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Medical device manufacturers conduct clinical studies in Italy for various reasons, including the size of the Italian market and the presence of leading health-technology centres. This article discusses the manner in which the European requirements for medical device clinical investigations are interpreted and enforced in Italy.
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BACKGROUND: Although distal embolic protection (DEP) is increasingly utilized in saphenous vein graft percutaneous coronary intervention (SVG PCI), the clinical and economic outcomes of different DEP strategies are unknown. METHODS: We compared 3 DEP strategies (no DEP, routine DEP, selective DEP in high-risk cases) in 126 consecutive cases of SVG PCI performed without DEP in a single catheterization laboratory over a 4-year period. No SVG PCI was excluded. High risk was defined using 2 multivariate predictors of embolic complication previously validated by NCDR (graft age greater than or equal to 8 years and or friable appearance with thrombus). Costs were determined by a ratio of cost-to-charges methodology and average cost of the two FDA-approved DEP devices ($1,350) with similar efficacy. RESULTS: Without DEP, the incidence of embolic complications was 17% (22/126), resulting in major adverse coronary events (MACE) in 3.2% (4/126) of all cases: 2 deaths, 1 myocardial infarction, and 1 emergency coronary artery bypass. Embolic complications significantly increased both procedure costs by $2,725 (p < .001) and total hospital costs approximately $2,800 (p < 0.05). Risk adjustment for selective DEP use correctly predicted 86% (19/22) of embolic complications, including all MACE, at an incremental cost of $684 per patient for selective DEP versus $1,150 per patient for routine DEP. Selective DEP would cost $43,127 per death prevented versus $72,461 using routine DEP during the index hospitalization. CONCLUSIONS: Embolic complications increase cost in excess of the cost of a DEP device. This risk adjustment model correctly predicted the majority of cases of embolic complication and all MACE, suggesting that selective DEP use may help reduce utilization of DEP by an almost 50% cost reduction compared to routine use.
As 2005 came to a close, the European Commission issued its formal proposal for a Directive amending the medical devices Directives. This article discusses certain aspects of the proposed amendments and encourages readers to review them in their entirety.
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(1) Cerebral protection devices offer a new approach to reducing the risk of stroke and death in patients undergoing carotid angioplasty with stenting (CAS). (2) Nine studies have examined the efficacy of cerebral protection devices, by comparing the incidence of procedure related stroke and death to that of CAS without protection, and to surgical endarterectomy. Few of the studies were of high quality. (3) Overall, the differences in the incidence of procedure-related stroke and death were not statistically significant among patients who underwent CAS without protection, compared to those who received CAS with protection, or to those who underwent endarterectomy. (4) Complications reported with the use of cerebral protection devices are minor and transient. (5) CAS with cerebral protection may offer a safe and efficacious alternative to endartectomy in symptomatic, high risk patients with severe carotid artery disease. Evidence to support the use of CAS with cerebral protection devices in asymptomatic patients who have severe carotid artery stenosis, is unavailable.
(1) The standard approach for the treatment of kidney (renal) cancer is radical or partial nephrectomy (removal of the kidney). (2) Radiofrequency ablation (RFA), a less invasive approach, is an option for the treatment of small tumours, and in cases where surgery is contraindicated. (3) Its safety and efficacy compare favourably with those of other approaches. (4) The persistence of residual tumour is a disadvantage of earlier versions of the technology. The use of more powerful radiofrequency (RF) generators may reduce such persistence, but definitive evidence is unavailable. (5) Experience with this application of the technology is limited. Longer follow-up of patients is required to provide an adequate comparison with nephrectomy.
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The Food and Drug Administration (FDA) is classifying Reagents for detection of specific novel influenza A viruses into class II (special controls). Special controls that will apply to the device are the guidance document entitled, "Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses" and limitations of distribution of these reagents. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is a special control for this device.
A combination product is a new model of the medical product that incorporates at least two of the regulated component categories of device, drug, or biological product into one product. It has become a new hot point within the development of devices and drugs, and has brought about a new opportunity for device and drug industries and a new challenge for administration too. In the paper, the properties of combination products are summed up and the impact on device and drug industries are discussed.
The expansion of applications of medical devices has attracted the increased attention of government regulatory bodies around the world to the safety and effectiveness of these products. Most developed countries, such as the United States and European Union, have developed well-established regulatory systems for medical devices, which have also consistently been amended to accommodate the changing requirements of safety and the trend of globalization.The current "Regulations for the Supervision and Administration of Medical Device (China)", established in 2000, has brought about great improvements for the safety and effectiveness of products, safeguarding public health. But there are still, at present, a lot of counterfeit and poor quality devices and device-related adverse events for lack of powerful post -market and in-use regulatory controls for products. It is therefore very urgent for the Chinese government to reform its medical device administration and management. This research paper analyses and compares the different requirements and executions of medical devices regulations in the EU, the US and China, to draw some experiences of the EU and US regimes that are very useful to China's regulatory reform. It is suggested that when developing a new scheme of medical devices regulatory reform in China, two prominent aspects have to be considered by policy makers and regulators. Firstly, the global trend of medical devices regulations has to be taken into account. Secondly, the experiences learned from the EU and US systems should be applied to the Chinese regulatory reform in combination with the concrete practice of China.
PURPOSE: We report on the optimal stent-graft (SG) size for Japanese patients with abdominal aortic aneurysm (AAA). MATERIALS AND METHODS: Ninety three Japanese patients undergoing elective AAA repair were selected for this study. The parameters measured were the proximal neck (PN) diameter (D1), the diameter of the right and left common iliac arteries (D2 and D3, respectively), the diameter of the right and left external iliac arteries (D4 and D5, respectively), the distance between the lowest renal artery and the common iliac arterial bifurcation (L1), and the distance between the right and left common iliac arterial bifurcations and the internal iliac arterial bifurcation (L2 and L3, respectively). RESULTS: The following results were obtained: D1: 20.7+/-3.9 mm (14 to 28 mm); D2: 14.0+/-3.0 mm (9.5 to 20 mm); D3: 13.8+/-3.1 mm (9 to 19.5 mm); D4: 7.5+/-1.0 mm (6 to 10 mm); D5: 7.4+/-0.9 mm (6 to 10 mm); L1: 107.7+/-13.4 mm (80 to 130 mm); L2: 40.0+/-10.1 mm (20 to 61 mm); L3: 39.7+/-9.6 mm (20 to 60 mm). CONCLUSION: The results indicate the necessity of exercising adequate care when selecting a device for Japanese patients.
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