First Report Of Clinical Outcomes Presented From The Endologix Powerlink Suprarenal Extension Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 22 Mar 2009 - 2:00 PDT

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Endologix, Inc. (NASDAQ: ELGX), the developer and manufacturer of the Powerlink® System for the minimally invasive treatment of abdominal aortic aneurysms (AAA), announced the first presentation of initial outcomes with up to two-year patient follow-up from its Powerlink Suprarenal Proximal Extension trial at the Society for Clinical Vascular Surgery's 37th Annual Symposium in Ft. Lauderdale, Fla. The presentation entitled, "EVAR Using an Anatomical Fixation Technique with Suprarenal Orientation: Results of a Prospective, Multicenter Trial," was delivered by principal investigator and lead enroller Stuart A. Harlin, M.D., FACS of Sacred Heart Medical Center in Pensacola, Fla.

The prospective, multicenter, single-arm trial was performed in eight U.S. clinical sites. All 44 enrolled patients received the Powerlink infrarenal bifurcated stent graft via anatomical fixation at the native bifurcation, with concomitant placement of the suprarenal proximal extension to achieve proximal seal. Of the patients enrolled, 93% had one or more hostile aortic neck anatomical characteristics, including a high degree of angulation, presence of severe thrombus, or reverse tapering. Results include mid-term follow-up for up to two years.

Key outcomes and follow-up results from the trial include:

- 100% technical success;
- No aneurysm rupture;
- No conversion to open surgical repair;
- No migration;
- Excellent device performance and integrity with no stent fracture, no ePTFE graft failure, and no Type III or Type IV endoleak;
- 93% survival at one year, with no aneurysm-related mortality;
- >90% of patients at one year with a stable or significantly reduced aneurysm sac diameter.

Dr. Harlin, a principal investigator in this study, stated, "One challenge with endovascular aortic repair in a patient having complex aortic neck anatomy is obtaining an effective proximal seal. In this trial, the anatomically-fixed Powerlink bifurcated stent graft coupled with the suprarenal proximal extension proved highly effective in this patient group. The superb outcomes in this trial demonstrate that this treatment algorithm and device offers physicians and their patients with AAA an excellent endovascular option."

Endologix President and CEO John McDermott stated, "Beginning with the successful delivery and deployment of the study devices in 100% of the patients, and continuing to the exceptional clinical results up to two years, this trial demonstrates that the device performed very well in this difficult-to-treat patient population. Consistent with all prior Powerlink trials to date, the vast majority of aortic aneurysm sac diameters were stable or significantly reduced in size, which is important in avoiding late complications and reinterventions. We are delighted with these results, which build on the well-established Powerlink safety and effectiveness profile. In addition, we are pleased to be the only provider of a device that gives physicians the choice of infrarenal or suprarenal configurations to treat their AAA patients."

About Endologix

Endologix, Inc. develops and manufactures innovative therapies for aortic disorders. 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. The overall patient mortality rate for ruptured AAA is approximately 75%, making it a leading cause of death in the U.S. Additional information can be found on Endologix's Web site at http://www.endologix.com.

Except for historical information contained herein, this news release contains forward-looking statements specifically including expected physician acceptance of the Endologix Powerlink Suprarenal Proximal Extension System, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. The Company undertakes no obligation to update its forward looking statements. 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 these risks and other factors that may cause actual results to differ materially from those expressed or implied.

Source
Endologix

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