The Food and Drug Administration Medical Device Review Process

Felten, Richard P.; Ogden, Neil; Peña, Carlos; Provost, M. C.; Schlosser, Michael; Witten, Celia

doi:10.1161/01.str.0000153063.54972.91

Cited by 44 publications

(17 citation statements)

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“…In addition, the U.S. Food and Drug Administration (FDA) assesses devices for revascularization according to their ability to restore blood flow. 2 However, despite attempts to define reporting standards for thrombolysis trials, 3 the acute stroke literature currently lacks a standard convention for describing this critical end point. Trials, studies, and case series have used the terms "recanalization" and "reperfusion," or sometimes both interchangeably, to describe revascularization.…”

mentioning

confidence: 99%

Revascularization End Points in Stroke Interventional Trials

Khatri

Neff

Broderick

et al. 2005

Stroke

220

168

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Background and Purpose-The acute stroke literature lacks a standard convention regarding the critical end point of revascularization. Two distinct parameters may be clinically important: (1) recanalization of the primary arterial occlusive lesion (AOL) and (2) global reperfusion of the distal vascular bed. We sought to determine their relationship in the Interventional Management of Stroke (IMS) Phase I trial of combined intravenous (IV) and intraarterial (IA) recombinant tissue plasminogen activator. Methods-Sixty-one angiograms were reanalyzed using recanalization and reperfusion scores. The AOL Score was defined as: 0ϭno recanalization of the primary occlusion, Iϭincomplete or partial recanalization of the primary occlusion with no distal flow, IIϭincomplete or partial recanalization of the primary occlusion with distal flow, or IIIϭcomplete recanalization of the primary occlusion with distal flow. The Thrombolysis in Myocardial Infarction (TIMI) Score was defined as: 0ϭno perfusion, 1ϭperfusion past the initial occlusion but no distal branch filling, 2ϭperfusion and incomplete or slow distal branch filling, or 3ϭfull perfusion with filling of all distal branches. We compared the 2 scores with one another and with good clinical outcome (modified Rankin Score zero to 2). Key Words: acute Rx Ⅲ acute stroke Ⅲ interventional neuroradiology T hrombolytic revascularization is the only proven, effective way to reverse neurologic deficit in acute ischemic stroke. 1 Newer revascularization strategies are often assessed, at least in part, based on their ability to restore flow. In addition, the U.S. Food and Drug Administration (FDA) assesses devices for revascularization according to their ability to restore blood flow. 2 However, despite attempts to define reporting standards for thrombolysis trials, 3 the acute stroke literature currently lacks a standard convention for describing this critical end point. Trials, studies, and case series have used the terms "recanalization" and "reperfusion," or sometimes both interchangeably, to describe revascularization. Moreover, definitions of each term vary. Results-AOLTwo distinct parameters that may be critical in the assessment of revascularization are (1) recanalization of the primary arterial occlusive lesion (AOL) and (2) global reperfusion of the distal vascular bed. Distinguishing between these parameters may be clinically important. For example, an artery may be completely recanalized, but distal clot embolization may limit distal reperfusion. This may limit significant neurologic recovery and could theoretically increase the risk of hemorrhage as a result of local hyperperfusion in ischemic brain regions. On the other hand, distal reperfusion may be achieved, but the artery may have incomplete recanalization (ie, residual clot at the primary occlusive site) predisposing to a higher rate of reocclusion with subsequent clinical deterioration. 4 Drugs, devices, or combinations may differ in their ability to achieve and maintain recanalization and reperfusion.Heterogeneo...

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confidence: 99%

Revascularization End Points in Stroke Interventional Trials

Khatri

Neff

Broderick

et al. 2005

Stroke

220

168

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“…20,21 The evaluation of combined interventions should be appropriately tailored to nature of the combination, ie, drugsϩdevices. FDA assigns an agency component to lead the review and regulation of such combinations based on its determination of the "primary mode of action" of the combination product.…”

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confidence: 99%

Recommendations From the STAIR V Meeting on Acute Stroke Trials, Technology and Outcomes

Fisher

Hanley

Howard

et al. 2007

Stroke

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“…Other advances in the management of acute ischemic stroke include recent FDA clearance of the MERCI Retriever for US marketing. 11,12,13 In comparison to tissue plasminogen activator, the MERCI retriever is intended to remove thrombus obstructing blood flow in the neurovasculature as cause of acute ischemic stroke (the MERCI Retriever had been previously cleared by the FDA for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature). Patients who are ineligible for treatment with IV tissue plasminogen activator or who fail IV tissue plasminogen activator therapy are candidates for intervention with the MERCI retriever.…”

Section: What Clearance For Marketing Means To the Usermentioning

confidence: 99%

“…The FDA also involved its advisory panel in the review of data for the MERCI retriever, and FDA considered comments made by advisory panel members very carefully when evaluating the evidence submitted by the manufacturer. 11 Because the primary end point of this study was restoration of cerebral circulation and not improved clinical outcome after stroke, and because of the nonrandomized design, the MERCI retriever was cleared with an indication for use regarding cerebral revascularization after stroke and not an indication for use of acute stroke treatment. Although this may appear clinically to be an arbitrary distinction, this distinction was necessary because the data supporting market clearance was determined by radiographic evidence for accomplishing this end point and one of several considerations that the agency used in clearance of the device.…”

Section: What Clearance For Marketing Means To the Usermentioning

confidence: 99%

An Example of US Food and Drug Administration Device Regulation

Peña

Felten

et al. 2007

Stroke

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Abstract-The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the agency that is responsible for pre-and postmarket regulation of medical devices. In this article, we review current regulation of medical devices, research and development programs, pre-and postmarket perspectives, and future considerations of medical devices, particularly as they relate to devices targeting acute ischemic stroke as an example of the process. We also review the Center for Devices and Radiological Health's historical perspective of acute ischemic stroke trials and clinical trial design considerations used in prior studies that have led to US market clearance as they are related to currently marketed devices indicated for acute ischemic stroke.

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The Food and Drug Administration Medical Device Review Process

Cited by 44 publications

References 0 publications

Revascularization End Points in Stroke Interventional Trials

Revascularization End Points in Stroke Interventional Trials

Recommendations From the STAIR V Meeting on Acute Stroke Trials, Technology and Outcomes

An Example of US Food and Drug Administration Device Regulation

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