First patient enrolled in Endologix percutaneous EVAR pivotal clinical trial

Endologix, Inc.Apr 15 2010

Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced today 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 patient was treated at Oklahoma Heart Hospital by Jim G. Melton, DO.  

Dr. Melton said, "It is an honor to be the first site to enroll a patient in the Endologix percutaneous EVAR pivotal clinical trial.  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."

Standard EVAR procedures require an open surgical cut-down of one or both femoral arteries for delivery system access and device deployment.  Percutaneous EVAR ("PEVAR") procedures do not require an open surgical cut-down of either femoral artery, as access to the femoral artery is achieved via a percutaneous ("across the skin") approach.  There are currently no medical devices approved by the United States Food and Drug Administration ("FDA"), or in pivotal clinical trials, for a PEVAR indication.

Up to 20 U.S. clinical sites will enroll 150 patients in the randomized trial.  All patients in the clinical trial will be treated with the Endologix IntuiTrak® endovascular delivery system, which delivers the Company's Powerlink® family of stent grafts.  The clinical trial is also utilizing a "pre-close" technique facilitated by the Abbott Vascular, Inc. Prostar® XL Percutaneous Vascular Surgical System or Perclose ProGlide® Suture-Mediated Closure System.  One hundred patients will undergo percutaneous endovascular abdominal aortic aneurysm repair ("PEVAR") with closure facilitated by either the Prostar XL or Perclose ProGlide device, and 50 patients will undergo standard EVAR.  

John McDermott, Endologix President and Chief Executive Officer, said, "The beginning of enrollment in the first and only FDA-approved clinical trial for percutaneous EVAR is a major milestone for Endologix.  We expect that this study will provide the clinical evidence to support a percutaneous indication for our products, allowing patients to benefit from the truly minimally invasive, percutaneous approach that we are examining.  The clinical trial will also provide incremental exposure for our IntuiTrak® and Powerlink® products in the medical community as more physicians become aware of the study."