February’s top 10 includes an update from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on the use of paclitaxel-coated devices for peripheral arterial disease (PAD), a talk delivered at the Critical Issues America (CIA) annual meeting (2–4 February, Miami, USA) on abdominal aortic aneurysm (AAA) and complex repair, and two device updates from Gore.
1. Rijnstate Hospital at the forefront of international research into the treatment of aneurysms
Rijnstate Hospital in Arnhem, The Netherlands, recently announced that the first patient has been enrolled in the HERCULES trial comparing endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR) in the treatment of abdominal aortic aneurysms (AAAs) with wide proximal necks.
2. Gore announces first European implantation of Gore Tag thoracic branch endoprosthesis
Gore has announced the first ever implantation of the Gore Tag thoracic branch endoprosthesis (TBE) in Europe. The patient was treated by Dittmar Böckler, chief of the Department of Vascular Surgery and Endovascular Surgery at University Hospital Heidelberg in Germany.
3. UK MHRA update: Paclitaxel-coated device increased mortality risk is withdrawn for PAD
Following a review, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated guidance on the use of paclitaxel-coated devices stating that such devices can be considered for the treatment of peripheral arterial disease (PAD), including intermittent claudication and critical limb-threatening ischaemia (CLTI).
4. AAA and complex repair: “We need more evidence,” says UChicago chief
A randomised controlled trial (RCT) of open repair versus endovascular aneurysm repair (EVAR) for the treatment of abdominal aortic aneurysms (AAAs), as well as head-to-head trials for additional information on EVAR and complex repairs, are warranted. This was the main conclusion of Ross Milner (Chicago, USA) during a presentation he delivered as part of an ‘EVAR Developments’ session at the recent Critical Issues America (CIA) annual meeting (2–4 February, Miami, USA).
5. Efemoral Medical granted Breakthrough Device designation
Efemoral Medical has announced that the US Food and Drug Administration (FDA) has granted its novel Efemoral vascular scaffold system (EVSS) Breakthrough Device status for the treatment of de novo or restenotic lesions of the infrapopliteal arteries in patients with chronic limb-threatening ischaemia (CLTI).
6. ‘Get a Pulse on PAD’: Multi-society public awareness campaign launched
The multi-society PAD Pulse Alliance is taking part in a peripheral arterial disease (PAD) public awareness campaign called “Get a Pulse on PAD”. The group—formed of the Society for Vascular Surgery (SVS), the Association of Black Cardiologists (ABC), the Society for Cardiovascular Angiography & Interventions (SCAI) and Society of Interventional Radiology (SIR)—aims to educate people on PAD risk factors and potential symptoms, as well as to encourage patients to advocate for their own health with their doctors.
7. Cook Medical reports first patient treated in ZFEN+ fenestrated endovascular graft study
Cook Medical has announced the first patient treated in the clinical study of the Zenith Fenestrated+ endovascular graft (ZFEN+) in the USA. The procedure was performed on 29 January 2024 at The University of Texas Health (UTHealth) in Houston, USA, by Gustavo Oderich, global principal investigator.
Humacyte has announced that the US Food and Drug Administration (FDA) has accepted and granted priority review to Humacyte’s Biologics License Application (BLA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.
9. Measuring plaque inflammation via SCAIL scores may improve carotid stenosis risk stratification
The use of a relatively novel scoring system, referred to as Symptomatic carotid atheroma inflammation lumen-stenosis (SCAIL), has produced favourable predictive qualities versus the Oxford carotid stenosis tool (OCST) and Essen stroke risk score (ESRS). According to researchers, the SCAIL score led to superior recurrent stroke predictions after minor stroke/transient ischaemic attack (TIA) and symptomatic carotid stenosis before revascularisation—as compared to these more established approaches—in a recent study involving three pooled, prospective cohorts of patients.
10. Gore’s Viabahn VBX stent graft receives US FDA approval
Gore has announced recent US Food and Drug Administration (FDA) approval of a lower profile Viabahn VBX balloon expandable endoprosthesis (VBX stent graft). The lower profile device will be rolled out to the US market over the coming months and is also being studied in the TAMBE trial of type 4 thoracoabdominal aortic aneurysms.
