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‘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,…
PERFORMANCE III demonstrates ‘very low’ 30-day event rates for dual neuroprotection in TCAR
Thirty-day results from the PERFORMANCE III study of integrated embolic protection (IEP) in transcarotid artery revascularization (TCAR) demonstrate “very low” 30-day event rates. Sean Lyden, MD, chair of vascular surgery at the Cleveland Clinic in Cleveland, Ohio, shared this finding…
‘Excellent’ one-year outcomes from ROADSTER 3 show TCAR is ‘safe and effective’
One-year outcomes in the ROADSTER 3 post-approval study to evaluate the safety and effectiveness of transcarotid artery revascularization (TCAR) using the Enroute stent and neuroprotection system (Boston Scientific) in standard-surgical-risk patients revealed a 1.5% intention-to-treat rate of composite major adverse…
One-year results from IVC stent clinical trial show positive safety and efficacy data
Twelve-month results from the clinical trial assessing a dedicated venous stent for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without combined iliofemoral obstruction showed the device exceeded its performance goal for freedom from a composite of…