Endologix Receives IDE Approval For Fully Percutaneous Approach To EVAR

Main Category: Vascular
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 19 Nov 2009 - 2:00 PDT

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Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced that it has received Investigational Device Exemption (IDE) conditional approval from the United States Food and Drug Administration ("FDA") to begin a prospective, multicenter, randomized clinical trial for a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair (EVAR) utilizing the Company's IntuiTrak(TM) endovascular delivery system for the Powerlink® family of stent grafts.

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 FDA, or in pivotal clinical trials, for a percutaneous EVAR indication. The Company plans to initiate this first pivotal clinical trial for percutaneous EVAR in the first quarter of 2010. Based on the trial results, Endologix intends to submit a future PMA supplement for a broadened indication for the IntuiTrak endovascular delivery system to include PEVAR in suitable patients and will initiate widespread physician training programs on this technique.

John McDermott, Endologix President and Chief Executive Officer, said, "The approval for our percutaneous EVAR pivotal clinical trial further demonstrates Endologix's commitment to become the innovation leader in the repair of abdominal aortic aneurysms. The unique attributes of our products, including the ease-of-use and low-profile design of the IntuiTrak endovascular system, makes the percutaneous approach possible. In addition, our Powerlink System is the only endovascular stent graft that utilizes anatomical fixation, which has been shown in clinical trials to yield exceptional long-term patient outcomes."

The trial will utilize a "pre-close" technique facilitated by the Prostar® XL Percutaneous Vascular Surgical System or Perclose ProGlide® Suture-Mediated Closure System, both made by Abbott. Up to 20 U.S. clinical sites will enroll 150 patients in the randomized trial. One hundred patients will undergo PEVAR with closure facilitated by either the Prostar XL or Perclose ProGlide device, and 50 patients will undergo standard surgical cut-down EVAR. All patients will be treated with the IntuiTrak endovascular delivery system.

About Endologix, Inc.

Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company's flagship product is the Powerlink® System, which is an endovascular stent graft for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture.

Forward-Looking Statements

Except for historical information contained herein, this news release contains forward-looking statements, specifically with respect to the initiation and timing of clinical trials, and the possible outcomes there from. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2008, and the Company's other filings with the Securities and Exchange Commission, for more detailed information regarding regulatory and clinical risks and other factors that may cause actual results to differ materially from those expressed or implied.

Source: Endologix, Inc

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