Enrolment in the investigational device exemption study of the Ventana Fenestrated System has been stopped by Endologix. According to the company, after the first 120 procedures, the safety results with the device were good but there have been a high number of renal re-interventions. Endologix plans to integrate its next-generation covered renal stent in the system and conduct additional testing and training to improve future outcomes. The company also reported 22% revenue growth for the first quarter 2013.
On 30 April 2013, John McDermott, Endologix president and chief executive officer, announced financial results for the three months ended 31 March 2013 and provided an update on the company’s new product pipeline. “We are very pleased with our sales growth in the USA 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 optimise 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.”
McDermott concluded, “Despite the temporary delay in the Ventana programme, 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 US IDE by the end of this year.”
The company’s global revenue in the first quarter of 2013 was US$29.8 million, a 22% increase from US$24.5 million in the first quarter of 2012. US revenue in the first quarter of 2013 was US$24.7 million, a 17% increase compared with US$21.1 million in the first quarter of 2012, which was largely driven by the continued adoption of the AFX system and the expansion of the US sales force through the addition of sales representatives and clinical specialists that exclusively provide field support to our sales representatives, increasing overall sales force productivity. International revenue was US$5.1 million, a 46% increase compared to US$3.5 million in the first quarter of 2012. The international sales increase is primarily attributable to a transition to a direct sales organisation in Europe, beginning in September 2011.