Endologix Provides Update of Ventana Fenestrated System Program

July 1, 2013—Endologix, Inc. (Irvine, CA) announced it has completed an initial evaluation of its Ventana clinical trial in the United States that was suspended earlier this year.

On April 30, the company advised that it would temporarily suspend enrollment in the Ventana clinical trial to evaluate a higher-than-expected number of reinterventions in the trial. Ventana is being conducted in the United States under an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to evaluate the Ventana fenestrated stent graft system for the endovascular repair of juxtarenal and pararenal aortic aneurysms. At that time, the company also stated it would delay the limited market introduction of the Ventana system in Europe.

Endologix stated that this initial evaluation has been completed and that training and design enhancements have been identified that are expected to reduce the reintervention rate and improve clinical outcomes. The company stated that it will conduct testing to validate these design enhancements, and it will meet with regulatory agencies to determine the requirements and commercialization timelines.

Accordingly, Endologix does not anticipate that it will restart enrollment in the Ventana United States IDE clinical trial or begin the limited market introduction of Ventana in Europe before the end of 2013.

Commencement of Ventana's enrollment under the direction of National Principal Investigator Daniel G. Clair, MD, was announced in January 2012.