Expert review of medical devices最新文献

Introduction: Endoscopic ultrasound (EUS) has emerged as a cornerstone in gastrointestinal diagnostics and therapeutics worldwide. In Saudi Arabia, however, its development has not yet been comprehensively reviewed in the context of evolving clinical practice and training needs.

Areas covered: This narrative review synthesises published literature between 2000 and April 2025 to map the progression of EUS practice in Saudi Arabia. A systematic search of PubMed, Scopus, Google Scholar, and regional academic repositories was performed. Inclusion criteria targeted studies reporting on diagnostic or therapeutic EUS performed in Saudi healthcare institutions. Nine relevant publications were identified, including original research, case series, and survey-based data. Early studies highlighted EUS's role in diagnosing pancreatic lesions, choledocholithiasis, and subepithelial tumors. More recent reports demonstrated therapeutic advances such as biliary drainage, liver abscess management, and EUS-guided liver biopsy. One multinational survey provided insight into local training infrastructure gaps and simulator access.

Expert opinion: EUS in Saudi Arabia is transitioning from a specialized diagnostic modality to a broader interventional platform. To fully realize its potential, coordinated efforts in workforce training, national procedural registries, and multicentre collaboration will be essential to standardize access and quality across the Kingdom.

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.

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: 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: Bone fractures represent a global health problem with the incidence of fractures on the rise each year. The predominant method for addressing bone fractures involves immobilization. Worldwide, many initiatives have sought to develop innovative fracture immobilization designs, and numerous solutions have been patented. However, a comprehensive overview and systematic classification of these patented designs is lacking.

Areas covered: In pursuit of these patented immobilization designs, the Espacenet database, recognized as the largest global repository of patents, served as the principal investigative tool. Using a search string, patent classifications and inclusion criteria a total of 71 patents were identified. These can be classified into four unique design groups: (1) fixed and partly enclosed, (2) fixed and fully enclosed, (3) adjustable and partly enclosed and (4) adjustable and fully enclosed designs. The designs that are commercially available are predominantly situated within groups 3 and 4.

Expert opinion: Advances in 3D scanning and additive manufacturing could improve comfort, personalization, and monitoring in fracture immobilization, but clinical adoption is hindered by slow production times, workflow misalignment, and regulatory barriers. Key improvements are needed in scanning accuracy, adjustment protocols, and integration into hospital logistics to ensure both technical feasibility and clinical usability..

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: Transcatheter aortic valve replacement (TAVR) has transformed treatment of severe aortic stenosis, offering a less invasive alternative to surgery. Despite advances, stroke remains a serious complication, impacting morbidity, mortality, and long-term cognitive function, thus the need for effective prevention strategies.

Areas covered: Based on a targeted review of the PubMed literature, this review addresses mechanisms and risk factors for stroke after TAVR and evaluates current preventive approaches. Cerebral embolic protection devices (CEPDs), particularly the Sentinel system, are discussed alongside other devices. Antithrombotic strategies before, during, and after TAVR are also reviewed, emphasizing the balance between thromboembolic protection and bleeding risk in an elderly population.

Expert opinion: While some studies suggest CEPDs may reduce stroke, randomized trials have not confirmed broad and robust benefit, and high cost limits routine adoption. Future work should focus on high-risk subgroups, device refinement, and large-scale trials. For now, individualized antithrombotic therapy and selective CEPD use remain central to stroke prevention in TAVR.

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: Temporary mechanical circulatory support (tMCS) has become essential in managing severe cardiac dysfunction, particularly refractory cardiogenic shock (CS). Despite widespread adoption, the optimal use of tMCS is often guided by institutional experience rather than robust evidence, leaving questions about device selection and patient outcomes.

Areas covered: We conducted a structured literature review of studies published in major databases (PubMed), using keywords such as intra-aortic balloon pump, veno-arterial extracorporeal membrane oxygenation, percutaneous ventricular assist devices, cardiogenic shock, and related terms. Key clinical scenarios reviewed include acute myocardial infarction-related CS, post-cardiotomy shock, and support for high-risk percutaneous coronary interventions. We critically examine randomized controlled trials, extensive observational studies, and consensus statements published in the last five years.

Expert opinion: While tMCS has revolutionized the management of CS, its optimal use is still limited by a lack of high-quality evidence, ongoing device-related complications, and economic challenges. Future advancements in device technology, patient stratification, and standardized protocols, alongside continued research and innovation, are essential to improve outcomes and broaden accessibility.