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Survey of off-label treatment of complex repair pinpoints factors behind underreported outcomes data
The potential for cost and time to be key factors in low levels of outcomes data reporting emerged during a national survey of the off-label use of approved endovascular devices for complex aortic aneurysm repair. Grayson S. Pitcher, MD, an…
Vascular community has a role to play in ensuring safety of aortic devices
Physician-sponsored Investigational Device Exemption (IDE) trials have an important role to play in the continued development and refinement of aortic endovascular devices, attendees of a panel session on aortic device regulation heard yesterday. The session, taking place Wednesday lunchtime, set…
Analysis will kickstart conversation on F/BEVAR outcomes
New data presented during Friday’s Plenary Session 6 (10–11 a.m. in the West Building, Skyline Ballroom) will shed light on trends in the adoption of fenestrated and branched endovascular aortic repair (F/BEVAR) outside of Food and Drug Administration (FDA) Investigational…
Getinge and Cook Medical enter US commercial distribution agreement for iCast covered stent
Getinge and Cook Medical today announced an exclusive sales and distribution agreement for the iCast covered stent system, which recently received Food and Drug Administration (FDA) premarket approval for the treatment of symptomatic iliac arterial occlusive disease. Cook Medical will…
Florida IDE trial data support use of physician-modified F/BEVAR over open conversion to treat failed EVAR
This advertorial is sponsored by Tampa General Hospital. As Dean Arnaoutakis, MD, describes it, failed endovascular aortic aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) because of poor proximal fixation of the implanted endograft is a small but increasing problem.…
First patient treated in ZFEN+ fenestrated endovascular graft study
Cook Medical has announced the first patient treated in the clinical study of the Zenith Fenestrated+ endovascular graft (ZFEN+) in the U.S. The procedure was performed on Jan. 29, 2024, at the University of Texas Health (UTHealth) in Houston, Texas, by…
Enrollment complete in APEX-AV study of mechanical aspiration system for acute PE
Patient enrollment is now complete in the APEX-AV trial evaluating the safety and efficacy of the AlphaVac F1885 (AngioDynamics) multipurpose mechanical aspiration system for the treatment of acute intermediate-risk pulmonary embolism (PE). APEX-AV is a single-arm investigational device exemption (IDE)…
Enrollment of first patient in Neuroguard carotid stent system trial announced
Contego Medical has announced enrollment of the first patient in the prospective, multicenter PERFORMANCE III trial aimed at further evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) direct system—a carotid stent system designed for direct transcarotid access. The study is…
Light-activated drug-coated balloon granted FDA approval for clinical study
Alucent Biomedical has announced that the Food and Drug Administration (FDA) granted an investigational device exemption (IDE) for a U.S. clinical study of AlucentNVS, a light-activated, drug-coated balloon catheter technology. AlucentNVS combines an intravascular device with a photochemical process to…
‘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…