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Viabahn VBX stent graft receives FDA approval
Gore has announced recent Food and Drug Administration (FDA) approval of a lower profile Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) for the treatment of complex iliac occlusive disease. “Our team is pleased to be the first commercial implanter of…
First patient treated in ARISE II study of ascending stent graft
Gore has announced the first patient implantation of the company’s ascending stent graft in the ARISE II trial, describing this as an exciting step in the development of treatments for pathologies involving the ascending aorta using endovascular repair rather than…
Humacyte submits Biologics License Application to FDA seeking approval of Human Acellular Vessel
Humacyte today announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not…
VOYAGER PAD analyses shed light on use of rivaroxaban in high-risk patient populations
New analyses from the VOYAGER PAD clinical trial in both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD) were presented at the American Heart Association (AHA) 2023 Scientific Sessions (Nov. 11–13) in Philadelphia. The…
TCT 2023: First presentation of complete patient-level dataset on paclitaxel and death that helped sway the FDA
Data from a patient-level meta-analysis—a factor in the Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD)—have been made public for the first time at TCT 2023 (Oct.…
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…
VasQ AVF creation device receives FDA clearance
Laminate Medical Technologies has announced their flagship device, the VasQ external vascular support, has been cleared by the Food and Drug Administration (FDA) for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the FDA as…
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…
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…