Endologix (ELGX) Announces Presentation of Nellix EVAS System Post-Market Study Data in AAA Patients
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Endologix, Inc. (NASDAQ: ELGX) announced the presentation of two-year clinical data from the Company's EVAS FORWARD - Global Registry, a post-market study that prospectively enrolled patients with abdominal aortic aneurysms ("AAAs") who were treated with the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System"). Andrew Holden, MD, Associate Professor of Radiology at Auckland City Hospital (Auckland, New Zealand) and one of the principal investigators of the EVAS FORWARD - Global Registry, presented the results at the 2016 VEITH symposium.
The Global Registry data covers a total of 300 patients treated with the Nellix system, enrolled in Europe and New Zealand, with two-year follow-up. Key highlights from the data included:
- 37% of the patients had complex anatomies
- 98% freedom from any persistent endoleaks at latest follow-up
- No secondary interventions for Type II endoleaks
- 97% freedom from aneurysm-related mortality
- 99% freedom from cardiovascular mortality
These data continue to support positive outcomes in a real world patient population that had no screening or anatomical restrictions at enrollment, and constitute the broadest range of aortic anatomies for any prospective endovascular AAA study.
Dr. Holden commented, “The two-year results from the EVAS FORWARD – Global Registry confirm the significant potential for EVAS with Nellix to treat a broad range of patients and provide excellent results, especially within the indications for use. In addition, the continued low rates of aneurysm and cardiovascular-related mortality suggest that EVAS with Nellix may provide additional benefits beyond traditional EVAR.”
John McDermott, Chief Executive Officer of Endologix, said, “We are encouraged by the two-year results from the Nellix EVAS FORWARD – Global Registry and have validated that EVAS with Nellix provides the lowest rates of endoleak of all endovascular AAA technologies. We’d like to thank the study investigators for their ongoing contributions and look forward to initiating Phase 2 of the Registry to include the Nellix Gen2 system and our refined indications, which we expect will provide exceptional clinical outcomes.”
The Nellix EVAS System is a new generation of AAA therapy designed to seal the entire abdominal aortic aneurysm sac. It is the first and only EVAS product and was developed to reduce all types of endoleaks and improve long-term patient outcomes. Nellix is an investigational device in the United States.
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