Brought to you by:
FDA clears AAA-SHAPE trial for IDE approval
Shape Memory Medical recently announced that the Food and Drug Administration (FDA) has granted investigational device exemption (IDE) for the company to begin a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to…
First US patient enrolled in SOCRATES short neck AAA trial
The first U.S. patient has been treated as part of the SOCRATES trial (Short neck AAA randomized trial—ESAR and FEVAR), which compares the safety and performance of endosuture aneurysm repair (ESAR) with fenestrated endovascular aneurysm repair (FEVAR) for the treatment…
Endovascular stablization system for infrarenal AAAs gains FDA Fast Track designation
Nectero Medical announced that the Food and Drug Administration (FDA) has granted Fast Track designation for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST) system to treat patients with infrarenal abdominal aortic aneurysms (AAAs) of maximum diameter 3.5–5cm. The company…
New study reports positive performance of AI-powered assessment of biomarkers for growth prediction of AAAs
The characterization of aortic tissue by means of three key biomechanics-based biomarkers bundled into a compound Regional Areas of Weakness (RAW) Map showed “very good performance” as part of an artificial intelligence (AI)-based prediction of faster than average growth for…
Nectero Medical receives FDA clearance of IND application to initiate Phase II/III clinical trial of Nectero EAST system
Nectero Medical today announced that the US Food and Drug Administration (FDA) has granted investigational new drug (IND) clearance for the company to initiate a prospective, multicentre, randomised clinical trial (the stAAAble study) to evaluate the safety and efficacy of…
FDA approves study of ZFEN+ for treatment of aortic aneurysms
The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Zenith fenestrated+ endovascular graft (ZFEN+). The clinical study will assess the safety and effectiveness of the ZFEN+ in…
Bias and the silver bullet: Gender partiality seen within AI algorithms for AAA identification
Artificial intelligence (AI) has become a central focus within various spheres, from commerce to medicine—including applications in patient care. Sharon Kiang, MD, talks to Vascular Specialist about the specter of bias and how a “hybrid” approach between AI and human…
Novel drug candidate for slowing AAA growth demonstrates safety in humans
The local delivery of a glucose-derived compound in small- and medium-sized abdominal aortic aneurysms (AAAs) has been deemed safe, with “promising” early efficacy data indicating its potential in stabilising or slowing AAA sac growth. According to Stephen Cheng, MBBS, MS,…
Prediction model offers new option for forecasting AAA growth
A predictive model incorporating 3D shape features such as aneurysmal flow lumen and outer wall structure extracted from computed tomography (CT) imaging can improve the ability to predict the growth of abdominal aortic aneurysms (AAAs). This is according to research…
Five-year results of the LEOPARD trial published in the Journal of Vascular Surgery
Endologix has announced the online publication of the final five-year results of the LEOPARD trial in the Journal of Vascular Surgery (JVS). The study’s findings showed that there was no significant difference in aneurysm-related outcomes between patients randomized to the…