Endologix PowerLink System PMA Submission Gains Fileable Status with FDA; Acceptance of Filing Marks Important Milestone in U.S. Market Approval Process.

Business Editors/Health/Medical Writers

IRVINE, Calif.--(BUSINESS WIRE)--Feb. 17, 2004

Endologix Inc. (Nasdaq:ELGX) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's filing of the pre-market approval (PMA) submission for the PowerLink(R) System, an endoluminal stent graft (ELG) for the minimally invasive treatment for abdominal aortic aneurysms (AAA). Acceptance of the filing means that the FDA has made a threshold determination that the PowerLink PMA submission is sufficiently complete to move forward in the FDA review and approval process.

The date that the FDA deems a PMA submission fileable marks the continuance of a 180-day period, which began Jan. 8, 2004, in which the agency conducts an in-depth scientific, regulatory and quality system review of that PMA submission. During the review period, Endologix will work with the FDA to answer any queries. Based on the timing of obtaining FDA fileability status, Endologix expects to meet with the FDA in April to discuss any major issues from the agency's review. At that time, the FDA will determine the need for an FDA panel meeting before moving forward with its decision regarding U.S. marketing approval.

"The FDA's finding of fileability marks another important advance and keeps us on track in our efforts to obtain U.S. marketing approval for the PowerLink during the second half of this year," said Paul McCormick, president and chief executive officer. "Furthermore, the FDA has already reviewed and accepted two of our four previously submitted PMA modules. Based on our regulatory progress to date, and the strength of our clinical results, we are convinced that we will reach our goal."

Endologix's pivotal clinical study cohort consists in part of the following fundamental data:

Enrollment of 259 patients: 193 PowerLink test patients and 66
surgical controls:

--  Deployment Success - 97.8%

--  Mean Length of Hospital Stay - 3.4 days

--  30 day Mortality (2) - 1.09% (not device related)

One year clinical follow up was submitted on 184 patients:

--  AAA Ruptures - 0

--  Secondary Procedures: (10) - 5.4% to treat endoleaks

                           (4) - 2.2% to treat device obstructions

CT scans were analyzed by an Independent Core Lab:

--  13.2% endoleak rate at one year, 5.6% endoleak at two years

--  Greater than 5 mm Device Migration (5) - 3.8%

--  Wire Fractures - 0

--  Material failures - 0

About Endologix

Endologix Inc. develops and manufactures minimally invasive treatments for vascular diseases. AAA, a life threatening condition, 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. The overall patient mortality rate for ruptured AAAs is approximately 75%, making it the 13th leading cause of death in the United States. 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.

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.