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Provides Update on New Product Pipeline Including Enhancements to Ventana Program That Will Delay IDE Enrollment and Limited Market Introduction in Europe
Reiterates 2013 Financial Guidance
IRVINE, Calif., April 30, 2013 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, today announced financial results for the three months ended March 31, 2013 and provided an update on the company's new product pipeline.
John McDermott, Endologix President and Chief Executive Officer, said, "We are very pleased with our sales growth in the U.S. and international markets in the first quarter 2013, driven by continued adoption of the AFX® Endovascular AAA System. In Europe, we began the limited market introduction of the Nellix® EndoVascular Aneurysm Sealing System and have received very positive physician feedback on its ease-of-use and clinical outcomes from these first commercial procedures. In addition, we recently received FDA approval for our percutaneous EVAR (PEVAR) indication with AFX and have physician training courses scheduled to begin in May. After our first 120 procedures with the Ventana™ Fenestrated System, we have seen good overall safety results, but a higher than expected number of renal re-interventions. Before we continue enrolling patients in the IDE clinical study and begin the EU limited introduction, we plan to integrate our next generation covered renal stent and conduct additional testing and training to optimize future outcomes. We hope to begin enrolling patients in the study again and start the limited market introduction in Europe by the end of this year."
Mr. McDermott concluded, "Despite the temporary delay in the Ventana program, we are reiterating our guidance for the year based on the strong performance trends in our core business. We continue to believe Ventana represents a significant new innovation in the treatment of juxta and para-renal aortic aneurysms, with the potential to expand the addressable EVAR market. In addition, the limited market introduction of Nellix is going extremely well and we hope to begin enrolling patients in the U.S. IDE by the end of this year".