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...
Vascular News’ top 10 most popular stories of January 2024
January's top 10 highlights new guidelines from the European Society for Vascular Surgery (ESVS), an expert consensus roundtable on the benefits of intravascular ultrasound...
US Centers for Medicare & Medicaid Services grants Transitional Pass-Through payment...
Endologix recently announced that the US Centers for Medicare & Medicaid Services (CMS) has granted a Transitional Pass-Through (TPT) payment for the Detour system,...
Endologix announces results of pooled analysis of DETOUR1 and DETOUR2 Studies...
Endologix has announced results from a pooled analysis of the DETOUR1 and DETOUR2 studies evaluating percutaneous transmural arterial bypass (PTAB) with the Detour system.
A...
CMS grants New Technology Add-on Payment for Endologix’s Detour system
Endologix has announced that the US Centers for Medicare & Medicaid Services (CMS) recently granted a New Technology Add-on Payment (NTAP) for the Detour...
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 US Food...
Two-year DETOUR2 study results presented at VAM 2023
Endologix has announced the 24-month results of the DETOUR2 study, presented at VAM 2023 (14–17 June, National Harbor, USA), the annual meeting of the...
US FDA approves Endologix’s Detour system for treating complex PAD
Endologix has announced in a press release that the US Food and Drug Administration (FDA) has granted approval for the Detour system to treat...
Endologix announces 150th patient enrolled in JAGUAR randomised controlled trial
Endologix recently announced the completion of the 150th case in the JAGUAR study.
This randomised controlled trial is evaluating Endologix’s Alto abdominal stent graft...
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...
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 US FDA approval of PMA supplement for AFX2 system
Endologix recently announced that it has received US Food and Drug Administration (FDA) approval for a premarket approval (PMA) supplement relating to the AFX2...
Endologix reports five-year data of the LEOPARD trial for the treatment...
Christopher Kwolek (Massachusetts General Hospital and Harvard Medical School, Boston, USA) presented five-year results from the LEOPARD randomised controlled trial (RCT) during a late-breaking...
Endologix submits premarket approval application to FDA for Detour system
Endologix has announced the submission of a premarket approval (PMA) application requesting approval for the Detour system to the US Food and Drug Administration...
Vascular News’ top 10 most popular stories of August 2022
The establishment of the first-ever global consensus for the appropriate use of intravascular ultrasound (IVUS) in lower extremity and arterial and venous interventions, results...
Endologix receives CE mark certification under EU-MDR for AFX2 endovascular AAA...
Endologix recently announced that is has received CE mark certification under the new EU Medical Devices Regulation (EU-MDR) for its AFX2 endovascular abdominal aortic...
Disruptive technology and high-quality clinical evidence: An Endologix transformation
NOTE: This video is ONLY available to watch in selected countries and geographies
Endologix president and CEO, Matt Thompson (Irvine, USA), discusses how the...
FDA advisory panel issues recommendations on lifelong surveillance and long-term postmarket...
The US Food and Drug Administration (FDA) recently announced it has issued a letter to healthcare providers emphasising the importance of lifelong surveillance, including...
Vascular News’ top 10 most popular stories of January 2022
Breakthrough designation for a new drug-eluting stent from Cook Medical, a meta-analysis on the safety of expedited carotid artery surgery vs. expedited stenting after...
FDA issues updated safety communication on use of Endologix AFX endovascular...
Today, the US Food and Drug Administration (FDA) issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes...
Vascular News’ top 10 most popular stories of November 2021
November's top 10 features a large-scale analysis of Philips' intravascular ultrasound (IVUS) in lower extremity peripheral vascular interventions, five-year data on Avenu Medical/Medtronic's Ellipsys...
Endologix announces completion of enrolment in TORUS 2 study for PAD...
Endologix has completed enrolment in the TORUS 2 investigational device exemption (IDE) clinical study in the USA, a press release reports.
The TORUS 2...
VEITH 2021: Two-year follow-up data from EVAS2 IDE study delivered
The confirmatory EVAS2 clinical study to evaluate the safety and effectiveness of the Nellix endovascular aneurysm sealing system (EVAS; Endologix) for the treatment of...
Endologix names Matthew Thompson president and CEO
Endologix has announced the appointment of Matthew Thompson as president and chief executive officer. Thompson will also join Endologix’s board of directors. Richard Mott,...
Endologix initiates randomised study of Alto abdominal stent graft system
Endologix today announced that the first patient has been enrolled in the company’s JAGUAR study to compare outcomes for the Alto abdominal stent graft...
Vascular News’ top 10 most popular stories of July 2021
Updated Society for Vascular Surgery (SVS) clinical practice guidelines on extracranial cerebrovascular disease management and a new meta-analysis on paclitaxel in peripheral arterial disease...
Endologix receives FDA Breakthrough Device designation for ChEVAS system
Endologix today announced the company’s ChEVAS (chimney endovascular aneurysm sealing) system has been granted a Breakthrough Device designation from the US Food and Drug...
Endologix announces launch of Alto abdominal stent graft system 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...
Vascular News’ top 10 most popular stories of April 2021
Highlights from the Charing Cross (CX) 2021 Digital Edition (19–22 April, online)—including the potential of Philips’ Fiber Optic RealShape (FORS) technology to reduce radiation...
Endologix announces acquisition of PQ Bypass
Endologix recently announced it has completed the acquisition of PQ Bypass, a medical technology company pioneering a first-of-its-kind technology that addresses an unmet need...
Endologix launches Alto abdominal stent graft system in Europe
Endologix today announced the first implant of its Alto abdominal stent graft, commencing the European commercial release of the recently CE mark approved endograft.
“We...
Endologix announces first commercial implant of Alto abdominal stent graft system...
Endologix has announced the first implant of its recently approved Alto endograft outside of the USA, completed by Andrew Holden and Andrew Hill of...
Endologix receives CE mark for Alto abdominal stent graft system
Endologix recently announced that it has received a CE mark for the Alto abdominal stent graft system.
“We are very excited to receive a CE...
Endologix announces first commercial implant and US release of Alto abdominal...
Endologix has announced the first commercial implant and the US commercial release of its recently US Food and Drug Administration (FDA)-approved Alto endograft for...
Endologix enters into agreement with Deerfield Partners to take the company...
Endologix has announced that, after evaluating a variety of strategic options, it has initiated a voluntary Chapter 11 case and simultaneously filed a consensual...
Endologix completes enrolment for EVAS2 confirmatory clinical study
Endologix recently announced that it has completed enrolment in the EVAS2 confirmatory clinical study to evaluate the Nellix endovascular aneurysm sealing (EVAS) system.
“The completion...
Endologix receives FDA approval for Alto abdominal stent graft system
Endologix recently announced that it has received approval from the US Food and Drug Administration (FDA) for the Alto abdominal stent graft system (Alto).
The...
High-quality evidence from multiple sources “key” to holistic assessment of endograft...
Matt Thompson (Irvine, USA) talks to VEITHtv about his role, as chief medical officer at Endologix, in assessing the diverse portfolio of endografts and their performance.
Thompson...
LEOPARD trial three-year data provide head-to-head comparison of AFX2 with other...
Christopher Kwolek (Boston, USA) talks to VEITHtv about the “truly revolutionary” LEOPARD trial which evaluated the AFX EVAR AAA Graft System (Endologix) with anatomical fixation against...
Endologix comments on recent FDA update on Type III endoleaks with...
Endologix have announced a response to the US Food and Drug Administration (FDA) update regarding Type III endoleaks with the AFX Endovascular AAA System.
Matt...
CE mark reinstated for Nellix endovascular aneurysm sealing system
Endologix has announced that the CE mark for the Nellix endovascular aneurysm sealing (EVAS) system has been reinstated. The CE mark for the system...
Endologix receives FDA approval for chEVAS IDE study and signs distribution...
Endologix has announced the investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a new pivotal study to...
Endologix announces reinstatement of CE mark for its Nellix endovascular aneurysm...
Endologix recently announced that the EC Certificate of Conformity (CE mark) for the Nellix endovascular aneurysm sealing system (Nellix system) has been reinstated by...
Nellix system CE Mark suspended
The CE Mark for the Nellix endovascular aneurysm sealing system (Endologix) has been suspended by its Notified Body, GMED, following a voluntary recall and...
Unrestricted sales of the Nellix System to cease as use is...
Unrestricted sales and use of the Nellix System (Endologix) will cease immediately, in order to ensure optimal outcomes for patients, according to Endologix. The...
Endologix announces public offering of common stock
Endologix has announced that it has commenced a registered underwritten public offering of US$20 million of its shares of common stock. In addition, Endologix...
Endologix appoints Jeffrey S Brown as chief operations officer
Endologix has announced that it has appointed Jeffrey S Brown as the company’s chief operations officer, effective as of 13 August, 2018.
John Onopchenko, chief...
LUCY one-year results presented at SVS
One-year results from the LUCY (Evaluation of females who are underrepresented candidates for abdominal aortic aneurysm repair) registry were reported at the Society for...
Marc Schermerhorn: Mortality analysis of EVAS vs. EVAR
Marc Schermerhorn (Boston, USA) discusses the three-year results of an analysis on the long-term survival of Nellix EVAS system (Endologix) IDE trial patients vs....
First results of global ENCORE analysis using Ovation abdominal stent graft
The first results have been announced from ENCORE, a pooled, global analysis of several prospective clinical trials and registries studying polymer endovascular aneurysm repair...
EVAS2 IDE clinical study enrols first patient
The first patient has been treated in the EVAS2 IDE confirmatory clinical study of the investigational Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix) by...
Endologix CEO John McDermott steps down
Endologix, a California-based developer and marketer of innovative treatments for aortic disorders, has announced that John McDermott is stepping down as the company’s Chief...
Patient enrolment completed in Endologix’ ELEVATE IDE trial
Endologix, a developer and marketer of treatments for aortic disorders, has announced the completion of enrollment in the ELEVATE (Expanding Patient Applicability with Polymer Sealing...
Endologix appoints John Onopchenko as chief operating officer
Endologix has appointed John Onopchenko as the company's chief operating officer, effective as of 30 October, 2017. Onopchenko will be responsible for managing Endologix's...
FDA grants IDE approval to Endologix for EVAS2 study of Nellix
Endologix has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a confirmatory clinical study (EVAS2) to evaluate the...
Endologix announces collaboration agreements with Japan Lifeline for development and commercialisation...
Endologix has signed a joint research and development agreement, as well as an exclusive distribution agreement, with Japan Lifeline (JLL) pertaining to the development...
Endologix announces positive clinical results from the LEOPARD clinical study
Endologix has announced positive interim results from the LEOPARD (Looking at EVAR outcomes by primary analysis of randomised data) clinical study. LEOPARD is the...
Endologix reports positive clinical data from the Ovation LUCY study in...
Endologix has announced 30-day results from the LUCY (Evaluation of Females who are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair) study. The data showed...
Personalising AAA Care With Polymer Sealing (OUS only)
In this supplement: -The clinical and biological advantages of active sac management with EVAS -10 things to know about Ovation -Ovation: Finally an endograft...
Endologix provides update on the Nellix sealing system US regulatory status
Endologix has met with the US Food and Drug Administration (FDA) regarding its Nellix endovascular aneurysm sealing system (EVAS System).
Based upon that meeting and...
Endologix announces enrolment of first patients in ELEVATE IDE clinical study
Endologix has announced today that the first patients were treated in the ELEVATE (Expanding patient applicability with polymer sealing Ovation Alto stent graft) investigational...
Endologix completes enrolment in Ovation Lucy study
Endologix has completed patient enrolment in the Lucy (Evaluation of females who are underrepresented candidates for abdominal aortic aneurysm repair) study, a multicentre post-market...
Positive three-year results for Endologix Ovation registry presented at LINC 2017
Positive three-year clinical data from the Endologix Ovation European Post Market Registry have been presented at the 2017 Leipzig Interventional Course (LINC; 24-17 January,...
CE mark reinstated for Endologix AFX and AFX2 systems
The CE mark for Endologix’ AFX and AFX2 endovascular abdominal aortic aneurysm systems has been reinstated, effective immediately.
The CE mark was temporarily suspended due...
Endologix resumes shipments of all sizes of AFX2 systems
Endologix has resumed shipments of all sizes of AFX2 endovascular abdominal aortic aneurysm systems. The large diameter sizes of AFX2 were placed on a temporary...
Endologix provides physicians with updated AFX information
Endologix has issued a letter to physicians with updated information about the AFX endovascular abdominal aortic aneurysm system.
The voluntary letter, issued after discussions with...
Australian Therapeutic Goods Administration approves Endologix’ AFX2 bifurcated endograft system
The Australian Therapeutic Goods Administration (TGA) has approved Endologix’ AFX2 bifurcated endograft system for inclusion on the Australian Register of Therapeutic Goods. The TGA...
Andrew Holden: Nellix EVAS Global Forward Registry
Andrew Holden (Auckland City Hospital, Auckland, New Zealand) is one of the principal investigators of the Nellix EVAS FORWARD Global Registry. He explained to...
Matt Thompson: The Endologix portfolio within the physician’s armamentarium
Matt Thompson (Chief Medical Officer, Endologix) speaks to Vascular News about what plans he has in his new role and the place of the...
Bob Mitchell: Latest developments in Nellix EVAS
Speaking to Vascular News at the 2016 VEITHsymposium, Bob Mitchell (President, Endologix) discusses updated Nellix instructions for use and the potential of the endovascular...
Five-year results confirm “long-term safety and durability” of Endologix Ovation system
Clinical data presented at the 2016 VEITH symposium (New York City, USA) of the global Ovation Pivotal Trial has revealed positive five-year safety and...
Endologix’ EVAS FORWARD Global Registry finds positive Nellix outcomes at two...
Data from Endologix' Global Registry have found 98% freedom from persistent endoleaks with its Nellix system at two-year follow-up, among other positive results. The...
Endologix reports positive clinical data from Ovation LIFE study
Endologix has announced positive clinical data from the Ovation LIFE (Least Invasive Fast-Track EVAR) study. Zvonimir Krajcer, co-director, Peripheral Vascular Disease Service at Texas...
First patients treated with Endologix’s Ovation Alto abdominal stent graft system
The first two patients with abdominal aortic aneurysms (AAA) have been treated with Endologix’s Ovation Alto abdominal stent graft system. The patients were treated...
Nellix IDE trial shows low morbidity and mortality with high procedural...
Primary safety and efficacy endpoints for the Nellix system (Endologix) investigational device exemption (IDE) trial have been achieved at one year, with “very low...
