US-based Endologix has started patient enrolment in expanding applicability with polymer sealing ovation alto stent graft (ELEVATE) investigational device exemption (IDE) as part of a clinical study of the Ovation Alto to repair infrarenal abdominal aortic aneurysms (AAAs).
A part of the firm's Ovation platform, Ovation Alto is a abdominal stent graft system designed to expand the endovascular aneurysm repair (EVAR) for treating more patients on IFU.
The ELEVATE study will assess the safety and effectiveness of the device in 75 patients at up to 12 centres in the US.
Endologix chief executive officer John McDermott 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 AAA.
"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."
The conformable O-rings with CustomSeal polymer have been repositioned at the top of the endograft to enable seal below the renal arteries.
The polymer technology further facilitates active sealing in the aortic neck and the repositioning of the ring to 7mm below the top of the fabric is expected to allow treatment of challenging and complex anatomies.
It is estimated that the Ovation Alto abdominal stent graft system will be available in the US in 2019.
