Tag: Nellix

Endologix Receives IDE Approval for the Nellix Chimney EndoVascular Aneurysm Sealing Protocol

IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption (“IDE”) approval from the United States Food and Drug Administration (“FDA”) to commence a new pivotal study to evaluate the safety and effectiveness of the Nellix Chimney EndoVascular Aneurysm Sealing System […]

Endologix Provides Update on Previously Announced Voluntary Nellix System Recall

IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that the EC Certificate of Conformity (CE Mark) for the Nellix EndoVascular Aneurysm Sealing System (Nellix System) has been suspended by its Notified Body, GMED, following a voluntary recall and Field Safety Notification (FSN) issued by Endologix […]

Endovascular Aneurysm Sealing (EVAS) with Nellix System Associated with Higher Survival than Traditional Endovascular Aneurysm Repair (EVAR) in New Study

IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced the results of a study, which was presented by Marc Schermerhorn, M.D., Chief of Vascular Surgery at Beth Israel Deaconess Medical Center, on the podium at the Late-Breaking Aortic Trials Session during the Charing Cross (CX) 40th International […]

Endologix, Inc. Announces Enrollment of the First Patient in EVAS2 IDE Clinical Study of the Nellix® EndoVascular Aneurysm Sealing System

IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that the first patient was treated in the EVAS2 IDE Confirmatory Clinical Study of the investigational Nellix® EndoVascular Aneurysm Sealing (EVAS) System by Sajjad M. Hussain, M.D., Chief of the Department of Vascular Surgery at St. Vincent Health and […]

Endologix Announces CE Mark Approval For The Nellix Endovascular Aneurysm Sealing System With The Refined Indications For Use

9/21/2017 7:24:55 AM IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (NASDAQ: ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced the CE Mark approval for its Nellix® EndoVascular Aneurysm Sealing System (“Nellix”) with the refined Indications for Use (IFU). Nellix is being studied in the U.S. under an Investigational Device Exemption (IDE). Following a thorough […]

Endologix To Host An Investor Conference Call To Discuss Its Nellix Endovascular Aneurysm Sealing System Presentation At The Society Of Vascular Surgery Annual Meeting On June 3, 2017

IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced that Dr. Jeffrey Carpenter’s submission “Refinement of the IFU for the Nellix® System for Endovascular Aneurysm Sealing Based Upon Outcomes From the EVAS FORWARD IDE Trial” has been accepted for a plenary presentation at the Society of […]