safety device in all vehicles. When braking, the kinetic energy of the vehicle is converted into thermal energy. The use of friction brakes can cause problems in the long term, as the brake can heat up, reducing its coefficient of friction. Heating and cooling have a harmful effect on all frictional elements, causing material fatigue. As a result of the negative effects, the hot brake cannot reduce the velocity of the vehicle at the correct rate. In this paper, the propagation of frictional heat is analysed in a test specimen made of cast iron material using different numerical simulations. The computational results are validated with the results obtained during measurement. With proper validation, the brake discs are able to be modelled at different designs and materials without having to manufacture a test specimen for each case. In the study, it is important to point physical quantities to carry out the simulation.

Residual Elbow Instability Treated with a Submuscular Internal Joint Stabilizer: Prospective and Consecutive Series with a Minimum Follow-Up of 12 Months

Background: The management of residual elbow instability is a challenging and compelling issue for treating physicians. To overcome inherent drawbacks of dynamic external fixators, the internal joint stabilizer (IJS) has been developed, achieving successful results, but it can sometimes cause local tenderness or anesthetic concerns in the subcutaneous layer. In addition, a bulky anconeus can pull the hardware away from the axis of rotation with an increase in the lever arm and potential issues. To address these issues, an alternative approach has been recently described in which the internal device is covered by the anconeus muscle, becoming submuscular, rather than subcutaneous. The aim of this study was to evaluate the effectiveness of this alternative approach to the IJS application in maintaining a concentric elbow during and after device removal in both acute and chronic scenarios. Methods: Prospective data collection was performed with consecutive patients who had residual elbow instability treated with an IJS (Skeletal Dynamics, Miami, FL) covered by the anconeus from January 2022 and with a minimum follow-up of 12 months. Results: At a medium follow-up of 16 months, the 16 patients selected had a mean arc of flexion–extension of 123° (range: 0–140°) and a mean pronation-supination arc of 150° (range: 80–80°). The mean MEPS and DASH scores were 90.3 ± 6.2 and 6.3 ± 5.3, respectively. At the last follow-up, elbow stability and concentric reduction were confirmed with radiographic and clinical examinations. Conclusions: With a minimum follow-up of 12 months, the present study supports the safety and efficacy of the internal device in a submuscular layer. The clinical outcomes and the rate of recurrent instability are comparable to those achieved with a classic subcutaneous position. Similarly, the complication rate is not affected, and removal surgery is no more aggressive than the classic approach.

Nanoparticle ultrasonication: a promising approach for reducing bacterial biofilm in total joint infection-an in vivo rat model investigation.

While the benefits of sonication for improving periprosthetic joint infection (PJI) are well-documented, its potential therapeutic effect against bacterial biofilm remains unstudied. This study aimed to investigate the safety and efficacy of a novel nanoparticle ultrasonication process on methicillin-resistant Staphylococcus aureus (MRSA) bacterial biofilm formation in a PJI rat model. This novel ultrasonication process was designed to remove attached bacterial biofilm from implant and peri-articular tissues, without damaging native tissues or compromising implant integrity. Twenty-five adult Sprague-Dawley rats underwent a surgical procedure and were colonized with intra-articular MRSA, followed by the insertion of a titanium screw. Three weeks after the index surgery, the animals received a second procedure during which the screws were explanted, and soft tissue was sampled. The intraoperative use of the nanoparticle sonication treatment was employed to assess the device's safety, while ex vivo treatment on the retrieved tissue and implants was used to evaluate its efficacy. Clinical and histological assessments did not indicate any macro- or micro-damage to the host tissue. Sonication of the retrieved tissues demonstrated an average bacterial removal of 2 × 103CFU/mL and 1 × 104CFU/gram of tissue. Compared to the standard-of-care group (n = 10), implants treated with sonication (n = 15) had significantly lower remaining bacteria, as indicated by crystal violet absorbance measurements (P = 0.012). This study suggests that nanoparticle sonication technology can successfully remove attached bacterial biofilms from explanted orthopedic hardware and the joint capsule, without negatively affecting native tissue. The study provides initial results supporting the potential of nanoparticle sonication as an adjuvant treatment option during a DAIR (debridement, antibiotics, and implant retention) procedure for PJI, paving the way for future clinical trials.

Safety and efficacy of an innovative external support device for de novo arterio-venous fistula creation: a French bicentric experience.

The aim of this study was to evaluate the safety and efficacy of VasQTM, a permanent extravascular nitinol vascular support device, implanted around the anastomosis of de novo arteriovenous fistulas (AVF), in consecutive patients. This was a French prospective bicentric study. All patients with an indication for creation of a distal or proximal end to side AVF performed by supervised trainee were eligible. Follow-up was performed clinically and by Duplex scan at 6 weeks and 6 months post fistula creation. Primary endpoint was functional maturation at 6 weeks defined as successful use for dialysis via 2-needle cannulation in dialysis patients or a flow rate of ≥600 mL/min and a target vein diameter ≥6 mm for pre-dialysis patients. Overall functional success for dialysis patients was assessed as well. Between March and November 2022, 21 patients received the VasQTM device and were followed for an average of 165 days. Median age was 61. Eleven patients (52%) were on dialysis at the time of implantation. AVFs were created with distal radial (N.=8), proximal radial (N.=5), brachial cephalic (N.=4) or brachial basilic (N.=4) arteries with 100% technical success . Functional maturation at 6-weeks was achieved in 81% (17/21). Functional success was 80% (12/15) with unassisted functional success of 67% (10/15) at 6 months for patients requiring dialysis at that time point. Two reoperations were performed within the device, one thrombectomy and one angioplasty, both were successful. Freedom from access-related interventions occurred in 71% (15/21) of the study population at 6-months. This study demonstrates that the VasQTM AVFs achieved high rates of maturation at 6-weeks, without the need to modify standards of care. VasQTM can successfully assist in achieving excellent results at the introduction of the device to a new center.

Investigating the Catastrophic Roof Failure of a Fatty Acid Storage Tank: Causes, Mechanisms, and Safety Implications

This paper investigates the catastrophic failure of the roof weld on a carbon steel storage tank at a Fatty Acids plant, which was attributed to pressure overload. The incident resulted in the tank's roof, weighing over 5 tons and spanning 8 meters in diameter, being propelled 25 meters from the tank. Despite installing several safety devices, including pressure regulating valves, pressure indicator controls, and pressure vacuum relief valves, inadequate maintenance led to their malfunction. This study examines the mechanisms and causes behind the failure, highlighting the crucial role of regular maintenance in ensuring the functionality of safety instruments. While neither toxic nor flammable, the plant's compressed air system poses a significant hazard due to the energy stored at slight overpressure, necessitating vigilant management by the safety department. The findings underscore the importance of robust maintenance strategies and procedural adherence to prevent similar incidents, enhancing industrial storage systems' overall safety and reliability.

Numerical simulations on non-reactive multiphase flow during the transition from vent activation to venting with vent cap fragments in 18650 lithium-ion batteries

Mandatory safety devices, prevalent in lithium-ion batteries (LIBs), enable current interrupt device (CID)-and vent-activated power-off protection by sensing the electrochemical gas production boost triggered by thermal runaway (TR). For an in-depth understanding of the early warning of safety devices, the thermodynamic and multiphase flow behaviour of gases-vent particles interaction under the non-combustion venting phase is numerically investigated. From the gas phase simulation results, the flow field structure of the counter-rotating vortex pairs (CVPs) bounded by vent cap fragments enhances the heat transfer between ambient air and the venting gas, and the local venting gas temperature can reach a drop of >100 K. The transient three-dimensional spatial evolution characteristics of vent particles interacting with vent cap fragments at the early stage of the venting process after 18650 thermal runaway-induced vent-activation is originally demonstrated, including gas temperature and velocity as well as particle size and temperature. The spatial distributions of polydisperse particle size and temperature under the process of non-combustion venting are used to characterize the ejected particles' behaviour, which reveals the particle trajectories in particle-laden streams and their heat-transfer characteristics. The results show that ejected particles with relatively high temperatures and large sizes are mainly clustered within the cell diameters, and possible thermal runaway propagation inside the module can be triggered by the smaller-size particles of higher temperature sprayed in the periphery when the blocking effect of the vent cap fragment is weakened.

Dual layer-coating of PDMS to prevent calcification and bacterial infection for the potential use of urinary tract biomaterials

Polydimethylsiloxane (PDMS) is widely used in medical devices because of its exceptional properties. However, challenges, such as biofouling and bacterial infections, arise from their hydrophobic nature, especially in devices intended for the urinary tract. To address these issues, this study pioneered a surface modification strategy aimed at enriching PDMS with both hydrophilicity and antifouling attributes, making it ideal for urinary tract device applications. We introduced a novel dual-layer coating process, initially grafting a hydrogel-like poly(acrylic acid) (PAA) layer onto PDMS through benzophenone-mediated photoinitiated polymerization to enhance surface hydrophilicity. Subsequently, polyethyleneimine (PEI) was covalently bonded to the PAA layer, ensuring the formation of a stable antifouling surface that prevented bacterial adhesion and calcium deposition. This method guarantees a robust coating that performs consistently across various environmental conditions, including the fluctuating pH levels typical of the urinary tract. Comprehensive surface characterization validated the substantial improvements in hydrophilicity along with significant reductions in bacterial adhesion and calcium deposition. The innovative PAA/PEI dual-layer coating demonstrated marked superiority over conventional uncoated and single-layer-coated PDMS samples, offering a promising solution for enhancing the safety and efficacy of PDMS-based urinary tract devices. The implications of this study extend beyond immediate applications and provide valuable insights into the domains of biomaterials and medical device engineering.

Food and Drug Administration Database Secondary Analysis: Difference in Operative Hysteroscopy Device Safety Profiles

Food and Drug Administration Database Secondary Analysis: Difference in Operative Hysteroscopy Device Safety Profiles

Current Trends in the Treatment of Pediatric Hydrocephalus: A Narrative Review Centered on the Indications, Safety, Efficacy, and Long-Term Outcomes of Available Treatment Modalities

The pathophysiologic substrate of pediatric hydrocephalus has not been thoroughly elucidated. Valve-based shunt systems have constituted the main therapeutic option since the late 1950s. The initially used systems were concerning the ventricular system and the atrium. In the 1970s, VA shunts were not the main stay of treatment as the preferred option for the terminal end of the drainage system was the peritoneum. Our review analyzes these valve types and attempts a comparison, based on their functional characteristics. Nowadays, the only available surgical alternative for the treatment of hydrocephalus is ETV. This technique is associated with lower infection rates as well as, on average, a lower re-operation rate. Another term that deserves special mention is related to the outcome of ETV in children who had a medical history of previously incorporated shunts and who were subsequently suffering from shunt malfunction. Well-recognized predictive factors associated with secondary ETV failure include age, early onset of hydrocephalus, and prematurity. Although several attempts have been made in order to establish the optimum surgical treatment management in the different subgroups of patientswho are suffering from shunt dysfunction, there is no universal agreement. Therefore, this review attempts to identify the specific subpopulations of patients in whom the insertion of a drainage system as the preferred treatment modality is associated with an optimum long-term prognosis, compared to ETV, and vice versa. The objective of our study is to analyze the safety, efficacy, and outcomes of drainage devices and ETV in pediatric hydrocephalus patients.

Successful pilot implementation of mailing lethal means safety devices to veterans calling the Veterans Crisis Line.

Veterans are at greater risk for suicide than non-veterans; veterans who call the Veterans Crisis Line are at even higher risk. Firearms and poisoning are among the most common methods by which people die by suicide in the United States and access to those lethal means are risk factors for suicide. The United States Department of Veterans Affairs' Veterans Crisis Line conducted a six-month pilot to enhance lethal means safety counseling conversations by mailing lethal means safety devices (cable gun locks and/or medication takeback envelopes) to veteran callers. Veterans Crisis Line responders were selected based on quality assurance ratings, received training, and passed a knowledge check prior to participating. Veterans were eligible if they were calling for themselves and had access to firearms and/or surplus medications. The pilot was assessed using operational data and qualitative interviews with responders to assess their experience, barriers and facilitators, and suggestions for improvement. Responders documented 8,323 calls from 7,005 unique phone numbers; 10.8% were eligible for cable gun locks and 8.7% were eligible for medication takeback envelopes. Responders offered cable gun locks to 652 veterans and medication takeback envelopes to 522 veterans. A total of 465 cable gun locks and 567 medication takeback envelopes were mailed to 307 veterans. Operationally, there was little impact of the pilot on call handle time. Five responders participated in qualitative interviews. They reported feeling comfortable incorporating mailing devices into their work and reported that response from veterans was positive. Their most frequent suggestion for improvement was additional training. Results demonstrate that mailing these devices to veterans was feasible and acceptable. Call handle time results show that the Veterans Crisis Line would not need additional personnel to manage changes in call handle time associated with offering devices to all veteran callers. Full implementation of this program will require updates to procedures and policies, training, documentation system changes, additional logistical support for mailing, and a plan for ongoing evaluation.

A machine learning framework to adjust for learning effects in medical device safety evaluation.

Traditional methods for medical device post-market surveillance often fail to accurately account for operator learning effects, leading to biased assessments of device safety. These methods struggle with non-linearity, complex learning curves, and time-varying covariates, such as physician experience. To address these limitations, we sought to develop a machine learning (ML) framework to detect and adjust for operator learning effects. A gradient-boosted decision tree ML method was used to analyze synthetic datasets that replicate the complexity of clinical scenarios involving high-risk medical devices. We designed this process to detect learning effects using a risk-adjusted cumulative sum method, quantify the excess adverse event rate attributable to operator inexperience, and adjust for these alongside patient factors in evaluating device safety signals. To maintain integrity, we employed blinding between data generation and analysis teams. Synthetic data used underlying distributions and patient feature correlations based on clinical data from the Department of Veterans Affairs between 2005 and 2012. We generated 2494 synthetic datasets with widely varying characteristics including number of patient features, operators and institutions, and the operator learning form. Each dataset contained a hypothetical study device, Device B, and a reference device, Device A. We evaluated accuracy in identifying learning effects and identifying and estimating the strength of the device safety signal. Our approach also evaluated different clinically relevant thresholds for safety signal detection. Our framework accurately identified the presence or absence of learning effects in 93.6% of datasets and correctly determined device safety signals in 93.4% of cases. The estimated device odds ratios' 95% confidence intervals were accurately aligned with the specified ratios in 94.7% of datasets. In contrast, a comparative model excluding operator learning effects significantly underperformed in detecting device signals and in accuracy. Notably, our framework achieved 100% specificity for clinically relevant safety signal thresholds, although sensitivity varied with the threshold applied. A machine learning framework, tailored for the complexities of post-market device evaluation, may provide superior performance compared to standard parametric techniques when operator learning is present. Demonstrating the capacity of ML to overcome complex evaluative challenges, our framework addresses the limitations of traditional statistical methods in current post-market surveillance processes. By offering a reliable means to detect and adjust for learning effects, it may significantly improve medical device safety evaluation.

12-month Safety and Efficacy Outcomes of a Standalone Trabecular Bypass Device

12-month Safety and Efficacy Outcomes of a Standalone Trabecular Bypass Device

Efficacy and safety of the Aria pulmonary endovascular device in pulmonary hypertension

Abstract Background and aims A common feature of various forms of pulmonary hypertension (PH) is progressive decline of pulmonary arterial compliance (CPA), which correlates with reduced survival. In this acute study, we evaluated feasibility, safety and hemodynamic performance of the Aria pulmonary endovascular device in patients with PH associated with left heart disease (PH-LHD) and chronic lung disease (PH-CLD). Methods 8 patients with PH-LHD and 10 patients with PH-CLD were included in this study. The device was placed in the main pulmonary artery via the right femoral vein and was connected by a catheter to a gas-filled reservoir outside the body. During systole, gas shifts from the balloon to the reservoir, leading to deflation of the balloon. In diastole, the gas returns from the reservoir to the balloon, leading to balloon inflation and enhancing diastolic blood flow to the distal pulmonary capillary bed. Hemodynamics were assessed at baseline, and again with device off, device on and device off. The primary safety endpoint was the incidence of serious adverse events through 30 days after the procedure. Results No complications or investigational device-related serious adverse events occurred. Device activation in PH-LHD and PH-CLD patients decreased pulmonary arterial pulse pressure by 5.6±4.2mmHg (-12%; p=0.003) and 4.2±2.2mmHg (-11%; p<0.001), increased CPA by 0.4±0.2mL/mmHg (+23%; p=0.004) and 0.4±0.3mL/mmHg (+25%; p=0.001), and increased RV-PV coupling by 0.24±0.18 (+40%; p=0.012) and 0.11±0.07 (+21%; p=0.001), respectively. Conclusions Temporary implantation of the Aria endovascular device was feasible and safe. Device activation resulted in acute improvement of CPA and RV-PV coupling.Figure

One-year results from the REDUCER-I multi-center real-world clinical trial of the treatment of refractory angina with the coronary sinus Reducer

Abstract Background/Introduction Patients with refractory angina have chronic symptoms due to reversible ischemia which are inadequately controlled with optimal medical therapy or interventional treatments. These patients suffer from a poor quality of life and place a significant strain on the health care system due to their frequent rehospitalizations. The coronary sinus (CS) Reducer is a stainless-steel hour-glass shaped mesh stent that creates a focal narrowing in the lumen of the CS resulting in improved microvascular resistance and redistribution of myocardial blood flow. Purpose The COSIRA randomized controlled trial showed the Reducer is a safe and effective treatment for refractory angina with patients having significant improvements in Canadian Cardiovascular Society (CCS) class and other measures of quality of life. The REDUCER-I post-market study evaluated the long-term outcomes with the Reducer in a large and challenging ‘real-world’ cohort. Methods REDUCER-I is a multicenter, non-randomized study conducted across 26 medical centers in Europe. At one year, device effectiveness was assessed by improvement in CCS grade as compared to baseline and device safety was assessed by Major Adverse Cardiac Events (MACE). Secondary endpoints included six-minute walk tests, EQ-5D-5L tests, and Seattle Angina Questionnaires (SAQ). Subjects were followed at 30 days, 6 months, and annually through five years. Results The as-treated population includes a total of 371 patients who received a Reducer implant (78.7% (292/371) male, 47.2% (175/371) diabetic, 73.9% (274/371) post-revascularization). The one-year Kaplan-Meier overall MACE rate post-implant was 7.1% (95% CI [4.9, 10.4]). There were nine deaths within the first 365 days, one death was due to unknown causes and eight deaths were adjudicated to as not being device- or procedure-related. At 12 months, 70.0% (205/293) of patients improved by ≥1 CCS class. At baseline, 72.2% (232/363) of patients were CCS class III/IV and this proportion decreased to 18.1% (54/298) at 12 months (P<0.0001). The patients’ baseline six-minute walk distance was 327.5±116.1m which improved by a mean of 30.8±81.8m at 12 months (p<.0001). In the year prior to Reducer implant, 33.3% (88/264) of the patients had at least one visit to the emergency department compared to 11.7% (31/264) in the year after Reducer implant (p<.0001). The significant improvements in CCS class and SAQ-QoL were sustained through 3 years (Figure). Conclusion In this 12-month analysis of the REDUCER-I study, patients with refractory angina treated with the CS Reducer had low MACE rates and showed significant and sustained improvements in angina, QoL, functional capacity, and need for rehospitalization.

Development of a Medical Device Lifecycle Research Database at the MFDS

Abstract So-called big data are potentially useful in the healthcare field and are of interest to researchers, industry, and government agencies. Over the past 10 years, Europe, the United States, and Asia have been making efforts to collect and systematically manage information on the entire process from clinical trials to follow-up management of medical devices (MD). We developed MD lifecycle research database at the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea, consisting of 61 tables and 2,053 variables. The MFDS possesses statistical information on all MD, pharmaceuticals, foods, and human tissues produced and distributed. The information in the database is categorized according to four MD lifecycle phases-clinical trial, approval, production, and post-approval. For the clinical trial phase, the database contains information on planning and approval of clinical trial and non-clinical trial. The approval phase includes information on models, raw materials, quality, and changes, while the production phase stores information on production, import, export, supply and use. For the last step, follow-up management phase, provide information on post-marketing safety management, risk management, and administrative disposition. All four steps are linked based on primary key, so it is possible to understand information on the overall MD lifecycle. The MD Lifecycle Research Database will help strengthen the industry’s competitiveness in terms of cost-effectiveness in MD development and facilitate policy monitoring by improving its utilization in the public interest. This database contains information on all MD produced and distributed in Korea depending on the phases of the MD lifecycle, and data is easily accessible due to the lack risk of personal information exposure, so it can be widely used by individual researchers, industries, academia, and governments. Funding This research was supported by a grant (22063MFDS498) from ministry of food and drug safety in 2024. Key messages • We developed a medical device lifecycle database that enables tracking management according to the medical device lifecycle. • This database can be used as a scientific basis to ensure the safety, effectiveness, and efficiency of medical devices.