IRVINE, Calif., April 14 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.
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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."
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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."
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. Additional information can be found on Endologix's Web site at www.endologix.com
Forward-Looking Statements
Except for historical information contained herein, this news release contains forward-looking statements, specifically with respect to the possible timing and outcomes of clinical trials. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and the Company's other filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.
COMPANY CONTACT: INVESTOR CONTACTS: ---------------- ------------------ Endologix, Inc. The Ruth Group John McDermott, CEO Nick Laudico (646) 536-7030 (949) 595-7200 Zack Kubow (646) 536-7020 www.endologix.com
SOURCE Endologix, Inc.
