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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 the pivotal study. The investigational ZFEN+ clinical study is being conducted under an Investigational Device Exemption…
FDA grants approval for IDE study on Advance Evero 18 everolimus-coated balloon catheter
The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Advance Evero 18 everolimus-coated percutaneous transluminal angioplasty (PTA) balloon catheter, the company reported today. The clinical study…
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 now available as a bridging stent for the treatment of patients with aneurysmal disease. Getinge states…
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) approval as an endovascular treatment option for aortoiliac or iliac aneurysmal disease. The company has also…
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 in serious injury or death. The recall, identified as the most serious type by the Food…
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, earlier this year, cardiothoracic surgeon François Dagenais, MD, from the Quebec Heart and Lung Institute…
Survey of off-label treatment of complex repair pinpoints factors behind underreported outcomes data
The potential for cost and time to be key factors in low levels of outcomes data reporting emerged during a national survey of the off-label use of approved endovascular devices for complex aortic aneurysm repair. Grayson S. Pitcher, MD, an…
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 iCast (Getinge) covered stent for the treatment of aortoiliac aneurysms and preservation of hypogastric artery perfusion,…
Getinge and Cook Medical enter US commercial distribution agreement for iCast covered stent
Getinge and Cook Medical today announced an exclusive sales and distribution agreement for the iCast covered stent system, which recently received Food and Drug Administration (FDA) premarket approval for the treatment of symptomatic iliac arterial occlusive disease. Cook Medical will…
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 Bentley product in the coming months. The BeBack device is designed for steering through chronic total…