Endologix, developer and marketer of treatments for aortic disorders, announced 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, M.D., and Andrew Hill, M.D., of Auckland City Hospital, Auckland, New Zealand.
“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,” Dr. Holden said.
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 O-rings with CustomSeal polymer that have been repositioned near the top of the endograft, providing seal just below the renal arteries.
“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,” Dr. Hill said. “The new system is designed to provide the broadest indications of all infrarenal EVAR devices.”
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.