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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…
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…
Cook Medical treats first patient in first-in-human clinical trial for venous valve
Cook Medical recently announced that the first patient has been treated in a clinical study to evaluate a new venous valve designed for treating chronic venous insufficiency (CVI). The patient was treated by principal investigator Mauricio Alviar, MD, a vascular…
Off-the-shelf branched endograft for TAAAs demonstrates safety and effectiveness through two years in both stable, symptomatic patients
Two-year target vessel-related freedom from all-cause and aneurysm-related mortality for an off-the-shelf multibranched endovascular device for the treatment of thoracoabdominal aortic aneurysms (TAAAs) came in at 78.5% and 98.6%, 2022 Vascular Annual Meeting (VAM) attendees heard. The data relate to…
Cook Medical receives FDA Breakthrough Device designation for Zenith Thoraco+ endovascular system
Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received Breakthrough Device designation from the Food and Drug Administration (FDA), a press release reports. The company details that, while the product is not commercially available yet, the benefits of the designation…
Cook Medical receives FDA breakthrough designation for new drug-eluting stent
Cook Medical has received Breakthrough Device designation from the Food and Drug Administration (FDA) on a new drug-eluting stent (DES) for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischemia (CLTI). The Breakthrough…
Three-year VIVO results back ‘continued safety and effectiveness’ of Zilver Vena venous stent
Three-year results of the VIVO clinical study support the continued safety and effectiveness of the Zilver Vena venous stent (Cook Medical) in the treatment of symptomatic iliofemoral venous outflow obstruction, attendees at the Vascular Interventional Advances (VIVA) 2021 (Oct. 5–7) in Las Vegas.…
Five-year STABLE II results show Zenith system makes the cut for acute complicated TBAD treatment
Joseph V. Lombardi, MD, reported long-term outcomes favoring the continued safety and effectiveness of a composite device (proximal covered stent graft plus distal bare stent) deployed for the endovascular repair of acute, type B aortic dissection (TBAD) complicated by aortic…
FDA grants breakthrough device designation for Zenith fenestrated+ endovascular graft
The Zenith fenestrated+ endovascular graft (ZFEN+) product (Cook Medical) has received breakthrough device designation from the Food and Drug Administration (FDA). This designation is granted for devices that have the potential to provide more effective treatment or diagnosis for life-threatening…
STABLE II results published on endovascular treatment of acute complicated TBAD with Cook Zenith
Thirty-day and one-year data from the STABLE II study have been published in the April 2020 issue of the Journal of Vascular Surgery (JVS) by Joseph V. Lombardi, MD, professor and chief of vascular surgery at Cooper University Hospital, Camden, New Jersey, and…