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Total 8017 results found since Jan 2013.
The ROADSTER Investigational Device Exemption Trial Leads to Food and Drug Administration Approval of the First Stent Labeled for Trans-Carotid Artery Revascularization
Trans-carotid artery revascularization (TCAR) with the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, Calif) combines direct carotid access with blood flow reversal as cerebral protection during carotid stent placement. The Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) investigational device exemption trial studied TCAR using Food and Drug Administration (FDA)-approved carotid stent systems designed for transfemoral delivery.
Source: Journal of Vascular Surgery - August 23, 2016 Category: Surgery Authors: Manish Mehta, Vikran Kashyap, Mahmoud Malas, Philip Paty, Richard Cambria, Christopher Kwolek, Rasesh Shah, Enrique Criado, Robert Molnar Tags: Abstract from the 2016 Eastern Vascular Society Annual Meeting Source Type: research
A Standardized Ten-Step Approach to the Sizing and Planning of a Fenestrated Endovascular Aortic Aneurysm Repair
Fenestrated endovascular aneurysm repair (EVAR) is now a Food and Drug Administration-approved treatment in the United States for short-neck infrarenal aortic aneurysms and for juxtarenal aortic aneurysms. Fenestrated EVAR repairs necessitate more involved sizing and planning than does standard EVAR. Sizing and planning of fenestrated cases can often appear overly complicated and intimidating and act as a barrier to physicians interested in learning these techniques. This video describes a standardized 10-step approach to the sizing and planning of a fenestrated endovascular aortic aneurysm repair.
Source: Journal of Vascular Surgery - September 22, 2016 Category: Surgery Authors: Andres Schanzer, Jessica Simons, Francesco Aiello, Danielle Doucet, Robert Steppacher, Elias Arous, Louis Messina Tags: Abstract from the 2016 New England Society for Vascular Surgery Annual Meeting Source Type: research
Vascular Solutions, Inc. Issues Recall of Twin-Pass & reg; Dual Access Catheters
On September 16, 2016, Vascular Solutions, Inc. (Nasdaq:VASC), initiated a nationwide recall of Twin-Pass Dual Access catheters used in catheterization procedures. All unexpired lots of the product have been recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death. No injuries have been reported in association with this issue to date.
Source: Food and Drug Administration - October 4, 2016 Category: Food Science Source Type: news
Map of drugs reveals uncharted waters in search for new treatments
(Institute of Cancer Research) Scientists have created a map of all 1,578 licensed drugs and their mechanisms of action -- as a means of identifying 'uncharted waters' in the search for future treatments. Their analysis of drugs licensed through the Food and Drug Administration reveals that 667 separate proteins in the human body have had drugs developed against them -- just an estimated 3.5 percent of the 20,000 human proteins.
Source: EurekAlert! - Medicine and Health - December 2, 2016 Category: Global & Universal Source Type: news
Long-Term Results of Endovascular Repair for Descending Thoracic Aortic Aneurysms
Since thoracic endovascular aortic repair (TEVAR) received US Food and Drug Administration approval for the treatment of descending thoracic aneurysms in March 2005, excellent 30-day and midterm outcomes have been described. However, data on long-term outcomes is lacking with Medicare data suggesting that TEVAR has worse late survival compared with open descending repair. As such, the purpose of this study was to examine the long-term outcomes for on-label use of TEVAR for repair of descending thoracic aneurysm.
Source: Journal of Vascular Surgery - December 20, 2016 Category: Surgery Authors: David N. Ranney, Morgan L. Cox, Babatunde Yerokun, Ehsan Benrashid, Richard L. McCann, G. Chad Hughes Tags: Abstract from the 2017 Southern Association for Vascular Surgery Annual Meeting Source Type: research
An International Vascular Registry Infrastructure for Medical Device Evaluation and Surveillance
The Medical Device Epidemiology Network (MDEpiNet) is an innovative effort supported by the US Food and Drug Administration (FDA) that is committed to the development of a medical device science and surveillance infrastructure. Recently MDEpiNet sponsored a national medical device registry task force which developed a guidance document for 21st century medical device evaluation that highlights the importance of national and international registries, their linkages with other relevant data, and stakeholder involvement.
Source: European Journal of Vascular and Endovascular Surgery - February 12, 2017 Category: Surgery Authors: A. Sedrakyan, J.L. Cronenwett, M. Venermo, L. Kraiss, D. Marinac-Dabic, M. Bj örck Tags: Special Communication Source Type: research
An international vascular registry infrastructure for medical device evaluation and surveillance †
The Medical Device Epidemiology Network (MDEpiNet) is an innovative effort supported by the US Food and Drug Administration (FDA) that is committed to the development of a medical device science and surveillance infrastructure. Recently MDEpiNet sponsored a national medical device registry task force which developed a guidance document for 21st century medical device evaluation that highlights the importance of national and international registries, their linkages with other relevant data, and stakeholder involvement.
Source: Journal of Vascular Surgery - February 16, 2017 Category: Surgery Authors: Art Sedrakyan, Jack L. Cronenwett, Maarit Venermo, Larry Kraiss, Danica Marinac-Dabic, Martin Bj örck Tags: Special communication Source Type: research
Montelukast inhibits oxidized low-density lipoproteins (ox-LDL) induced vascular endothelial attachment: An implication for the treatment of atherosclerosis.
Abstract
Recruitment of monocytes to endothelial cells is important during early stages of atherosclerosis development, which is activated in response to a number of inflammatory stimuli, including oxidized low-density lipoprotein (ox-LDL). Montelukast is a licensed drug approved by the Food and Drug Administration (FDA) and clinically used for the treatment of asthma by reducing the eosinophilic inflammation in the airway. Little information regarding the effects of Montelukast on endothelial inflammation has been reported before. In the current study, we found that Montelukast markedly reduced ox-LDL-induced mon...
Source: Biochemical and Biophysical Research communications - February 24, 2017 Category: Biochemistry Authors: Di X, Tang X, Di X Tags: Biochem Biophys Res Commun Source Type: research
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA ’s Adverse Event Reporting System (FAERS) and new search tool
Source: Food and Drug Administration - October 2, 2017 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA ’ s Adverse Event Reporting System (FAERS) and new search tool
Source: Food and Drug Administration - October 2, 2017 Category: American Health Source Type: news
Use of Dexmedetomidine in Cardiothoracic and Vascular Anesthesia
Dexmedetomidine is a highly selective α2-adrenergic agonist with analgesic and sedative properties. In the United States, the Food and Drug Administration approved the use of the drug for short-lasting sedation (24 h) in intensive care units (ICUs) in patients undergoing mechanical ventilation and endotracheal intubation. In October 20 08, the Food and Drug Administration extended use of the drug for the sedation of nonintubated patients before and during surgical and nonsurgical procedures.In the European Union, the European Medicine Agency approved the use of dexmedetomidine in September 2011 with a single recognized in...
Source: Journal of Cardiothoracic and Vascular Anesthesia - January 8, 2018 Category: Anesthesiology Authors: Luc ía Gallego-Ligorit, Marc Vives, Jorge Vallés-Torres, T. Alberto Sanjuán-Villarreal, Azucena Pajares, Mario Iglesias Tags: Review Article Source Type: research
FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients
Source: Food and Drug Administration - June 22, 2018 Category: American Health Source Type: news
NESVS11. Fenestrated Endovascular Aneurysm Repair Is Associated With Lower Perioperative Morbidity and Mortality Compared with Open Juxtarenal Aneurysm Repair
The Zenith fenestrated endograft (ZFEN; Cook Medical, Bloomington, Ind) received Food and Drug Administration approval in 2012 for treatment of juxtarenal aortic aneurysms (JAAs). Current data on ZFEN mainly consist of single-institution experience. Therefore, we compared perioperative outcomes after repair using ZFEN with outcomes after open JAA repair and infrarenal endovascular aneurysm repair (EVAR) in a nationwide multicenter registry.
Source: Journal of Vascular Surgery - September 20, 2018 Category: Surgery Authors: Rens R.B. Varkevisser, Thomas F.X. O ’Donnell, Nicholas J. Swerdlow, Patric Liang, Chun Li, Klaas H.J. Ultee, Alexander B. Pothof, Hence J.M. Verhagen, Marc L. Schermerhorn Tags: Abstract from the 2018 New England Society for Vascular Surgery Annual Meeting Source Type: research
Amsel Medical wins FDA nod for Endo Occluder
Amsel Medical said today that it won FDA 510(k) clearance for its Amsel Endo Occluder device intended for occluding blood vessels during endoscopic procedures.
The Cambridge, Mass.-based company touted that the clearance is the third the company has received from the FDA so far for its portfolio of occluder devices.
The Amsel Endo Occluder is a mechanical occlusion clip delivered through a fine needle intended to be deployed to transfix a target vessel while clamping it shut. The device is composed of an endoscopic litigating clip applier and clips which the company said are intended or use on tubular structures or vessel...
Source: Mass Device - November 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Featured Regulatory/Compliance Vascular amselmedical Source Type: news
