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‘Historical’ CREST-2 data show reduced stroke risk with carotid stenting versus medical therapy alone
The international CREST-2 study has found that, for people with severe carotid artery narrowing who have not experienced recent stroke symptoms, a minimally invasive carotid artery stenting (CAS) procedure—combined with intensive medical therapy—significantly lowered stroke risk compared with medical therapy…
Atherectomy in PAD: Meta-analysis of ‘extensive’ published literature supports use in ‘appropriately selected’ patients
A systematic review and meta-analysis of more than 300 original investigations on atherectomy in peripheral arterial disease (PAD) highlights “overall favorable” clinical outcomes. This and other findings from what researchers say is the first investigation to provide a “comprehensive” overview…
Terumo Aortic announces launch of Fenestrated Treo pivotal IDE study in US
Terumo Aortic today announced enrollment of the first patient in the Fenestrated Treo pivotal investigational device exemption (IDE) study in the U.S. This study is designed to evaluate the endovascular repair of juxtarenal and suprarenal aortic aneurysms using the Fenestrated…
‘We need to look at the totality of evidence’: VIVA panelists examine SWEDEPAD findings
A focused session at the 2025 Vascular Interventional Advances (VIVA) conference (2–5 November, Las Vegas, USA) homed in on the latest findings from the SWEDEPAD registry-based randomized controlled trials (RCTs), with panelists discussing the results with reference to the wider…
RapidAI earns US FDA clearance for AI-driven aortic measurement and surveillance product
RapidAI today announced the US Food and Drug Administration (FDA) clearance of Aortic Management, part of Rapid Aortic, which the company describes as “a comprehensive deep clinical AI [artificial intelligence] solution designed to transform the acute assessment and longitudinal management…
Chronic venous insufficiency: Appeal over ‘not-approvable’ VenoValve fails
enVVeno Medical has announced that it received an “unfavorable” decision from the Food & Drug Administration (FDA) in response to its supervisory appeal of the “not-approvable” letter it received on Aug. 19 in response to its premarket approval (PMA) application…
enVVeno receives ‘unfavorable’ appeal decision from FDA for VenoValve device
enVVeno Medical has announced that it has received an “unfavorable” decision from the Food & Drug Administration (FDA) in response to its supervisory appeal of the not-approvable letter it received on Aug. 19 in response to its premarket approval (PMA)…
ViTAA Medical announces FDA 510(k) clearance for aortic planning platform
ViTAA Medical today announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for AiORTA Plan, which the company describes as a “fully automated, hyper-precise aortic surgery planning solution”. The tool aims to automate key preoperative measurements and…
Elucid launches PlaqueIQ image analysis software for carotid arteries
Elucid has announced the launch of its PlaqueIQ image analysis software for the quantification and classification of plaque morphology in the carotid arteries. According to the company, as the “first and only” computed tomography (CT)-based plaque analysis software indicated for the…
PROMISE III: Six-month data ‘reinforce’ case for TADV in no-option CLTI patients
Six-month outcomes among no-option chronic limb-threatening ischemia (CLTI) patients treated using transcatheter arterialization of the deep veins with the LimFlow system (Stryker/Inari Medical) in the PROMISE III trial showed a 81% rate of amputation-free survival. Principal investigator Daniel Clair, MD,…