Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

: In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing the placing on the market of medical devices is decentralized to independent 'conformity assessment' organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details-which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe

Human skeletal remains from the Middle Bronze Age cemetery of Sant'Abbondio (Pompeii, Italy)

In this work, the human skeletal remains from the Middle Bronze Age cemetery of Sant'Abbondio (Pompeii, Naples, Southern Italy) are studied. They represent so far the only Middle Bronze Age human paleobiological evidence from Campania. The skeletal assemblage reveals to be homogeneous in its skeletal and dental features. The comparison with other known contexts is offered to insert the population in the archaeological and anthropological framework known for this moment of prehistory. New and partially innovative data emerging from the study of Sant'Abbondio population contribute to an improved understanding of Bronze Age Italy

Nitric oxide modulation neutrophil-endotelium interaction: difference between arterial and venous bypass grafts.

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The effects of creatine phosphate in experimental myocardial infarction

Several clinical and experimental studies have demonstrated the protective mechanisms of exogenous high-energy compounds in treating total or regional myocardial ischemia. To evaluate the effects of creatine phosphate (CP) in an experimental model, rabbits of the New Zealand line were randomly divided into two CP-treated groups (A and B) and one control group (C). In all animals the circumflex coronary artery was ligated, and the size of the infarct zone was planimetrically determined. The contents of the phospholipid degradation products also were measured. Continuous electrocardiogram monitoring revealed a statistically significant reduction in the total number of ventricular ectopic beats in groups A and B and a longer period of both ventricular tachycardia and ventricular fibrillation in the control group than in the treated groups. Our results showed a statistically significant reduction of the necrotic zone in both treated groups versus the control group. Analysis of the degradation products of phospholipid metabolism emphasized an increase of both lysophosphatidylcholine and lysophosphatidylethanolamine in the untreated group versus treated groups. Significant correlation was found between total ventricular ectopic beats and the lysophosphoglyceride contents in groups A and B. On this basis we believe that CP may prevent the ischemic consequences on the myocardium of arrhythmias resulting from electrophysiological alterations produced by an increase of lysophosphoglycerides, and should reduce the extension of the necrotic zone, probably preserving the integrity of the cell membrane. © 1996, All rights reserved