On 9 February, Endologix announced the completion of patient enrolment in the prospective, multicentre, randomised clinical trial of a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair (EVAR).
According to a company release, Endologix is the first company to receive US Food and Drug Administration (FDA) approval of an Investigational Device Exemption (IDE) to evaluate percutaneous EVAR (PEVAR) for the treatment of abdominal aortic aneurysms.
The PEVAR clinical trial is designed to support the safety and effectiveness of Endologix’s IntuiTrak endovascular delivery system and Powerlink family of stent grafts in the percutaneous treatment of abdominal aortic aneurysm. The clinical trial incorporates a “pre-close” technique facilitated by Abbott’s Prostar XL percutaneous vascular surgical system or Perclose ProGlide suture-mediated closure system.
This multicentre, prospective, randomised clinical trial enrolled 191 patients (41 roll-in patients and 150 randomised patients) at 20 US clinical sites. In the randomised arm of the study, 100 patients underwent percutaneous EVAR with closure facilitated by either the Prostar XL or Perclose ProGlide device, and 50 patients underwent standard EVAR, which required an open surgical cut-down of one or both femoral arteries for delivery system access and device deployment.
John McDermott, president and CEO, Endologix, said: “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. The results from the roll-in phase of the trial were very promising with 95% technical success and an average 1.7-day length of hospital stay, supporting our belief that physicians and patients will be attracted to this less invasive procedure.”
The company expects to submit a supplement to its premarket approval application (PMA) with the primary endpoint results to request FDA approval for this broadened PEVAR indication during the second quarter of 2012.