Tag: Cook Medical

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+...

Cook Medical treats first patient in first-in-human clinical trial for venous...

Cook Medical recently announced that the first patient has been treated in a clinical study to evaluate a new venous valve designed for treating...

Off-the-shelf branched endograft for TAAAs demonstrates safety and effectiveness through two...

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...

Cook Medical receives FDA Breakthrough Device designation for Zenith Thoraco+ endovascular...

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...

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...

Three-year VIVO results back ‘continued safety and effectiveness’ of Zilver Vena...

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...

Five-year STABLE II results show Zenith system makes the cut for...

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...

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...

STABLE II results published on endovascular treatment of acute complicated TBAD...

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....