Endologix Enrolls First AAA Patient in Clinical Trial for Fully Percutaneous EVAR Treatment

April 14, 2010—Endologix, Inc. (Irvine, CA) announced that the first patient has been enrolled in the company's prospective, multicenter, randomized clinical trial for a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair (EVAR). The company noted that there are currently no medical devices either approved by the US Food and Drug Administration or in pivotal clinical trials for a fully percutaneous EVAR indication, which does not require an open surgical cutdown of either femoral artery.



According to Endologix, up to 20 clinical sites in the United States will enroll 150 patients in the randomized trial. All patients in the clinical trial will be treated using the Endologix IntuiTrak endovascular delivery system, which delivers the company's Powerlink family of stent grafts. The clinical trial is also utilizing a preclose technique facilitated by the Prostar XL percutaneous vascular surgical system or Perclose ProGlide suture-mediated closure system (Abbott Vascular, Santa Clara, CA). One hundred patients will undergo percutaneous EVAR with closure facilitated by either the Prostar XL or Perclose ProGlide device, and 50 patients will undergo standard EVAR.

Jim G. Melton, DO, who enrolled the trial's first patient at Oklahoma Heart Hospital, commented, “The low-profile design of the company's products makes them ideally suited for a percutaneous approach to EVAR and provides patients with a truly minimally invasive option for AAA repair. Patients may also benefit from the use of local anesthesia instead of general anesthesia, shorter procedure time, shorter time to ambulation, and faster times to discharge.”