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Closer to the goal: Shoring up data behind breakthrough imaging technology that plots a radiation-free future in new RCT
UMass chief peers down the lens of an if-not radiation-free complex aortic procedural future, then one in which the methods of today will look positively quaint. “I say this a lot,” says Andres Schanzer, MD, “but I think there is…
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…
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…
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…
MVSS 2025: Gore iliac branch device ‘equally effective’ in both IDE and registry studies
Researchers have reported comparable five-year outcomes of the Gore Excluder iliac branch endoprosthesis (IBE; Gore) in both the investigational device exemption (IDE) and GREAT registry studies of the device. Meghan Barber, MD, a vascular surgery fellow at the University of…
Final patient treated in Cook’s Zenith Fenestrated+ endovascular graft clinical study
Cook Medical has enrolled the final patient in the global clinical study of its Zenith Fenestrated+ endovascular graft (ZFEN+), signifying completion of patient recruitment in the pivotal study. The investigational ZFEN+ clinical study is being conducted under an Investigational Device Exemption…
AI: Where it lands today and how it might impact the vascular future
The speed with which artificial intelligence (AI) is beginning to envelope aspects of the human experience strikes many as jarring. Its entrance into the world of vascular surgery, too, has picked up a pace in recent years, with models and…
‘Critical’ importance of lifelong surveillance after EVAR headlines newly published 10-year ENGAGE data
Ten-year data highlight the long-term efficacy and durability of the Endurant stent graft (Medtronic) in abdominal aortic aneurysm (AAA) patients who survived beyond five years post-enrollment in the ENGAGE registry. However, researchers also draw attention to the incidence of late…
Danish study suggests patients with AAA could benefit from high-dose statin use
A five-year prospective cohort study—using longitudinal registry data from two population-based screening trials—has found that high-dose statin use was associated with decreased abdominal aortic aneurysm (AAA) growth rates and lowered risk of undergoing repair, rupture, and death. Researchers therefore suggest…
From Olympic triumph to healthcare advocacy: Jim Craig to deliver VAM 2025 keynote address
Jim Craig, a longtime support and vascular advocate, will deliver the annual keynote address at the 2025 Vascular Annual Meeting (VAM) in New Orleans (June 4–7). Craig is known as the goaltender for the 1980 U.S. Olympic hockey team and…