FOUR-YEAR ITALIAN COMPARATIVE STUDY SUPPORTS ENDOLOGIX Powerlink SINGLE-PIECE DESIGN
Study Data to be Presented at the International Congress Conference
Irvine, Calif. - February 11, 2004 - Endologix, Inc. (Nasdaq: ELGX) today announced that data from a four-year retrospective comparative Italian study supports the Endologix Powerlink® System's one-piece design, compared with modular design endoprostheses for the treatment of abdominal aortic aneurysms (AAAs). Gioacchino Coppi, M.D., Director of the Vascular Division of the S. Agostino Hospital in Modena, Italy was the principal investigator. The study findings will be presented today by Stefano Gennai, M.D., assistant of Dr. Coppi at the International Congress XVII conference in Scottsdale, Arizona.
About the study, Dr. Gennai commented, "We were able to quickly deploy the Powerlink in patients selected to participate in the study based on their anatomical characteristics. Post surgery, we noted that aneurysm sacs decreased quicker in patients who received the Powerlink than in those with the modular endoprostheses we studied. Additionally, the Powerlink proved very stable, with no reported late cases of device migration."
Data from the study were compiled from 549 patients treated for AAAs between October 1994 and June 2003. This report was on 92 patients treated with the Powerlink during the October 1999 to June 2003 period. It was successfully deployed in 89 cases (96.7%) with no device related deaths. The mean duration of the deployment procedures was 91 minutes, with a range of 35 to 180 minutes for all procedures. Patient follow-ups were conducted at three, six and 12 months, and then annually during the remainder of the study. The average reduction in diameter of the aneurysm sac was 44.0% at three months and 66.6% at 12 months.
The study results showed three early endoleaks (3.3%) at 30 days and four late endoleaks (4.3%). At 36 months, 91% of the patients were free from endoleaks. No procedure-related late mortality was encountered and the cumulative survival rate at 36 months was 95%.
"The favorable results from this four-year study further supports the Powerlink's single-piece, bifurcated design in overcoming the problems of first-generation endoluminal stent grafts," said Paul McCormick, Endologix president and chief executive officer. "AAA disease is a significant clinical problem with few good options. Although the current U.S. market for AAA stent grafts is estimated at $200 million, many physicians have been selective in their application due to mixed results based on first generation designs. We believe the dependability of the Powerlink clinical results and the durability of the device design will increase physician acceptance."
The Company previously announced that it has filed a full pre-market approval submission with the U.S. Food and Drug Administration and expects to receive U.S. marketing approval for the Powerlink in the second half of 2004.
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 noninvasive 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.