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Shape Memory Medical announces midway milestone in AAA-SHAPE randomised controlled pivotal trial
Shape Memory Medical has reached 50 per cent enrolment in its ongoing AAA-SHAPE pivotal trial, the company announced last week. AAA-SHAPE is a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to improve…
Randomized trial finds inferior mesenteric artery embolization ‘may not be effective’ in EVAR
Results from a multicenter randomized controlled trial (RCT) indicate that pre-emptive inferior mesenteric artery (IMA) embolisation during endovascular aneurysm repair (EVAR) does not significantly reduce aneurysm sac volume or rates of type II endoleak. The CLARIFY IMA study—which the authors…
Medtronic’s Endurant receives FDA labelling approval to remove rAAA treatment warning
Medtronic recently announced it has received Food and Drug Administration (FDA) labelling approval for the Endurant stent graft system, by adding ruptured abdominal aortic aneurysm (rAAA) clinical evidence and removing the rAAA treatment warning. A press release notes that this…
EACTS 2025 hears new data on aortic arch remodelling device
Data from the AMDS PERSEVERE and PROTECT trials—both assessing the use of the Ascyrus medical dissection stent (AMDS, Artivion)—were presented in late-breaking science presentations at the 39th European Association for Cardio-Thoracic Surgery (EACTS) annual meeting (8–11 October, Copenhagen, Denmark). The…
Nurea receives US FDA clearance for AI-powered PRAEVAorta 2 software
Nurea’s PRAEVAorta 2 artificial intelligence (AI)-powered software has received US Food and Drug Administration (FDA) 510(k) clearance, a company press release reveals. According to Nurea, PRAEVAorta 2 provides vascular physicians with advanced automated measurement tools for aortic diameters on contrasted…
Non-contrast MRI outperforms DSA in detecting below-the-knee arteries in CLTI patients
Researchers have shown that quiescent-inflow single-shot (QISS) magnetic resonance imaging (MRI) is able to identify more below-the-knee vessel segments than digital subtraction angiography (DSA) in patients with chronic limb-threatening ischaemia (CLTI). Taking first prize for best abstract, Alexander Crichton (Houston…
Sheahan takes over as Vascular Surgery Board chair
Malachi Sheahan III, MD, chair of the Department of Surgery and chief of vascular surgery at Louisiana State University in New Orleans, is the new chair of the Vascular Surgery Board (VSB) of the American Board of Surgery (ABS). Sheahan…
Medtronic fully launches Neuroguard IEP system
Medtronic has announced the full distribution of the Neuroguard integrated embolic protection (IEP) system for carotid artery disease following its limited market distribution, the company announced. This follows the announcement earlier this year of an exclusive U.S. distribution agreement between…
NESVS 2025: Alik Farber takes over as New England Society for Vascular Surgery president
Alik Farber, MD, surgeon-in-chief at Boston Medical Center and James Utley professor and chair of surgery at Boston University Chobanian and Avedisian School of Medicine, is the new president of the New England Society for Vascular Surgery (NESVS). Farber took…
Terumo Aortic and Bentley announce collaboration on US FEVAR study
Terumo Aortic and Bentley today announced their partnership in a clinical study in the USA. The objective is to obtain US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for Terumo Aortic’s fenestrated Treo device, in combination with…