Expert review of medical devices最新文献

Introduction: Oral appliance therapy (OAT) for obstructive sleep apnea (OSA) is a complex and dynamic intervention that requires efficient tools to evaluate treatment response and monitor therapeutic outcomes.

Area covered: This review aims to provide a structured overview of current techniques for OAT monitoring, with a particular focus on mandibular jaw movement (MJM) analysis - a promising yet underutilized approach. Literature searches were conducted in PubMed, Scopus, and the Cochrane Library databases up to February 2025. Fifty-six studies were examined, encompassing morphometric and physiological measurements applied at different stages of OAT management in OSA patients. A wide range of measurement techniques were identified and categorized into three groups based on clinical utility.

Expert opinion: The clinical relevance of any monitoring technique depends on its dynamic or static properties, the clinical setting (in sleep or wakefulness) and alignment with the specific clinical objectives within the OAT workflow. While static imaging and endoscopic-based methods offer anatomical and functional insights, only sleep-based assessments can capture treatment efficacy in clinically meaningful terms. Among alternative technologies for sleep testing, MJM analysis stands out as a promising approach for continuous and reliable monitoring, with ability to evaluate the dynamic, synchronized mechanisms underlying OAT efficacy.

Introduction: Mechanical thrombectomy for acute ischemic stroke is often limited by the tortuous anatomy and the 'ledge effect' caused at the junction of a large-bore aspiration catheter and smaller inner devices. Novel delivery assist catheters with smooth tapered distal tips have been developed to facilitate the navigation of aspiration or microcatheters to the clot.

Methods: We performed a PRISMA-guided systematic review of these tapered delivery assist catheters, analyzing their design, regulatory status, and all available evidence on technical performance, clinical outcomes, and safety. A comprehensive literature search (through July 2025) was conducted for studies and reports on the above devices.

Results: A total of 18 reports met the inclusion criteria, covering 7 distinct assist catheters. All devices share a common design of a variably stiff, single-lumen catheter with an atraumatic tapered distal segment that minimizes the gap between the inner device and the outer aspiration catheter. Use of these catheters enabled successful trackability and clot engagement in >90% of cases across most series, often without a guidewire, and with low complication rates.

Conclusions: Tapered delivery assist catheters represent an innovation in thrombectomy. Ongoing studies and broader adoption will further clarify their impact on procedural efficiency and patient outcomes.

Introduction: Mammography has been a cornerstone of breast cancer screening for decades, demonstrating population-level reductions in breast cancer mortality. Limitations of mammography include reduced sensitivity in dense breast tissue, false-positive recalls and biopsies, and possible overdiagnosis. Emerging mammography technologies, including digital breast tomosynthesis (DBT), contrast-enhanced mammography (CEM), and artificial intelligence (AI) applications, seek to address these limitations and improve screening outcomes.

Areas covered: In this review, we discuss endpoints for the assessment of emerging mammography technologies, including cancer detection, interval cancer, and advanced cancer rates. We review clinical trial data for DBT, highlighting studies reporting interval and advanced cancer rates, and contrast performance in average-risk and high-risk populations. We review CEM as a new modality for supplemental screening in women with dense breasts. Lastly, we cover the rapidly expanding space of AI-supported mammography tools, including those for lesion detection, exam triage, breast density assessment, and risk prediction.

Expert opinion: Emerging technologies in digital screening mammography have demonstrated improvements in surrogate endpoints like cancer detection, however, their effect on clinically meaningful outcomes such as interval cancer and advanced cancer reduction remains unproven. To ensure that innovations translate into tangible patient benefit, future research should prioritize clinically relevant endpoints and real-world evaluation.

Introduction: Pediatric patients with high-degree or complete atrioventricular block require permanent pacing. Pacing in this population is challenging due to changes in age, body and heart size, vascular anatomy, associated congenital abnormalities, physical activity, and expected long-term pacing needs.

Areas covered: This review evaluates recommendations, strategies, limitations, and complications of pediatric pacing, based on a comprehensive literature search (PubMed, using keywords as cardiac pacing, children, pacing complications, etc.). Currently, no pacing devices or leads are specifically designed for children; adult systems are adapted for pediatric use. Recommendations and strategies vary according to age, size, and associated congenital heart defects. Guidelines published between 2021 and 2023 provide updated recommendations. Advances in tools and techniques have improved management of pediatric bradyarrhythmias. Both transvenous and epicardial pacing systems can be implanted, with generally good outcomes, although complications remain relatively frequent.

Expert opinion: Cardiac pacing in children is effective and safe, but no single approach fits all patients. Implantation strategies, device selection, and techniques should be individualized based on patient characteristics, anatomy, and long-term needs. Future improvements in device design, lead technology, and procedural approaches will further optimize outcomes and reduce complications in this population.

Introduction: Obstructive sleep apnea (OSA) is a treatable risk factor for hypertension. Continuous Positive Airway Pressure (CPAP) and mandibular advancement devices (MAD) are effective treatments for OSA and have been shown to improve blood pressure in OSA.

Areas covered: This review explores the role of CPAP and MAD in the treatment of OSA for blood pressure control. Important clinical phenotypes associated with improved blood pressure in OSA are explored. A PubMed search of relevant articles within the past 10-years was performed.

Expert opinion: OSA therapy is shifting from a one-size-fits-all toward a precision medicine approach. Both CPAP and MAD have been demonstrated to reduce blood pressure in selected OSA patients. Neutral randomized controlled trials add to the uncertainty of treating OSA for the reduction of cardiovascular risk. Further work is needed to identify individual patients who are likely to gain a cardiovascular benefit from OSA treatment, including a reduction in blood pressure. Recent advances in wearable devices and sensor technologies present exciting opportunities for improving patient compliance with OSA therapy, monitoring long-term outcomes, and informing precision medicine approaches in clinical practice to improve blood pressure management in OSA.

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.