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International Study Evaluates Cook Medical's Zenith Alpha TEVAR Device

August 11, 2015—Karl A. Illig, MD, et al published 1-year outcomes from a study evaluating the safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical) for the treatment of descending thoracic aortic aneurysms and large ulcers. The investigators concluded that early outcomes after Zenith Alpha implantation appear promising and suggest expanded thoracic endovascular aortic repair applicability in patients with smaller access vessels. They advised that longer-term follow-up is ongoing. The study is available online ahead of print in the Journal of Vascular Surgery.   According to the investigators, the Zenith Alpha device, with a 16- to 20-F delivery system, was developed to address vascular access issues associated with larger-profile devices and to increase conformability in tortuous anatomy. 

SVS Announces New Reporting Standards for Thoracic Outlet Syndrome

August 23, 2016—The Society for Vascular Surgery (SVS) announced the publication of new reporting standards for thoracic outlet syndrome (TOS) by Karl A. Illig, MD, et al in the Journal of Vascular Surgery (2016;64:797–802). A committee of vascular surgeons appointed by SVS and chaired by Dr. Illig and Audra Duncan, MD, produced the standards, which were developed over 3 years. 

FDA Clears Simbionix Rehearsal Studio Software

September 29, 2010—Simbionix Ltd. (Cleveland, OH) announced the receipt of US Food and Drug Administration clearance for the Procedure Rehearsal Studio software.

Xeltis Receives FDA Breakthrough Device Designation for aXess Vascular Access Conduit, Begins US Pivotal Trial

November 19, 2024—Xeltis recently announced that the FDA has granted Breakthrough Device designation for the company’s aXess vascular access conduit and that the first patient was enrolled in the aXess staged pivotal trial in the United States.

FDA Approves Cook's Zenith Alpha Thoracic Graft

September 17, 2015—Cook Medical announced that the US Food and Drug Administration has approved the company’s lower-profile Zenith Alpha thoracic endovascular graft for the treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair.