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Specialty: Neurosurgery
Management: Food and Drug Administration (FDA)

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Total 7 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

Validation of TURN, a simple Predictor of Symptomatic Intracerebral Hemorrhage after IV Thrombolysis
Intravenous thrombolysis (rt-PA) remains the only medical treatment for acute ischemic stroke approved by the Food and Drug Administration (FDA), but carries a substantial risk for symptomatic intracerebral hemorrhage (sICH) [1]. Predictive scores for sICH may help improve the safety profile for rt-PA treatment.
Source: Clinical Neurology and Neurosurgery - April 21, 2016 Category: Neurosurgery Authors: David Asuzu, Karin NystrÓ§m, Hardik Amin, Joseph Schindler, Charles Wira, David Greer, Nai Fang Chi, Janet Halliday, Kevin N. Sheth 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

State-of-the-Art Endovascular Treatment of Acute Ischemic Stroke.
Authors: Raphaeli G, Mazighi M, Pereira VM, Turjman F, Striefler J Abstract Stroke is the third leading cause of death in the USA. An estimated 795,000 new or recurrent stroke events occur annually, mostly ischemic in nature. Arterial recanalization and subsequent reperfusion performed shortly after symptom onset can help to restore brain function in acute ischemic stroke (AIS). The only treatment currently approved by the United States Food and Drug Administration is intravenous tissue plasminogen activator, administered within 4.5 h of symptom onset. However, this short window often precludes effective interventi...
Source: Advances and Technical Standards in Neurosurgery - December 1, 2014 Category: Neurosurgery Tags: Adv Tech Stand Neurosurg Source Type: research

Endovascular stroke intervention in the very young
Stroke remains the leading cause of adult permanent disability and the third-leading cause of death in United States [1]. In USA, the incident of new or recurrent stroke is approximately 795,000 per year [2], and is predicted to increase to 1.2 million per year by 2025 [3]. It is not surprising, giving these numbers, that the management of stroke is consistently evolving and includes medical treatment as well as interventional management such as open and endovascular surgery. Medical treatment consists of intravenous (IV) recombinant tissue plasminogen activator (rtPA), which is the only therapy approved by the Food and Dr...
Source: Clinical Neurology and Neurosurgery - October 3, 2014 Category: Neurosurgery Authors: Mario Zanaty, Nohra Chalouhi, Robert M. Starke, Stavropoula Tjoumakaris, David Hasan, Shannon Hann, Norman Ajiboye, Kenneth C. Liu, Robert H. Rosenwasser, Philip Manasseh, Pascal Jabbour Source Type: research