Endologix has announced today that the first patients were treated in the ELEVATE (Expanding patient applicability with polymer sealing Ovation Alto stent graft) investigational device exemption (IDE) clinical study, the company’s pivotal clinical trial to evaluate the safety and effectiveness of the Ovation Alto abdominal stent graft system for the repair of infrarenal abdominal aortic aneurysms.
The ELEVATE IDE clinical trial is approved to enrol 75 patients at up to 12 centres in the USA. The first procedure was performed by Steve Henao, chief, Division of Vascular Surgery at New Mexico Heart Institute (Albuquerque, USA).
The study principal investigator, Sean Lyden, chairman of the Department of Vascular Surgery at Cleveland Clinic (Cleveland, USA) commented, “We are excited to start treating patients in the ELEVATE IDE trial. The polymer technology in the device allows for active sealing in the aortic neck. The polymer sealing ring has proven durability in maintaining aneurysm exclusion to five years as reported in the Global Ovation pivotal trial. The repositioning of the sealing ring to 7mm below the top of the fabric will allow treatment of more challenging and complex anatomies in this trial.”
Ovation Alto is the newest device in the Ovation platform of abdominal stent graft systems, which has proven clinical results reported from the Ovation global pivotal trial and European post-market registry. Endologix says that Ovation Alto expands EVAR to treat more patients on instructions for use (IFU). 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 endovascular aneurysm repair (EVAR) device, and it has been used successfully in the treatment of over 12,000 patients worldwide. Ovation Alto is an investigational device and currently not approved in any market.
John McDermott, chief executive officer of Endologix, said, “The first patients enrolled in the ELEVATE IDE represent an important milestone for the company, as we continue to advance our portfolio of innovative technologies for the treatment of abdominal aortic aneurysm. Ovation Alto is the only infrarenal EVAR device that addresses a broad range of patients on IFU, representing a meaningful market opportunity. When approved, we expect that it will have the broadest indication for use of all infrarenal EVAR devices. We would like to thank physicians worldwide for their design input and participation in the previous and new clinical studies. Based on the anticipated enrolment timeline, we continue to expect Ovation Alto could be available in the USA in 2019.”