Tag: Cook Medical
Final patient treated in Cook’s Zenith Fenestrated+ endovascular graft clinical study
Cook Medical has enrolled the final patient in the global clinical study of its Zenith Fenestrated+ endovascular graft (ZFEN+), signifying completion of patient recruitment in...
FDA grants approval for IDE study on Advance Evero 18 everolimus-coated...
The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Advance Evero...
Getinge’s iCast covered stent system approved as bridging stent in US
Getinge recently announced that it has received Food and Drug Administration (FDA) premarket approval (PMA) for the iCast covered stent system. The device is...
Cook announces US launch of Zenith iliac branch device
Cook Medical has announced that its Zenith iliac branch device (ZBIS) is now commercially available in the U.S. with Food and Drug Administration (FDA)...
Cook Medical issues Class I recall for Beacon Tip angiographic catheters
Cook Medical has initiated a Class I recall of its Beacon Tip 5F angiographic catheter.
This follows reports of tip separation that could result...
Cook Medical creates custom-made aortic device for fenestrated FET procedure
Cook Medical this week announced that it has created a custom-made device for the frozen elephant trunk (FET) aortic procedure.
A press release details that,...
Survey of off-label treatment of complex repair pinpoints factors behind underreported...
The potential for cost and time to be key factors in low levels of outcomes data reporting emerged during a national survey of the...
PRESERVE II trial shows robust five-year outcomes
Five-year outcomes the PRESERVE II pivotal trial of Cook Medical’s Zenith branch iliac graft (ZBIS) demonstrate “sustained safety and effectiveness” when combined with the...
Getinge and Cook Medical enter US commercial distribution agreement for iCast...
Getinge and Cook Medical today announced an exclusive sales and distribution agreement for the iCast covered stent system, which recently received Food and Drug...
Bentley, Cook Medical enter US distribution agreement for BeBack device
Cook Medical and Bentley today announced a distribution agreement for the BeBack crossing catheter in the U.S., with Cook assuming commercial responsibilities for the...
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...
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....