Expert review of medical devices最新文献

Objectives: Chemotherapy, while effective, can damage blood vessels due to repeated punctures and drug irritants, leading to complications like tissue damage from infiltration, clots, and phlebitis. To reduce these risks and improve patient comfort, venous catheters such as centrally inserted access ports (PORTs) and peripherally inserted central catheters (PICCs) are commonly used.

Methods: This study systematically reviewed and analyzed clinical and economic data comparing PORTs and PICCs in adult chemotherapy patients, considering randomized trials, observational studies, and cost-effectiveness analyses. Data on complications and costs were extracted, and meta-analyses were conducted. Risk of bias was also assessed.

Results: Sixty-three studies were included. PORTs showed significantly lower rates (per 1000 catheter-days) of thrombosis, local infections, and catheter malposition compared to PICCs. Similar trends were seen for wound complications and mechanical issues. Economic analyses favored PORTs for cost-effectiveness. Study limitations included heterogeneity and potential bias, though overall quality was moderate to good.

Conclusion: Findings support the clinical and economic value of PORTs for long-term chemotherapy, difficult venous access, and low-maintenance needs, whereas PICCs suit shorter treatment durations, patients unsuitable for minor surgery, or settings favoring bedside insertion. Decisions should align with the goals of the European Health Technology Assessment Regulation to harmonize medical device evaluation across Europe.

Introduction: The number of individuals aged 50 years or older at risk of an osteoporotic fracture was 158 million worldwide in 2010, a number projected to double by 2040. Optimization of fracture fixation techniques for osteoporotic and pathologic fractures and developing novel implants addressing growing demand are paramount.

Areas covered: This manuscript details clinical applications of the IlluminOss Photodynamic Bone Stabilization System (PBSS), surgical techniques, the novelty of the device, and highlights early clinical results.

Expert opinion: The IlluminOss PBSS represents a new implant category in fracture fixation with broad applications. The system's intraoperative flexibility permits insertion with minimal soft tissue damage, enhancing wound healing and recovery - particularly advantageous for oncology patients requiring adjuvant chemotherapy. The implant provides non-traditional access points, expanding indications for intramedullary fixation. The PBSS can provide stand-alone fixation or augment traditional plate-and-screw constructs. The balloon's conformity to curved trajectories provides creative alternatives to pelvic fixation and can support complex acetabular arthroplasty. The PBSS can help prevent allograft fractures and has applications in limb lengthening/deformity correction. Early clinical data show high procedural success, significant pain reduction, and improved function comparable to standard fixation. Future work will assess its use in contaminated fractures or osteomyelitis, due to blue light's potential antimicrobial effects.

Background: Meniscal tears concurrent with anterior cruciate ligament tears affect patients' mobility and quality of life. This study sought to evaluate the meniscal-related reoperation rate by meniscal device.

Methods: A retrospective, comparative study design was conducted. Using the New Zealand ACL Registry two device groups were identified, patients the received TRUESPAN™ (DePuy Synthes, Raynham MA) (Device A) and patients that received one of two unspecified branded devices (Device B or C). The rate of meniscal-related reoperation was estimated. Cox proportional hazard models were run to compare rates.

Results: Device A group had 1332 patients and Device B/C group had 3105 patients. Device A had a similar reoperation rate as Device B (0.041 versus 0.03 cases/100 person-years, p-value = 0.275) and a statistically significantly lower rate than Device C and B/C (0.131 and 0.125 cases/100 person-years, p <0.001 for both). This trend was similar across age, gender and graft type subgroups. Compared to Device A, Device C and Device B/C had higher reoperation risks (hazard ratio, p-value: 3.995, <0.001; 3.623, <0.001) and Device B had no significantly different risks (0.509, 0.269).

Conclusion: Compared to Device A, meniscal reoperation rates were significantly higher in Device C and not significantly different to Device B.

Introduction: Obstructive sleep apnea (OSA) is a prevalent sleep disorder associated with serious health consequences and major economic burdens. Current diagnosis and treatment approaches are insufficient for the growing global burden of OSA. Novel device-led technologies may enable more efficient and personalized OSA management.

Areas covered: This review explores the potential role of screening tools such as regulatory-cleared wearables and discusses recent advancements in simplified home sleep testing and automated scoring software. Current and emerging OSA treatment monitoring systems, treatment optimization approaches, and therapy guidance tools are explored. Finally, we highlight the role of cloud-based platforms, telehealth, and AI-driven applications in enabling long-term monitoring and precision medicine approaches.

Expert opinion: Novel OSA-related devices are enhancing clinical practice by improving access, adherence, and therapy outcomes. Patients and clinicians are encouraged to embrace the technology with caution. Challenges remain in the accuracy of diagnostic and treatment devices, ensuring data privacy, and integrating these tools into clinical practice. Regulatory bodies must advocate for independent clinical trial validation standards, algorithmic transparency, and education on novel devices for patients and clinicians, to ensure safe implementation. With continued innovation, validation, and adoption, device-led care may become central to the proactive and patient-centered future of OSA management.

Background: A new health monitoring device called Fitbit Charge 6 has appeared on the Vietnamese market. This study aimed to evaluate the consistency between Fitbit Charge 6 and structured interview questions in measuring sleep quality among breastfeeding mothers.

Research design and methods: A cross-sectional study utilizing random convenience sampling was conducted in Ho Chi Minh City, Vietnam, involving 208 breastfeeding women one month postpartum. The participants used the Fitbit Charge 6 device continuously for four days and three nights to gather daily sleep information; then, they were administered a structured sleep questionnaire via home interviews.

Results: The correlation between the total sleep time (TST) recorded by both the device and interview was weak (r = 0.28), as was the correlation for short nap duration (r = 0.25). The agreement between the Fitbit Sleep Score and sleep satisfaction from the questionnaire was 79.9%, with a notably low kappa coefficient (0.02), indicating a lack of strong agreement.

Conclusion: The Fitbit Charge 6 did not show reliable correlation with the subjective sleep data reported by one-month postpartum breastfeeding women. Further research employing rigorous comparative studies is necessary to assess the validity and reliability of sleep data collection methods for this demographic.

Introduction: Percutaneous left atrial appendage closure (LAAC) is an increasingly relevant strategy for stroke prevention in patients with non-valvular atrial fibrillation (AF) who are ineligible for long-term oral anticoagulation. Its clinical relevance continues to expand as device technology and operator experience evolve.

Areas covered: This review provides an updated synthesis of currently available LAAC devices - including contemporary and emerging technologies - and summarizes comparative evidence from major trials and registries. A structured literature search was performed in PubMed, Scopus, and Web of Science. Additional focus is dedicated to expanding clinical applications, including use in chronic kidney disease, persistent left atrial appendage thrombus, stroke despite anticoagulation, and combined procedures such as LAAC with atrial fibrillation ablation.

Expert opinion: LAAC is entering a new phase in which its role may broaden beyond traditional indications, driven by improved safety, individualized antithrombotic strategies, and promising innovations such as dual‑seal and exclusion‑based devices. Future research will determine whether LAAC can transition from a selective therapy into a mainstream option for stroke prevention.

Introduction: Urinary incontinence (UI) is a common and often debilitating condition affecting a significant portion of adult women, with a substantial physical, psychosocial, and quality of life impacts. Pelvic floor muscle therapy (PFMT) is a first-line, noninvasive treatment for UI; however, technological innovations are offering new approaches to enhance treatment adherence and outcomes. This review compares two devices - Innovo, a neuromuscular electrical stimulation wearable garment (NMESWG), and Leva, an intravaginal sensor-based system (IVSBS) in the management of UI.

Areas covered: The NMESWG device, FDA-cleared for stress UI, provides external electrical stimulation, showing mixed clinical efficacy in trials, with promising pad weight reductions but limited sample sizes. In contrast, IVSBS uses accelerometer-based feedback via a mobile app and has shown superior outcomes, including significant reductions in symptom severity, improved pelvic floor function, and long-term symptom relief. IVSBS also demonstrated higher patient adherence, with better patient-reported outcomes.Both devices are safe and well tolerated, with IVSBS benefitting from a more robust base of clinical evidence and patient engagement data than the NMESWG has.

Expert opinion: At-home UI therapies may expand access to care for motivated, technologically literate individuals, with sufficient evidence to support IVSBS use.

Introduction: Hypertension is a major global health burden and a leading contributor to cardiovascular morbidity and mortality. Recent advances in digital technology - including home blood pressure (BP), telemonitoring, mobile health applications, wearable devices, and clinical decision support systems - have opened new avenues for improving hypertension management by addressing limitations such as clinical inertia, poor medication adherence, and lack of individualized care. These tools support patient engagement, facilitate behavioral change, and enable remote treatment optimization.

Areas covered: This review summarizes the current evidence supporting digital interventions for BP control, highlighting findings from recent randomized controlled trials and meta-analyses via PubMed (2000-2025). Evidence indicates that digital strategies have demonstrated significant reductions in systolic BP compared with usual care, with benefits observed across diverse populations and settings. Digital health approaches have also been shown to enhance medication adherence, promote lifestyle modifications, and offer cost-effective alternatives to conventional care. Moreover, their utility during disasters and pandemics underscores their value in ensuring continuity of care.

Expert opinion: While challenges remain, including integration into clinical workflows, regulatory considerations, and disparities in access - efforts to validate, standardize, and scale digital solutions will be critical to their successful implementation in routine care.

Introduction: Regenerative Peripheral Nerve Interface (RPNI) surgery represents a biologic solution to three major challenges in amputation care: (1) achieving intuitive, high-fidelity prosthetic control, (2) mitigating post-amputation pain, and (3) enabling meaningful sensory feedback. By using denervated autologous tissue as a physiologic target for regenerating axons, RPNI surgery is a promising strategy that permits closed-loop control of prosthetic devices.

Areas covered: This review focuses on unanswered questions and emerging opportunities regarding RPNI surgery. We examine three key areas: (1) determining the optimal number of RPNIs, (2) selecting the most appropriate graft tissue type, and (3) leveraging novel RPNI variations to expand clinical impact. To explore these topics, we synthesize preclinical and clinical evidence by systematically searching PubMed/MEDLINE, Embase, and Scopus for studies related to RPNI from inception to date. We aim to identify research priorities that will accelerate the evolution of RPNI surgery to revolutionize neuroprosthetic rehabilitation.

Expert opinion: RPNI surgery has evolved from proof-of-concept to a feasible, scalable strategy for treating patients with amputations. Future progress will depend on refining patient- and nerve-specific modifications, developing wireless, bidirectional devices that leverage RPNI signal transduction, and addressing reimbursement and training barriers. With continued interdisciplinary collaboration, RPNI surgery is poised to become a critical component of prosthetic rehabilitation.