First Patients Treated With Endologix's Investigational Ovation Alto EVAR System for Complex AAAs

August 17, 2016—Endologix, Inc. announced that the first two patients have been treated with the investigational Ovation Alto abdominal stent graft system, which is designed for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs). The patients were treated by Andrew Holden, MD, and Andrew Hill, MD, of Auckland City Hospital in Auckland, New Zealand.

The company advised that Ovation Alto is an investigational device and currently not approved in any market. It is expected to be introduced in Europe in 2017 and the United States in 2018.

According to Endologix, Ovation Alto will allow for treatment of patients with very short or otherwise challenging aortic neck anatomy, which is achieved by the conformable O-rings with CustomSeal polymer that have been repositioned near the top of the endograft, providing seal just below the renal arteries. 

In the company’s press release, Dr. Holden commented, “The repositioned sealing ring in the Ovation Alto system expands the EVAR treatment of AAA patients to include short and challenging aortic necks, which represents a significant segment of the underserved complex AAA market. We are pleased to be the first center in the world to implant Ovation Alto and look forward to treating more patients and sharing our experience with the clinical community.”

Dr. Hill added, “The Ovation Alto system has the potential to increase the number of AAA patients treated with EVAR due to its unique sealing technology and ultra-low profile design. The new system is designed to provide the broadest indications of all infrarenal EVAR devices, which represents an important advancement for physicians and their AAA patients.”

Ovation Alto is the newest device in Endologix’s Ovation platform of abdominal stent graft systems. The Ovation platform is supported by clinical results from a 501-patient European Postmarket Registry and from the Ovation global pivotal trial, which was conducted in the United States, European Union, and South America. One-year data from the global pivotal trial were published by Manish Mehta, MD, et al in the Journal of Vascular Surgery (2014;59:65–73).

European CE Mark approval for Ovation was announced in September 2010. US Food and Drug Administration approval for Ovation was announced in October 2012.