ENDOLOGIX SUBMITS Powerlink PMA TO THE FDA
Irvine, Calif. – January 8, 2004 – Endologix, Inc. (Nasdaq: ELGX) today announced it has filed its completed pre-market approval (PMA) submission with the U.S. Food and Drug Administration (FDA) for the Powerlink® System, an endoluminal stent graft (ELG) for the minimally invasive treatment for abdominal aortic aneurysms (AAA). The completed PMA application includes the clinical results from Endologix's pivotal trial as the final step in the modular PMA submission process. Endologix anticipates receiving FDA approval for marketing the Powerlink System in the U.S. in the second half of 2004.
"This marks the achievement of a significant milestone for Endologix, and represents the culmination of our pre-clinical and clinical work to commercialize what we believe to be a superior minimally invasive treatment for life-threatening AAA. It is a testament to the tireless efforts of the Endologix employees, our investigators and their research staff," commented Paul McCormick, president and chief executive officer. "Over the next 45 days the FDA must determine that all the necessary components of the submission are included and that the application is 'fileable.' Once deemed fileable, the review of the clinical data will begin and the Company will work with the Agency to answer any queries prior to the FDA's determination of the need for a panel meeting. Two of the four previously submitted modules have already been reviewed and accepted. Queries regarding the remaining two modules will be addressed during the final PMA review period. We believe the data submitted is not materially different than that which has been previously reported, and we are confident that we will achieve our goal of gaining U.S. marketing approval for the Powerlink System in 2004."
Powerlink System Pivotal Clinical Trial
Endologix's pivotal clinical study cohort consists of 259 patients, 193 test and 66 control patients. The Company previously reported preliminary pivotal trial results from 154 patients who were monitored for a minimum of one year. The Powerlink was safely deployed in 151 patients (98%) with no device related aneurysm ruptures, wire fractures, or material failures reported during this follow-up period. These findings were presented by Jeffrey Carpenter, M.D., professor of surgery at the University of Pennsylvania, at the September 2003 Transcatheter Cardiovascular Therapeutics Conference and the December VEITH symposium.
Abdominal Aortic Aneurysms
An abdominal aortic aneurysm is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once an AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAAs is approximately 75%, making it the 13th leading cause of death in the U.S. Most patients with an AAA do not exhibit any symptoms and the first sign oftentimes is a rupture of the aneurysm. When an AAA ruptures, patients will experience pain in the abdomen and back, fainting and loss of consciousness frequently leading to shock and death. Once diagnosed, AAA patients will be managed by a combination of medical therapy and non-invasive monitoring, or by undergoing a major surgical procedure to repair the aneurysm.
Modular Filing Process
In May 2003, Endologix announced the FDA acceptance of a modular PMA shell submission for the Powerlink System. The modular filing process allows for an ongoing dialogue with FDA officials and assists a Company to respond to FDA requirements earlier in the process. Endologix has filed of all four required modules for consideration with the FDA with the first two modules regarding manufacturing and quality systems and preclinical animal studies filed in May, the module including preclinical material biocompatibility studies in July and the remaining examining the engineering preclinical studies in September.
Except for historical information contained herein, this news release contains forward-looking statements, the accuracy of which are necessarily subject to risks and uncertainties, including risks related to clinical trials and the regulatory approval process, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix, all as more fully described in the risk factors and other matters set forth in the Company's Annual Report on Form 10-K for the year ended Dec. 31, 2002 and the Company's other filings with the U.S. Securities Exchange Commission.