Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Apr 6th, 2017

London, --

GB

https://management-forum.co.uk/product/details/2269

Phone:+44 (0) 20 7749 4730

This seminar provides an essential overview of medical device clinical evaluations, clinical investigations, postmarket clinical follow-up requirements, and adverse event and vigilance reporting for medical device clinical studies.

Images in a 74-year-old male patient who presented at the hospital with acute symptoms of a right hemispheric ischemic stroke and a National Institutes of Health Stroke Scale (NIHSS) score of 24. (A) Nonenhanced CT image shows no signs of early infarction, whereas (B) CT perfusion image shows a large perfusion deficit in the territory of the middle cerebral artery and anterior cerebral artery caused by an extracranial occlusion in the right internal carotid artery. (C) Digital subtraction angiography shows the occlusion in the C1 segment. The extracranial occlusion was passed, reperfused, and subsequently stented (D, E). The final contrast injection did not reveal any intracranial occlusions within the territory of the internal carotid artery (F). At the 24-hour follow-up, there was no infarction on (G) the nonenhanced CT image, and the NIHSS score had decreased to 3 points. Image courtesy of RSNA.

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Images in a 74-year-old male patient who presented at the hospital with acute symptoms of a right hemispheric ischemic stroke and a National Institutes of Health Stroke Scale (NIHSS) score of 24. (A) Nonenhanced CT image shows no signs of early infarction, whereas (B) CT perfusion image shows a large perfusion deficit in the territory of the middle cerebral artery and anterior cerebral artery caused by an extracranial occlusion in the right internal carotid artery. (C) Digital subtraction angiography shows the occlusion in the C1 segment. The extracranial occlusion was passed, reperfused, and subsequently stented (D, E). The final contrast injection did not reveal any intracranial occlusions within the territory of the internal carotid artery (F). At the 24-hour follow-up, there was no infarction on (G) the nonenhanced CT image, and the NIHSS score had decreased to 3 points. Image courtesy of RSNA.

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