Endologix has concluded patient enrolment in the company's clinical trial of a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair (EVAR).
Endologix is the first to receive US Food and Drug Administration (FDA) approval of an Investigational Device Exemption (IDE) to evaluate percutaneous EVAR (PEVAR) for treating abdominal aortic aneurysms (AAA).
The prospective multicentre randomised study enrolled 191 patients, intended to support the safety and effectiveness of Endologix's IntuiTrak endovascular delivery system and Powerlink family of stent grafts in the percutaneous treatment of AAA.
The study features a "pre-close" technique facilitated by Abbott's Prostar XL percutaneous vascular surgical system or Perclose ProGlide suture-mediated closure system.
In the randomised arm of the study, 100 patients underwent PEVAR with closure facilitated by either the Prostar XL or Perclose ProGlide device, and 50 patients underwent standard EVAR.
Endologix president and chief executive officer John McDermott said the findings from the roll-in phase of the trial are encouraging, with 95% technical success and an average 1.7-day hospital stay.
''The completion of enrolment in our PEVAR clinical trial is an important milestone for our new product pipeline. It clearly positions Endologix to be the first and only company to receive a totally percutaneous indication for EVAR and to be able to train physicians on the PEVAR procedure,'' McDermott added.
Following FDA IDE approval, the company has combined the IntuiTrak delivery system and Powerlink stent grafts into a single next-generation platform called the AFX endovascular AAA system, which includes a lower profile introducer sheath.
The company plans to submit a premarket approval application (PMA) with the primary endpoint results to request FDA approval for the extended PEVAR indication during the second quarter of this year.
Endologix develops and manufactures minimally invasive endovascular stent grafts for the treatment of aortic disorders.