Expert Review of Medical Devices最新文献

Aim: The aim of the present study was to propose the clinical efficacy of the different dentin matrix obtained from three devices (BonMaker, Tooth Transformer, and Smart Dentin Grinder) and to show their morphological, physical, and biochemical characteristics using scanning electron microscopy (SEM), energy-dispersive X-ray (EDX) spectroscopy, and Raman spectroscopy.

Research design and methods: The study included 70 patients who underwent bone augmentation using the BonMaker, Tooth Transformer, and Smart Dentin Grinder devices. In addition, 84 implants were placed. Furthermore, four samples, one for each device and one non-demineralized control, were analyzed with scanning electron microscopy (SEM), energy-dispersive X-ray analysis, and Raman spectroscopy.

Results: In all patients, augmentation of bone defects with ground dentin matrix was successful, and implants showed correct osseointegration. The morphological organization, the chemical composition, and the presence of organic molecules in the dentin samples processed by the three different devices were demonstrated using SEM, energy-dispersive X-ray analysis, and Raman spectroscopy.

Conclusions: Comparing BonMaker, Tooth Transformer, and Smart Dentin Grinder devices in our practice, we concluded that these systems, even with different structural and chemical differences of the dentin granules, have a comparable potential for obtaining regenerative material from the patient's own teeth.

Introduction: Liver-dominant metastatic colorectal cancer is noted in approximately 20%-35% of the patients. Systemic chemotherapy remains the first-line treatment for mCRC, but the prognosis is poor due to liver failure. Novel minimally invasive technologies have enabled the optimization of locoregional treatment options.

Areas covered: This is a comprehensive review of novel locoregional treatment technologies, both percutaneous ablation and transcatheter arterial treatments, which can be used to decrease hepatic disease progression in patients with mCRC. Trans-arterial radioembolization is the most recently developed locoregional treatment for metastatic liver disease, and robust evidence has been accumulated over the past years.

Expert opinion: Image-guided techniques, endovascular and ablative, have gained wide acceptance for the treatment of liver malignancies, in selected patients with non-resectable disease. The optimization of dosimetry and microsphere technological advancement will certainly upgrade the role of liver radioembolization segmentectomy or lobectomy in the upcoming years, due to its curative intent. Also, ablative interventions provide local curative intent, offering significant and sustained local tumor control. Standardization protocols in terms of predictability and reliability using immediate treatment assessment and ablation zone software could further ameliorate clinical outcomes.

Introduction: The impact of robotic-assisted total knee arthroplasty (rTKA) vs. traditional, manual TKA (mTKA) on hospital costs is not well documented and is analyzed herein.

Research design and methods: Patients in the Premier billing Healthcare Database undergoing elective rTKA or mTKA ("index') in the in- or outpatient setting for knee osteoarthritis between Oct 1^st, 2015, to September 30th, 2021, were identified. Variables included patient demographics and comorbidities and hospital characteristics. Matched rTKA vs. mTKA cohorts were created using direct (on provider characteristics, age, gender, race and Elixhauser index) and propensity score matching (fixation type, comorbidities). Index and 90-day inflation-adjusted costs and healthcare utilization (HCU) were analyzed for both cohorts, using generalized linear models.

Results: 16,714 rTKA patients were matched to 51,199 mTKA patients. Average 90-day hospital cost reached $17,932 and were equivalent for both cohorts (rTKA vs. mTKA: $132 (95% confidence interval; -$19 to $284). There was a 2.7% (95%CI: 2.2%-3.3%) increase in home or home health discharge, and a 0.4% (95%CI: 0%-0.8%) decrease in 90-day hospital knee related re-visit in the rTKA vs. mTKA group.

Conclusions: Cost-neutrality of rTKA vs. mTKA was observed, with a potential for lowered immediate post-operative HCU in the rTKA vs. mTKA cohorts.

Introduction: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that should increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to accelerated MD approval programs elsewhere (e.g. US).

Areas covered: Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in premarket clinical evidence generation and lack of oversight for post approval evidence requirements. Implications for MD approval, HTA and coverage are explored.

Expert opinion: Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed to fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers' evidence generation plans along the MD lifecycle (pre, postmarket), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.

Background: Powered intraosseous (IO) systems are valuable devices for emergent situations, with limited data on user preferences. A simulation/survey-based study was conducted among emergency medical service (EMS) providers to evaluate attitudes toward general powered IO system features to measure preferences/satisfaction for the most-commonly used and a novel powered IO system (with a passive safety needle, battery life indicator, and snap-securement/dressing).

Research design and methods: Forty-two EMS providers completed a simulated activity using both powered IO systems and a 30-item questionnaire, including multiple choice, free-text, ranking, and Likert-like questions. Ranking scores were reported using a scale of 0 (least important/satisfactory) to 100 (most important/satisfactory). Statistical significances were evaluated via Wilcoxon signed-rank sum test.

Results: Providers indicated driver performance (mean score ± SD; 77.8 ± 27.5) and IO needle safety mechanism (63.1 ± 27.9) as the most important features. Participants reported significantly higher (p < 0.001) satisfaction with the novel IO system overall, and its needle safety, battery life indicator, securement/dressing, and ease-of-use. Powered driver performance satisfaction was similar and favorable for the novel (88.1 ± 18.2) and traditional (87.1 ± 15.3) systems.

Conclusions: These findings highlight the value of clinician/user input and demonstrate EMS providers are more satisfied with a powered IO system featuring design elements intended to enhance safety and ease-of-use.

Introduction: Worldwide medical device regulatory authorities increasingly rely on the benefit-risk ratio for decision-making. However, current benefit-risk assessment (BRA) methods are mostly descriptive, not quantitative.

Areas covered: We aimed to summarize the regulatory requirements of BRA, discuss the feasibility of adopting multiple criteria decision analysis (MCDA), and explore factors for optimizing the MCDA for quantitative BRA of devices.

Expert opinion: Regulatory organizations emphasize BRA in their guidance, and some recommend user-friendly worksheets to conduct qualitative/descriptive BRA. The MCDA is considered one of the most useful and relevant quantitative BRA methods by pharmaceutical regulatory agencies and the industry; the International Society for Pharmacoeconomics and Outcomes Research summarized the principles and good practice guidance of MCDA. We recommend optimizing the MCDA by considering the following unique characteristics of the device BRA: using data from state of the art as a control and clinical data from post-market surveillance and literature; considering the device's diverse characteristics when selecting controls; assigning weight according to type, magnitude/severity, and duration of benefits and risks; and including physician and patient opinions in the MCDA. This article is the first to explore using MCDA for device BRA and might lead to a novel quantitative BRA method for devices.

Introduction: Compartment syndrome (CS) continues to be a legitimate orthopedic emergency as it leads to thousands of amputations and permanent nerve and tissue damage to undiagnosed patients for more than eight hours. In CS, intracompartmental pressure is elevated, causing reduced blood flow inside the limb compartments. An erroneous diagnosis may result in unnecessary fasciotomies, the only treatment for this condition.

Areas covered: This review examines the previous and current diagnostic and therapeutic practices for compartment syndrome. It also performs a comparative analysis of each diagnostic technique and its foresights.

Expert opinion: Currently, most clinicians rely on a physical examination of the patient to diagnose CS. The primary reason for the physical examination is the lack of a gold-standard device. The invasive intracompartmental pressure (ICP) measurement technique is still the most commonly used. On the other hand, many noninvasive approaches have the potential to be used as diagnostic tools; however, more research is needed before they can be accepted as standard clinical approaches.

Introduction: The rapid growth of the medical device industry has driven the evolution of regulatory guidance on medical device clinical evaluation (MDCE) of the China National Medical Products Administration (NMPA), which consequently influences pre-market and post-approval clinical evaluation (CE) strategies.

Areas covered: We aimed to investigate the 3-stage evolution of NMPA regulatory guidance on MDCE (1. The era before specific CE guidance, 2. 2015 CE Guidance, and 3. 2021 CE Guidance Series), analyze the gaps between each stage, and assess the evolution's impact on pre-market and post-approval CE strategies.

Expert opinion: The fundamental principles of the NMPA 2021 CE Guidance Series were transformed from the 2019 International Medical Device Regulatory Forum documents. Compared with the 2015 guidance, the 2021 CE Guidance Series further clarifies the CE definition by emphasizing the ongoing activity of CE through an entire product lifecycle and the use of scientifically sound methods for CE and narrows the pre-market CE pathways into the equivalent device and clinical trial pathways. The 2021 CE Guidance Series simplifies the process for selecting the pre-market CE strategy but does not specify post-approval CE update cadency and general requirements for post-market clinical follow-up.

Introduction: Extracorporeal membrane oxygenation (ECMO) is primarily used for the supportive treatment of patients suffering from severe cardiopulmonary failure. With the continued development of ECMO technology, the relevant scenarios also extend pre-hospital and inter-hospital. In order to meet the needs of emergency treatment in communities, disaster sites and battlefields, inter-hospital transfer and evacuation; miniaturized and portable ECMO has become a current research hotspot.

Area covered: The paper first introduces the principle, composition and common modes of ECMO and summarizes the research status of portable ECMO, Novalung and wearable ECMO, analyzes the characteristics and shortcomings of existing equipment. finally, we discussed the focus and development trend of portable ECMO technology.

Expert opinion: Currently, portable ECMO has many applications in interhospital transport and there are various studies on portable and wearable ECMO devices, but the development of portable ECMO still faces many challenges. In the future, research related to integrated components, rich sensor arrays, Intelligent ECMO system and lightweight technology can make future portable ECMO more suitable for pre-hospital emergency and interhospital transport.