Filtered By:
Management: Food and Drug Administration (FDA)
This page shows you your search results in order of relevance.
Order by Relevance | Date
Total 8017 results found since Jan 2013.
A Vascular Surgeon Plays a Critical Role in the Development of a Successful TAVR Program
Transcatheter aortic valve replacement (TAVR) is a Food and Drug Administration-approved means of treating symptomatic aortic stenosis in high-risk patients. A number of techniques to deliver valve prostheses are currently in practice, including transfemoral (TF), transapical, and transaortic approaches. Various disciplines are involved throughout this complex process. Our team includes a vascular surgeon, bringing greater experience in aortoiliac imaging, vascular access, and repair. We analyzed the role of a vascular surgeon during the selection process and throughout safe device delivery.
Source: Journal of Vascular Surgery - August 22, 2014 Category: Surgery Authors: Jeffrey Ranaudo, Ossama Reslan, Marc Cohen, Bruce Haik, Mark Russo, Paul Burns, Bruce J. Brener, Cindy Sturt Tags: Abstracts from the 2014 New England Society for Vascular Surgery/Eastern Vascular Society Joint Annual Meeting Source Type: research
Tissue Engineering of Vascular Grafts: A Case Report From Bench to Bedside and Back
Arterioscler Thromb Vasc Biol. 2023 Jan 12. doi: 10.1161/ATVBAHA.122.318236. Online ahead of print.ABSTRACTFor over 25 years, our group has used regenerative medicine strategies to develop improved biomaterials for use in congenital heart surgery. Among other applications, we developed a tissue-engineered vascular graft (TEVG) by seeding tubular biodegradable polymeric scaffolds with autologous bone marrow-derived mononuclear cells. Results of our first-in-human study demonstrated feasibility as the TEVG transformed into a living vascular graft having an ability to grow, making it the first engineered graft with growth pot...
Source: Arteriosclerosis, Thrombosis and Vascular Biology - January 12, 2023 Category: Cardiology Authors: Thomas Breuer Michael Jimenez Jay D Humphrey Toshiharu Shinoka Christopher K Breuer Source Type: research
Nonclinical Safety Biomarkers of Drug-induced Vascular Injury: Current Status and Blueprint for the Future.
We describe the mechanisms of these changes and their associations with candidate biomarkers for which advanced analytical method validation was completed. Further development is recommended for circulating microRNAs, endothelial microparticles, and imaging techniques. Recommendations for sample collection and processing, analytical methods, and confirmation of target localization using immunohistochemistry and in situ hybridization are described. The methods described are anticipated to aid in the identification and qualification of translational biomarkers for DIVI.
PMID: 24777748 [PubMed - as supplied by publisher]
Source: Toxicologic Pathology - April 28, 2014 Category: Pathology Authors: Mikaelian I, Cameron M, Dalmas DA, Enerson BE, Gonzalez RJ, Guionaud S, Hoffmann PK, King NM, Lawton MP, Scicchitano MS, Smith HW, Thomas RA, Weaver JL, Zabka TS, and The Vascular Injury Working Group of the Predictive Safety Consortium Tags: Toxicol Pathol Source Type: research
Study finds higher complication risk with Cardinal Health ’ s Mynx vascular closure device
A study published last week in The New England Journal of Medicine concluded that patients treated with Cardinal Health (NYSE:CAH)’s Mynx vascular closure device are at higher risk for vascular complications compared to patients that received alternative vascular closure devices. The data also suggested that patients who received the Mynx device were at greater risk for access site bleeding and transfusion compared to their counterparts.
The team of researchers analyzed data from 73,124 patients who received Mynx devices after percutaneous coronary intervention procedures with femoral access from January 1, 2011...
Source: Mass Device - February 1, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Vascular Wall Street Beat Cardinal Health Source Type: news
Patient-reported outcomes in hemodialysis vascular access: A call to action
J Vasc Access. 2021 May 25:11297298211018295. doi: 10.1177/11297298211018295. Online ahead of print.ABSTRACTWhile access-related dysfunction is a clear driver of clinical outcomes and costs, the full impact of vascular access dysfunction on patient experience and quality of life is not fully characterized in the literature. One way to more comprehensively characterize the patient experience from the patient perspective is through patient reported outcomes (PROs). However, the limited implementation of PROs in clinical trials, patient registries, quality measurement, and other research settings has significantly constrained...
Source: The Journal of Vascular Access - May 25, 2021 Category: Surgery Authors: Karen Woo Robert Fuld Amanda Grandinetti Jeffrey Lawson Terry Litchfield Mark Ohan John Devin Peipert Matthew B Rivara Glenda Roberts Prabir Roy-Chaudhury Margo Underwood Robert J Nordyke Source Type: research
