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Endologix receives FDA approval of PMA supplement for AFX2 system
Endologix recently announced that it has received Food and Drug Administration (FDA) approval for a premarket approval (PMA) supplement relating to the AFX2 system. According to a company press release, Endologix received approval to include an updated warning and the…
FDA advisory panel issues recommendations on lifelong surveillance for EVAR
The Food and Drug Administration (FDA) recently announced it has issued a letter to healthcare providers emphasizing the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aneurysm repair (EVAR). “Regular imaging surveillance, within 30-days…
FDA issues updated safety communication on use of Endologix AFX endovascular grafts
The Food and Drug Administration (FDA) has issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes a summary of information from a November 2021 meeting of the FDA’s Circulatory System Devices Panel of…
Endologix announces completion of enrollment in TORUS 2 study for PAD in SFA
Endologix has completed enrollment in the TORUS 2 investigational device exemption (IDE) clinical study in the U.S., a press release reports. The TORUS 2 study is a prospective, single-arm trial of 188 patients to evaluate safety and effectiveness of the Torus stent…
VEITH 2021: Two-year follow-up data from EVAS2 IDE study delivered
The confirmatory EVAS2 clinical study to evaluate the safety and effectiveness of Endologix’s Nellix endovascular aneurysm sealing system (EVAS) for the treatment of infrarenal abdominal aortic aneurysms (AAAs) contains positive two-year follow-up data, the leading investigator has revealed. A first…
Endologix launches randomized study of Alto EVAR device
Endologix today announced that the first patient has been enrolled in the company’s JAGUAR study to compare outcomes for the company’s Alto abdominal stent graft system to other commercially available endovascular aneurysm repair (EVAR) devices for the treatment of abdominal…
The top 10 most popular Vascular Specialist stories in July
The digital version of our July 2021 print issue, an argument in favor of a multidisciplinary approach to limb salvage and look back at the career of a former Society for Vascular Surgery (SVS) president were among the most-read stories…
Endologix receives FDA Breakthrough Device designation for ChEVAS system
Endologix announced the company’s ChEVAS (chimney endovascular aneurysm sealing) system has been granted a Breakthrough Device designation from the Food and Drug Administration (FDA). The ChEVAS system is an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy designed to combine the Nellix 3.5 endograft…
Endologix announces launch of Alto abdominal stent graft in Canada
Endologix today announced the first implant of its Alto abdominal stent graft in Canada following recent approval from Health Canada. Alto was also recently approved for commercial sale in Argentina. The company heralds the Alto abdominal stent graft system as…
Plans revealed for pilot study on performance of EVAR for AAA in office-based labs
Details of a planned pilot study investigating the merits of performing endovascular aortic repair (EVAR) on abdominal aortic aneurysms (AAAs) in office-based labs (OBLs) and other free-standing ambulatory facilities emerged during the recent Critical Issues America annual meeting (April 16–17)…