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Early adaptation of SVS, STS TBAD joint document will drive robust body of work for comparison
The Society for Vascular Surgery (SVS) and the Society of Thoracic Surgeons (STS) recently published a joint document on reporting standards for type B aortic dissection (TBAD). The purpose of this document was to establish a standardized language for presentation,…
Newly FDA-approved device for central venous occlusions hailed as exciting advance
HOUSTON—These are exciting times in the theater of dialysis access, expert in the field Eric Peden, MD, mused in the latter part of last year—“and that’s not always been easy to say because dialysis has had not too much change…
Deploying robust, detailed SVS VQI data to help better define role of paclitaxel technology in clinical practice
In December 2018, the Journal of the American Heart Association published “Risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the leg: A systematic review and meta‐analysis of randomized controlled trials” by Konstantinos Katsanos…
FDA keeps close watch on heparin dosing reports
The Food and Drug Administration (FDA) is closely monitoring reports of higher than usual doses of heparin being required to achieve activated clotting times (ACT) during cardiac procedures. The FDA “is aware of spontaneous adverse event reports submitted to FDA’s…
SVS president presents point-by-point defense of Society position on paclitaxel controversy
NEW YORK—Kim Hodgson, MD, president of the Society for Vascular Surgery, delivered a robust defense of the SVS position on the drug-coated balloon (DCB) and drug-eluting stent (DES) issue that is currently enveloping the vascular community during the 2019 iteration…
Regulatory unity can help drive medical device adoption globally, FDA official says
LAS VEGAS—Efforts at international collaboration across borders can drive harmony among disparate regulatory requirements and lead to greater global cooperation at the medical device level, a senior member of the Food and Drug Administration (FDA) told the opening session of…