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The device is being updated, and the new version will be re-submitted for approval.
September 7, 2012
By: Niki Arrowsmith
NULL
Endologix Inc. has been granted European approval to market the current version of the Nellix EndoVascular Aneurysm Sealing System for the treatment of patients with abdominal aortic aneurysms (AAAs). Nellix is an endovascular aneurysm sealing system designed to simplify endovascular procedures, treat a broader range of patients, and provide enhanced clinical outcomes. The Nellix System is not approved in the United States for either investigational use or commercial sale. Endologix currently is implementing a few enhancements to the Nellix System intended to further optimize the device for commercialization. When complete, the company intends to submit these enhancements to its notified body to gain CE Mark approval for the new commercial version of the device and begin a limited market introduction of the enhanced system in Europe by the end of the second quarter 2013. “Nellix has the potential to treat more AAA patients and get better clinical outcomes than any other device for the endovascular repair of AAA,” said John McDermott, company president and CEO. “Receiving CE Mark for the current version of the system is an important regulatory milestone and we look forward to providing this ground-breaking technology to physicians and their patients in 2013.” Endologix is based in Irvine, Calif., and develops and manufactures minimally invasive treatments for aortic disorders.
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