Current Issue : January - March Volume : 2014 Issue Number : 1 Articles : 5 Articles
Background: Classical mechanical dilators for cervical dilation are associated with\r\nvarious complications, such as uterine perforation, cervical laceration, infections and\r\nintraperitoneal hemorrhage. A new medical device called continuous controllable\r\nballoon dilator (CCBD) was constructed to make a significant reduction in all of the\r\nside effects of traditional mechanical dilation.\r\nMethod: In this study we investigated numerically the cervical canal tissue response\r\nfor Hegar and CCBD using our poroelastic finite element model and in-house\r\nsoftware development. Boundary conditions for pressure loading on the tissue for\r\nboth dilators in vivo were measured experimentally. Material properties of the\r\ncervical tissue were fitted with experimental in vivo data of pressure and fluid\r\nvolume or balloon size.\r\nResults: Obtained results for effective stresses inside the cervical tissue clearly\r\nshowed higher stresses for Hegar dilator during dilation in comparison with our\r\nCCBD.\r\nConclusion: This study opens a new avenue for the implementation of CCBD device\r\ninstead of mechanical dilators to prevent cervical injury during cervical dilation...
Background: Common cold is caused by a variety of respiratory viruses. The prevalence in children is high, and it\r\npotentially contributes to significant morbidity. Iota-carragenan, a polymer derived from red seaweed, has reduced\r\nviral load in nasal secretions and alleviated symptoms in adults with common cold.\r\nMethods: We have assessed the antiviral and therapeutic activity of a nasal spray containing iota-carrageenan in\r\nchildren with acute symptoms of common cold. A cohort of 153 children between 1ââ?¬â??18 years (mean age 5 years),\r\ndisplaying acute symptoms of common cold were randomly assigned to treatment with a nasal spray containing\r\niota-carrageenan (0.12%) as verum or 0.9% sodium chloride solution as placebo for seven days. Symptoms of\r\ncommon cold were recorded and the viral load of respiratory viruses in nasal secretions was determined at two\r\nconsecutive visits.\r\nResults: The results of the present study showed no significant difference between the iota carrageenan and the\r\nplacebo group on the mean of TSS between study days 2ââ?¬â??7. Secondary endpoints, such as reduced time to\r\nclearance of disease (7.6 vs 9.4 days; p = 0.038), reduction of viral load (p = 0.026), and lower incidence of secondary\r\ninfections with other respiratory viruses (p = 0.046) indicated beneficial effects of iota-carrageenan in this population.\r\nThe treatment was safe and well tolerated, with less side effects observed in the verum group compared to\r\nplacebo.\r\nConclusion: In this study iota-carrageenan did not alleviate symptoms in children with acute symptoms of\r\ncommon cold, but significantly reduced viral load in nasal secretions that may have important implications for\r\nfuture studies....
Background: Scientific evidence supports decision-making on the use of implantable medical devices (IMDs) in\r\nclinical practice, but IMDs are thought to be far less investigated than drugs. In the USA, studies have shown that\r\napproval process of high-risk medical devices was often based on insufficiently robust studies, suggesting that\r\nevidence prior to marketing may not be adequate. This study aimed to ascertain level of evidence available for\r\nIMDs access to reimbursement in France.\r\nMethods: The objective was to examine the scientific evidence used for IMDs assessment by the French National\r\nAuthority for Health. We collected all public documents summarising supportive clinical data and opinions\r\nconcerning IMDs issued in 2008. An opinion qualifies the expected benefit (EB) of the IMD assessed as sufficient or\r\ninsufficient, and if sufficient, the level of improvement of the expected benefit (IEB) on a scale from major (level I)\r\nto no improvement (level V). For each opinion, the study with the highest level of evidence of efficacy data, and its\r\ndesign were collected, or, where no studies were available, any other data sources used to establish the opinion.\r\nResults: One hundred and two opinions were analysed, with 72 reporting at least one study used for assessment\r\n(70.6%). When considering the study with the highest level of evidence: 34 were clinical non-comparative studies\r\n(47.2%); 29 were clinical comparative studies of which 25 randomised controlled trials (40.3%); 5 were meta-analyses\r\nof randomised controlled trials (6.9%); and 4 were systematic literature reviews (5.6%). The opinions were\r\nsignificantly different according to the study design (p < 0.001). The most frequent design for insufficient EB, IEB\r\nlevel V and IEB level IV was a non-comparative study (10/19, 52.6%; 15/24, 62.5%; and 8/15, 53.3%; respectively). For\r\nthe 30 opinions with no supporting clinical study, 16 (53.3%) were based on an expert-based process, 9 (30.0%)\r\nwere based on the conclusions of a previous opinion (all concluding IEB level V), and 5 (16.7%) reported no data\r\n(concluding insufficient EB for 4 and IEB level V for 1).\r\nConclusions: This study confirmed that level of evidence of clinical evaluation of IMDs is low and needs to be\r\nimproved....
About 500,000 elderly people in Switzerland suffer a fall each year.Thus medical attention and help are essential for these people,\r\nwho mostly live alone without a caregiver. Only 3% of people aged over 65 in Switzerland use an emergency system. Personal\r\ntelehealth devices allow patients to receive enough information about the appropriate treatment, as well as followup with their\r\ndoctors and reports of any emergency, in the absence of any caregiver.This increases their quality of life in a cost-effective fashion.\r\nââ?¬Å?Limmexââ?¬Âââ?¬â?a new medical emergency watchââ?¬â?was launched in Switzerland in 2011 and has been a great commercial success. In this\r\npaper, we give a brief review of this watch technology, along with the results of a survey of 620 users conducted by the Department\r\nof Emergency Medicine in Bern....
Funding: This study was supported by funding from the Medical Device Initiative from the Pew Charitable\r\nTrusts. DBK is the Lois Green Scholar at the Hebrew SeniorLife Institute for Aging Research and is supported in\r\npart by a career development award from the Harvard Catalyst Clinical and Translational Research Center. DBK\r\nreports serving as a consultant to the US FDA�s Circulatory Systems Advisory Panel. ASK is also supported by a\r\ncareer development award from the Agency for Healthcare Research & Quality (K08HS18465-01), and a Robert\r\nWood Johnson Foundation Investigator Award in Health Policy Research. The funders had no role in the\r\ndecision to publish or preparation of the manuscript.\r\nCompeting Interests: ASK is a member of the Editorial Board of PLOS Medicine. DBK and ASK previously were\r\nawarded a research contract by the US FDA/CDRH to conduct an independent research project (one piece of\r\nwhich was published in PLOS Medicine). DBK reports serving as a consultant to Circulatory Systems Advisory\r\nPanel of the US FDA. DBK and ASK previously published research funded by US FDA on comparative medical\r\ndevice regulation. DBK and ASK are also supported in part by US NIH career development awards. CS is a\r\nmember for the OECD Advisory Panel of Experts in Health Information Infrastructure, 2013-14, without any\r\npayment. YTT has declared that no competing interests exist.\r\nAbbreviations: CA, Competent Authority; EUDAMED, European Databank on Medical Devices; FDA,\r\nUS food and Drug Administration; FSCA, Field Safety Corrective Action; HDE, Humanitarian Device\r\nExemption; MHLW, Japan Ministry of Health, Labor, and Welfare; MHRA, UK Medicine and Healthcare\r\nProducts Regulatory Agency; MOH, China Ministry of Health; NVB, Notified Body; PMA, premarket approval;\r\nPMDA, Japan Pharmaceuticals and Medical Devices Agency; PS, postmarket surveillance; SFDA, China State\r\nFood and Drug Administration; UDI, unique device identifier....
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