Endologix, a developer and marketer of innovative treatments for aortic disorders, has enrolled the first patient in the company's US clinical trial to evaluate the Ventana fenestrated stent graft system for the endovascular repair of juxtarenal and pararenal abdominal aortic aneurysms (AAAs).
The Ventana device is an aortic extension designed to be used with the AFX endovascular AAA system and Xpand renal stent grafts.
The US Food and Drug Administration (FDA) has granted approval to conduct a multicentre prospective single arm Ventana clinical trial at up to 25 US clinical sites, involving 122 patients under an investigational device exemption (IDE). The trial is intended to evaluate safety at 30 days and effectiveness at one year, with continuing follow-up to five years.
Cleveland Clinic Foundation Department of Vascular Surgery professor Matthew Eagleton said the Ventana stent graft features movable fenestrations for in vivo adjustment to match the specific location of a patient's renal arteries along the aorta, required to address the anatomical challenges of the aneurysms.
''The Ventana system performed well and post-procedure imaging showed that the stent graft completely sealed the aneurysm and maintained blood flow to the kidneys," Eagleton added.
Cleveland Clinic Foundation Department of Vascular Surgery chairman Daniel Clair said the Ventana system is the first integrated, off-the-shelf endovascular stent graft device system in a multicentre, prospective clinical trial for patients with juxtarenal and pararenal AAAs.
The study will support a future premarket approval (PMA) application to the FDA, providing safety and efficacy data of the Ventana system.
Endologix president and CEO John McDermott said the international clinical experience with Ventana showed it has the potential to address approximately 20% of AAA patients with juxtarenal or pararenal aneurysms. In September 2011, the Ventana stent graft has received FDA clearance for treating endovascular repair of juxtarenal and pararenal aortic aneurysms.
Image: Endologix has recruited first patient to study Ventana fenestrated stent graft system.