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CE Mark Suspended for Endologix's Nellix System

January 22, 2019—Endologix, Inc. announced that the CE Mark for the Nellix endovascular aneurysm sealing system has been suspended by its Notified Body, GMED, after a voluntary recall and Field Safety Notification (FSN) issued by Endologix on January 4, 2019.

European CE Mark Reinstated for Endologix's Nellix EVAS System

June 6, 2019—Endologix, Inc. announced that CE Mark certification for the company's Nellix endovascular aneurysm sealing (EVAS) system has been reinstated by GMED, the European Union Notified Body for the device, after an assessment of clinical evidence.

Endologix Receives CE Mark for Alto Abdominal Stent Graft System

August 5, 2020—Endologix Inc. announced that the company’s Alto abdominal stent graft system has received CE Mark approval in the European Union (EU) for endovascular aneurysm repair (EVAR) in abdominal aortic aneurysms (AAAs).

Endologix AFX 2 Endovascular AAA System Receives CE Mark Certification Under New EU-MDR

August 4, 2022—Endologix LLC announced that is has received CE Mark certification under the new European Union Medical Devices Regulation (EU-MDR, 2017/745) for the company’s AFX2 endovascular aortic abdominal aneurysm (AAA) system, which integrates anatomical fixation into aortic endografts with an advanced delivery system to treat patients with AAA.

EVAS FORWARD—Global Registry Supports Endologix's Nellix Device

April 29, 2015—Endologix, Inc. announced that updated clinical data from the company’s EVAS FORWARD—Global Registry were presented by Professor Matt Thompson, MD, at the Charing Cross Symposium being held April 28 to May 1 in London, United Kingdom.

ASCEND Data Support Endologix Nellix EVAS System to Treat Juxtarenal and Pararenal AAAs

April 28, 2016—Endologix, Inc. announced the first data presentation from the ASCEND Registry (Aneurysm Study for Complex Abdominal Aortic Aneurysm [AAA]: Evaluation of Nellix Durability), a physician-initiated registry of the Nellix EndoVascular Aneurysm Sealing (EVAS) system used with aortic branch stent grafts for the treatment of patients with complex AAAs. In November, the company announced the start of the registry, which is being conducted outside the United States.

Endologix Completes Enrollment in EVAS FORWARD—GLOBAL Registry of Nellix System

September 29, 2014—Endologix announced that it has completed patient enrollment in the EVAS FORWARD—GLOBAL registry, which enrolled 300 patients treated with the company’s Nellix endovascular aneurysm sealing (EVAS) system at centers in Europe and New Zealand from October 2013 to September 2014.

Physician-Initiated ASCEND Registry to Evaluate the Endologix Nellix EVAS System

November 18, 2015—Endologix, Inc. announced the start of a physician-initiated registry of the Nellix endovascular aneurysm sealing (EVAS) system used with aortic branch stent grafts for the treatment of patients with complex abdominal aortic aneurysms (AAAs).

FDA Approves Indication for Medtronic's Valiant Captivia to Treat Type B Aortic Dissections

January 28, 2014—Medtronic, Inc. (Santa Rosa, CA) announced it has received approval from the US Food and Drug Administration (FDA) for the Valiant Captivia thoracic stent graft system to be used in the treatment of type B aortic dissections.