Expert review of medical devices最新文献

Introduction: The transfusion of blood and blood components is essential for the resuscitation of patients with critical bleeding. These fragile biological therapeutics demand specialized devices for procurement, processing, transport, storage, and transfusion.

Areas covered: We discuss some of the challenges and solutions to the often-overlooked phases of transport and storage of blood and blood components.

Expert opinion: Strict maintenance of temperatures is required to ensure the efficacy and safety of blood components. This can be achieved using active or passive transport systems, known as shippers. Additional storage and transportation considerations include pre-conditioning of cold or frozen bricks, packing construct of protective insulating material, location of blood components in shipper, and labeling of blood transport shippers. Blood components are usually collected and stored in polyvinyl chloride bags. Historically, plasticizers such as di-(2-ethylhexyl) phthalate (DEHP) were added to preserve the quality of the product, but regulatory bans have led blood services to explore alternative plasticizers. Newer, dried blood components require innovative storage solutions currently ranging from glass containers to plastic bags that are modified to minimize degradation from light and moisture. Innovation in blood components demands innovation in devices for collection and storage, with oversight by accredited bodies for quality assurance.

Introduction: Sacroiliac joint (SIJ) dysfunction accounts for up to 30% of axial low back pain and is increasingly managed surgically after failure of conservative care. While traditional open SIJ fusion carried significant morbidity, minimally invasive (MIS) approaches have transformed outcomes. More recently, stereotactic navigation and robotic assistance have emerged to enhance implant placement accuracy and reduce radiation exposure.

Areas covered: We conducted a narrative review of the literature (PubMed, EMBASE, Cochrane Reviews, inception) on SIJ fusion techniques, implant accuracy, complications, fusion rates, and patient-reported outcomes. MIS SIJ fusion now predominates over open approaches, with lateral and posterior techniques both achieving >90% fusion at 12-18 months. Navigation and robotic systems achieve 92-98% implant accuracy (vs. 76-87% with fluoroscopy) and reduce intraoperative radiation exposure by up to 85%, especially in anatomically complex or revision cases.

Expert opinion: Navigated and robotic-assisted SIJ fusion represents significant technical progress. While short-term clinical outcomes remain comparable to fluoroscopic MIS fusion, navigation, and robotics improve safety, reproducibility, and radiation safety. Future multicenter trials should assess long-term outcomes, cost-effectiveness, and integration of augmented reality, AI, and novel implants to define their optimal role in sacroiliac joint surgery.

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: 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.

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 the accessibility.

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. Further research into modular prefabrication and functional dynamization shows promise but requires robust clinical trials to establish safety and cost-effectiveness. Hybrid strategies that combine prefabrication with selective customization appear more realistic than fully custom made devices. Over the next decade, immobilization devices are likely to evolve into sensor-enabled, modular systems offering improved comfort and function, albeit with trade-offs in cost, complexity, and regulatory demands.

Background: Tricuspid regurgitation (TR) adversely impacts mortality and hospitalizations. Transvenous pacemaker and defibrillator leads are associated with worsening TR, underscoring the need for lead designs that minimize adverse tricuspid valve interference.

Method: We developed a physics-based computational model to evaluate the general effect of lead diameter and material stiffness on the regurgitant orifice area (ROA). Additionally, we simulated three commercial transvenous leads, with diameters of 4.7 Fr, 6.8 Fr and 8.6 Fr, and evaluated the induced ROA. Three pre-implant baseline conditions were considered in all cases: no TR, mild TR and moderate TR.

Results: Lead diameter exhibited a predominant effect on ROA compared to material properties. In mild and moderate TR baselines, thicker leads resulted in exponential increases in ROA. The 4.7 Fr lead remained significantly below clinically relevant increases in TR. In contrast, the 6.8 Fr and 8.6 Fr leads induced a transition from mild to moderate TR.

Conclusions: Simulations support the mechanistic expectation that thinner defibrillation leads reduce mechanical interference with tricuspid leaflet coaptation, with potential implications on clinical outcomes.

Introduction: The SynCardia Total Artificial Heart (TAH) offers a life-saving mechanical circulatory support (MCS) option for patients with end-stage biventricular (BiV) heart failure who are not candidates for traditional devices or are awaiting transplantation. The device and its prior success has opened doors to further research in newer devices and technologies to combat existing challenges with TAH.

Areas covered: This review highlights the clinical utility, device profile and function, safety considerations, patient selection, and current challenges associated with the device. It summarizes key clinical studies, FDA approval history, technical specifications of the TAH, outcomes, complications, and logistical considerations. Literature was sourced through PubMed and clinical trial databases using terms such as 'SynCardia,' 'total artificial heart,' 'biventricular failure,' and 'bridge to transplant.'

Expert opinion: TAH offers full heart replacement and is evolving toward becoming a long-term alternative to transplants. Challenges like power supply, long-term durability, and biocompatibility are being addressed through innovations such as fully implantable systems and hybrid biological-mechanical designs. Unlike transplantation, TAHs avoid immunosuppression and offer hope to patients who cannot wait for donor hearts.In the coming years, global development of advanced TAHs, coupled with better clinical acceptance could transform treatment of end-stage heart failure providing a more accessible, reliable, and life-sustaining solution.

Background: Early Feasibility Studies (EFS) support early-stage evaluation of novel technologies. Under the European Union Medical Device Regulation (EU MDR 2017/745), National Competent Authorities (NCAs) assess these investigations. However, little is known about their organizational readiness and ability to assess complex technologies in a consistent and coordinated manner.

Research design and methods: A mixed-methods study was conducted via an online survey and virtual workshop involving 23 NCAs. Outcome measures included assessor assignment models, qualifications, training, use of external experts, sponsor dialogue mechanisms, and preparedness for emerging technologies. Data were thematically analyzed to assess systemic readiness and capacity.

Results: There is variability in the documentation of clinical investigation phases and assessment practices. Gaps in NCA resources were notable in digital health technology (DHTs) and artificial intelligence-enabled medical devices (AIeMD) and statistics. Dialogue mechanisms were present in 63% of NCAs and associated with improved submission quality. Training was fragmented and use of external experts limited. NCAs emphasized regulatory strain due to rising complexity.

Conclusions: There is significant variability in assessor qualifications and practices. These differences limit the consistency of regulatory oversight under the MDR. Establishing structured training programs, and harmonized sponsor dialogue mechanisms will be critical to supporting regulatory preparedness and coherence.

Introduction: Infective endocarditis (IE) is a serious and increasingly recognized condition, associated with significant morbidity and mortality. The diagnosis of IE is more challenging in patients with implanted cardiac devices such as cardiac implantable electronic devices, left ventricular assist devices, and left atrial appendage occlusion devices.

Areas covered: This review focuses on the contemporary roles and applications of multi-modality imaging in the evaluation of patients with cardiac implantable electronic devices related infection and IE. The role of multi-modality imaging in the diagnosis of patients with native or prosthetic valve IE is beyond the scope of this review. A literature search of the PubMed database was performed between 1 June 2024, and 30 June 2025. Relevant articles on the subjects of 'infective endocarditis,' 'multi-modality imaging,' and 'implanted cardiac devices' were utilized in our review.

Expert opinion: The growing utilization of cardiac implanted electronic devices (CIED) demands improvement in the detection of CIED-related infections. Contemporary guidelines have considered utilizing multimodality imaging to diagnose IE. The incremental value of multimodality imaging remains to be rigorously examined. Large observational studies from tertiary centers might serve as the starting point toward building a strong evidence base.