Tag: Endologix

nellix

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...
CE

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

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

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...
nellix

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

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

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...
nellix

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...
nellix

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...