Endologix has announced enrolment of 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.
The procedure was performed by Matthew Eagleton, Department of Vascular Surgery, Cleveland Clinic Foundation, USA, and Daniel G Clair, national principal investigator, chairman, Department of Vascular Surgery, Cleveland Clinic Foundation, proctored the procedure.
The multicentre, prospective, single arm Ventana clinical trial was approved by the US Food and Drug Administration (FDA) under an Investigational Device Exemption (IDE) for conduct at up to 25 US clinical sites and involving 122 patients. The trial is intended to support a future premarket approval (PMA) application to the FDA to provide reasonable assurances of safety and effectiveness for the Ventana system for the endovascular repair of juxtarenal and pararenal aneurysms in selected patients.
“We are excited to be the first investigational site to enrol a patient in the Ventana trial using this innovative new stent graft technology. This trial will offer participation to patients with abdominal aortic aneurysms that extend near or involve the renal arteries—patients who are not treatable with any of the approved endovascular aneurysm repair devices. The Ventana stent graft is designed with movable fenestrations for in vivo adjustment to match the specific location of a patient’s renal arteries along the aorta, which is essential to addressing the anatomical challenges of these 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 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 abdominal aortic aneurysms. The experience with our first Ventana patient in the USA highlighted the fenestration movement, ease of use, and aneurysm sealing attributes of the device and, more importantly, provided a minimally invasive treatment option for a patient that previously could not be offered an approved endovascular option. We look forward to begin treating patients at other clinical trial sites in the near future,” Clair added
The trial primary endpoints will evaluate safety (major adverse events) at 30 days and effectiveness (treatment success) at one year, with continuing follow-up to five years.
John McDermott, president and CEO, Endologix, said: “Enrolling the first patient in our Ventana US clinical trial is another key milestone in the path towards bringing this important technology to patients in the USA. The international clinical experience with Ventana demonstrates that it has the potential to be the only off-the-shelf EVAR system to address approximately 20% of abdominal aortic aneurysm patients who have juxtarenal or pararenal aneurysms.”