Endologix Announces First Patients Treated with Ovation Alto™ Abdominal Stent Graft System

Ovation Alto™ Designed to Expand EVAR to Include the Treatment of Patients with Complex AAAs

IRVINE, Calif., Endologix, Inc., developer and marketer of innovative treatments for aortic disorders, announced today the first two patients with abdominal aortic aneurysms (“AAA”) have been treated with the Ovation Alto™ Abdominal Stent Graft System. The patients were treated by Andrew Holden, MD, and Andrew Hill, MD, of Auckland City Hospital, Auckland, New Zealand.

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 said, “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 the Ovation^® platform of abdominal stent graft systems, which has excellent clinical results reported from the Ovation global pivotal trial and a 501-patient European Post-Market Registry. Ovation Alto expands EVAR to include the treatment of patients with complex AAAs, specifically patients with very short or otherwise challenging aortic neck anatomy. This 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. The Ovation platform is the lowest profile FDA-approved EVAR device and has been used successfully in the treatment of approximately 10,000 patients worldwide. Ovation Alto is an investigational device and currently not approved in any market.  It is expected to be introduced into Europe in 2017 and the U.S. in 2018.

Bob Mitchell, President of Endologix, said, “The first patients treated with the Ovation Alto system is a significant milestone for our new product strategy. It further enhances our leadership position in the development of unique sealing technologies for the treatment of AAA and broadens our product portfolio to address a wide range of anatomies, including the underserved complex AAA market. We would like to thank Dr. Holden and Dr. Hill for their collaboration in the first patients treated with the Ovation Alto system.” 

Source: Endologix, Inc.