Breakthrough designation for a new drug-eluting stent from Cook Medical, a meta-analysis on the safety of expedited carotid artery surgery vs. expedited stenting after index event, and new aortic and venous guidelines piqued readers’ interest in January.
1. Cook Medical receives FDA breakthrough designation for new drug-eluting stent
Cook Medical received Breakthrough Device designation from the US Food and Drug Administration (FDA) on a new drug-eluting stent for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischaemia (CLTI).
2. FDA issues updated safety communication on use of Endologix AFX endovascular grafts
The US Food and Drug Administration (FDA) issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes a summary of information from a November 2021 meeting of the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee. In addition, the FDA announced that it is providing new recommendations to healthcare providers who treat patients with abdominal aortic aneurysms (AAAs) using the Endologix AFX2 device, the currently available AFX product.
3. Expedited carotid artery surgery after index event “probably safer” than expedited stenting
A systematic review and meta-analysis of 71 studies suggests that, at present, carotid endarterectomy (CEA) is safer than carotid artery stenting (CAS) when performed within two or seven days of the index event. “The findings of this analysis will guide clinical practice when deciding on the type of intervention in the symptomatic patient with severe carotid stenosis,” authors Andreia Coelho (Centro Hospitalar Universitário de Porto, Porto, Portgual) write in the European Journal of Vascular and Endovascular Surgery (EJVES), where the findings were published as an Editor’s choice paper. Coelho et al stress that the ideal timing of performing CAS in symptomatic patients, when indicated against CEA, is not yet defined.
4. New recommendations promote “appropriate and effective” use of social media in medicine
In response to a rapid augmentation of social media use in medicine over the past five years, the Society for Vascular Surgery (SVS) has published a set of recommendations on appropriate practice. The document aims to provide guidance on “how to interact online in a transparent, collegial and ethical manner while all along protecting patient privacy,” Nicolas J Mouawad (McLaren Health System, Bay City, USA) tells Vascular News. In this interview, Mouawad and joint first author Edward D Gifford (Hartford HealthCare, Hartford, USA) outline the paper’s key messages, detail how COVID-19 has “catapulted” the use of virtual communication, and consider how the use of social media in medicine might evolve.
5. Cost-effectiveness of TCAR versus carotid endarterectomy addressed in new study
A cost-effectiveness model based on peer-reviewed sources suggests that although five-year costs for transcarotid artery revascularisation (TCAR; Silk Road Medical) were higher than those for carotid endarterectomy (CEA), TCAR afforded greater quality-adjusted life years (QALY).
6. Medtronic recalls HawkOne directional atherectomy system due to risk of tip damage during use
According to the US Food and Drug Administration (FDA), Medtronic is recalling its HawkOne directional atherectomy system. The FDA has identified the recall as a Class I—the most serious type in that “use of these devices may cause serious injuries or death.” So far, there have been 163 complaints, 55 injuries and no deaths reported in relation to the device issue, the FDA reported.
7. US IDE Aortic Research Consortium “pushes the envelope” on fenestrated and branched procedures
The US investigational device exemption (IDE) Aortic Research Consortium has produced the strongest data so far on the use of fenestrated/branched endovascular aneurysm repair (F/BEVAR), Andres Schanzer (University of Massachusetts, Worcester, USA) claimed at Critical Issues in Aortic Endografting 2021 (17–18 December, Paris, France). As a result of the group’s work, “more patients are getting better care, by more providers, using F/BEVAR devices,” he remarked, summarising key datasets presented since 2018.
8. ISET 2022 audience hears latest data on endovascular therapies
At this year’s International Symposium on Endovascular Therapy (ISET 2022; 16–19 January, Hollywood, USA), experts presented an array of late-breaking trial results on topics ranging from venous stenting to abdominal aortic aneurysm (AAA) sac sealing.
9. Guidelines recognise potential role for earlier endovascular treatment of uncomplicated type B aortic dissection
New clinical practice guidelines have been published, and are intended to act as “guard rails” to determine the treatment options and best practices for managing patients with type B aortic dissection. An important update in the document is the potential for earlier endovascular treatment in patients with uncomplicated type B aortic dissection at higher risk of progressive disease.
10. ESVS publishes 2022 guidelines on management of chronic venous disease of the lower limb
The European Society for Vascular Surgery (ESVS) has released 2022 clinical practice guidelines on the management of chronic venous disease (CVD) of the lower limb to update its 2015 recommendations. The document, authored by Marianne G De Maeseneer (Erasmus Medical Centre, Rotterdam, The Netherlands) and colleagues, was published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).