Interventional device developer Endologix reported that it has completed its enrollment of a multicenter, nonrandomized, controlled Investigational Device Exemption clinical trial. The Irvine, Calif.-based firm said that the trial is intended to support U.S. Food and Drug Administration (FDA) approval of its large 34-mm diameter Powerlink infrarenal cuff in conjunction with its Powerlink bifurcated stent graft system.
The Powerlink System is a bifurcated endoluminal stent graft approved by the FDA for the minimally invasive treatment of abdominal aortic aneurysm. In this trial, a 28-mm Powerlink System bifurcated stent graft was utilized with a 34-mm proximal cuff to exclude blood flow from the aneurysm in patients with aortic necks up to 32 mm in diameter.
Patients will continue to be followed to complete the one-year primary endpoint analysis, during which time an additional 120 patients may be treated and followed at up to 20 clinical sites under an FDA-approved continued access provision of this protocol, Endologix said.