Filtered By:
Source: Journal of NeuroInterventional Surgery
Management: Food and Drug Administration (FDA)

This page shows you your search results in order of date.

Order by Relevance | Date

Total 4 results found since Jan 2013.

Republished:Aspiration catheter failure leading to carotid-cavernous fistula during stroke thrombectomy
We present a case of a previously unreported complication related to malfunction of a Penumbra aspiration catheter during stroke thrombectomy resulting in a carotid-cavernous fistula.
Source: Journal of NeuroInterventional Surgery - February 14, 2023 Category: Neurosurgery Authors: Agrait, M., Kee-Sampson, J., Brzezicki, G., Bashir, S., Matteo, J., Meyer, T., Siragusa, D. Tags: Ischemic stroke Source Type: research

O-005 Comparison of on-label versus off-label treatment of intracranial aneurysms with the pipeline embolization devices
ConclusionIn real-world practice, off-label uses of PED can achieve similar safety and efficacy to on-label uses, though there may be a slightly higher rate of ischemic complications in off-label uses. Expert judgment is a useful supplement to official guidelines when assessing reasonable PED use beyond its approved indications.Disclosures S. Cler: None. D. Lauzier: None. A. Kansagra: 2; C; Penumbra, Microvention, iSchemaView.
Source: Journal of NeuroInterventional Surgery - July 26, 2021 Category: Neurosurgery Authors: Cler, S., Lauzier, D., Kansagra, A. Tags: Oral abstracts Source Type: research

The long winding road towards certification in neuroendovascular surgery
 "Alea Jacta Est" (The Die is Cast) Gaius Julius Cesar, January 10, 49 BC Over the last two decades there has been a revolution in the treatment of cerebrovascular diseases. The innovative approach of interventional radiology to a minimally invasive endovascular treatment of vascular diseases has been successfully translated into the vascular neurosurgery realm. A major step in this direction was the Food and Drug Administration (FDA) approval of the Guglielmi Detachable Coils (GDC) on September 8, 1995.1 2 Twenty years later, five multicenter randomized clinical trials provided Class 1, Level A evidence that endovasc...
Source: Journal of NeuroInterventional Surgery - April 13, 2016 Category: Neurosurgery Authors: Linfante, I. Tags: Editor ' s column Source Type: research

Watching, but not waiting: vascular neurology perspective on the disparate regulatory pathways for stroke
Vascular neurologists have keenly watched the Watchman device (Atritech, Plymouth, Minnesota, USA) regulatory approval process. We are, as always, searching for additional options in the prevention and treatment of stroke to better care for our patients, and new approaches to the management of atrial fibrillation play a large part in this effort. Recently, a Food and Drug Administration (FDA) panel voted 13:1 in favor of the Watchman device for the prevention of ischemic stroke in non-valvular atrial fibrillation.1 The panelists came to this decision after reviewing data from large randomized trials that compared anticoagu...
Source: Journal of NeuroInterventional Surgery - May 14, 2015 Category: Neurosurgery Authors: Sheth, S. A., Nogueira, R. G., Noorian, A. R., Liebeskind, D. S. Tags: Editorials Source Type: research