Tag: Nellix
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...
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 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 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...
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...
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...
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...
Positive two-year Endologix Nellix clinical data presented at SVS 2017
Positive two-year clinical data from Endologix’ Nellix EVAS FORWARD investigative device exemption trial have been presented at the Society of Vascular Surgery (SVS; 31...
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...
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...
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...