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Search Results for abdominal aortic aneurysm
When women are PIs: A story foretold on the vascular frontlines
“Multifactorial” issues persist in gender representation in vascular leadership and trial enrollment, leading women vascular surgeons tell Vascular Specialist. “We would have fewer untoward side effects, fewer drugs removed from the market by the FDA [Food and Drug Administration], and,…
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…
‘FDA’s mission to bring safe and effective vascular surgery devices to market remains steadfast’
The Vascular and Endovascular Devices Team (VEDT) in the Food and Drug Administration (FDA) Office of Cardiovascular Devices appreciates the Vascular Specialist editorial board’s offer to provide an update to the vascular community to enhance regulatory transparency and communication. In…
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…
SVS mourns death of Past President Kenneth Wayne Johnston
The Society for Vascular Surgery (SVS) mourns the death of Kenneth Wayne Johnston, an SVS member, former president and recipient in 2009 of the SVS’ highest honor, the Lifetime Achievement Award. Barry Rubin, MD, chair and program medical director for…
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…