Tag: Endologix
Endologix initiates postmarket study of the Detour system
Endologix has announced the initiation of the Percutaneous transmural arterial bypass (PTAB)1 postmarket study. This study marks the beginning of a comprehensive postmarket study...
Centers for Medicare & Medicaid Services grants Transitional Pass-Through payment for...
Endologix recently announced that the Centers for Medicare & Medicaid Services (CMS) has granted a Transitional Pass-Through (TPT) payment for the Detour system, effective...
DETOUR1 and DETOUR2 pooled analysis of bypass system reveals primary rate...
Endologix has announced results from a pooled analysis of the DETOUR1 and DETOUR2 studies evaluating percutaneous transmural arterial bypass (PTAB) with the Detour system.
The Detour system...
Endologix announces first patients treated with the Detour system
Endologix has shared in a press release that the first patients underwent percutaneous transmural arterial bypass (PTAB) using the Detour system since Food and Drug...
Five-year results of the LEOPARD trial published in the Journal of...
Endologix has announced the online publication of the final five-year results of the LEOPARD trial in the Journal of Vascular Surgery (JVS). The study's...
The top 10 most popular Vascular Specialist stories of December 2022
Among the most-read Vascular Specialist stories in December 2022 were the promising results from a postmarket surveillance study of a paclitaxel DCB; the Society...
ESVS AAA guidelines alert recommends ‘enhanced surveillance’ in patients treated with...
In a newly released “focused update” to their 2019 recommendations, the European Society for Vascular Surgery (ESVS) abdominal aortic aneurysm (AAA) guidelines writing committee...
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...
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,...
FDA issues updated safety communication on use of Endologix AFX endovascular...
The Food and Drug Administration (FDA) has issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes...
Endologix announces completion of enrollment in TORUS 2 study for PAD...
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...
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...
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...
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...
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...
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...
Plans revealed for pilot study on performance of EVAR for AAA...
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)...
PAD: Endologix acquires PQ Bypass
Endologix recently announced completing the acquisition of PQ Bypass, a medical technology company pioneering a first-of-its-kind technology that addresses severe peripheral arterial disease (PAD).
PQ...
Endologix enters into agreement with Deerfield Partners to take company private
Endologix has announced that, after evaluating a variety of strategic options, it has initiated a voluntary Chapter 11 case and simultaneously filed a consensual...