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Fluoroquinolones linked to increased incidence of aortic aneurysms in US adults
Fluoroquinolones—one of the most commonly prescribed antibiotic classes in the United States—were associated with increased incidence of aortic aneurysm formation in U.S. adults, a new study published in JAMA (Journal of the American Medical Association) Surgery found. “This association…
FDA representatives respond to SWEDEPAD interim analysis, highlight need for continued study
Representatives from the Food and Drug Administration (FDA) referenced “important and reassuring” results from the recent interim analysis of the SWEDEPAD clinical trial in which patients with peripheral arterial disease (PAD) received treatment with paclitaxel-coated or uncoated endovascular devices. However, writing in…
Vesper Medical announces first enrollment in the VIVID trial
Vesper Medical recently announced initiation of its Food and Drug Administration (FDA) investigational device exemption (IDE) study, VIVID (Venous stent for the iliofemoral vein investigational clinical trial using the Vesper Duo venous stent system). The VIVID trial is a prospective, multicenter, single-arm study to…
Janssen applies to FDA for new indication to expand use of rivaroxaban in PAD patients
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for a new indication to expand the use of Xarelto (rivaroxaban) in patients with…
‘Nearly nothing’ in surgery will go untouched by AI, ACS Clinical Congress hears
Almost nothing will go untouched by artificial intelligence (AI) in healthcare and surgery, notably in the quickly evolving world of vascular and endovascular surgery, Elsie Gyang Ross, MD, told the American College of Surgeons (ACS) Clinical Congress 2020 (Oct. 3–7).…
Vascular surgeons encouraged to consult talking points document on paclitaxel devices
Vascular surgeons are being encouraged to take consideration of a set of talking points about the risks and benefits of paclitaxel-equipped devices—which has been developed by a multispecialty panel of medical societies—in discussions with their patients. The document is the…
Terumo Aortic gains FDA approval for Treo endovascular device
Terumo Aortic has been granted Food and Drug Administration (FDA) approval for the Treo abdominal aortic stent-graft system to be sold in the U.S. The Treo, used in the treatment of patients with abdominal aortic aneurysms (AAA), is the only…
First US commercial use of Tack Endovascular System in BTK arteries announced
Intact Vascular has announced the first commercial use of its Tack Endovascular System (4F) in multiple sites across the United States. Notably the first Food and Drug Administration (FDA)-approved vascular implant for below-the-knee (BTK), post-angioplasty dissection repair, Tack implants are designed…
FDA grants Nexus aortic arch stent graft system breakthrough designation
Endospan was recently granted breakthrough device designation from the Food and Drug Administration (FDA) for the Nexus aortic arch stent graft system. The FDA’s breakthrough device designation program is intended to provide timely access to medical devices that have the…
FDA official delivers government agency’s early reaction to latest contentious meta-analysis on paclitaxel-coated devices
HOLLYWOOD, Fla.—A Food and Drug Administration (FDA) official delivered a talk which represents the government agency’s earliest public reaction to the latest meta-analysis suggesting significantly reduced amputation-free survival at one year when paclitaxel-coated balloons are applied in arteries below the…