Endologix Powerlink Suprarenal Extension Trial Releases Preliminary Outcomes
March 20, 2009 - Endologix Inc. yesterday announced the first presentation of initial outcomes with up to two-year patient follow-up from its Powerlink Suprarenal Proximal Extension trial; the Powerlink System is for the minimally invasive treatment of abdominal aortic aneurysms (AAA).
The outcomes were presented at the Society for Clinical Vascular Surgery’s 37th Annual Symposium in Ft. Lauderdale, FL and delivered by principal investigator and lead enroller Stuart A. Harlin, M.D., FACS of Sacred Heart Medical Center in Pensacola, FL.
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 percent 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 percent survival at one year, with no aneurysm-related mortality;
- >90 percent of patients at one year with a stable or significantly reduced aneurysm sac diameter
“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,” said principal investigator Dr. Harlin.
For more information: www.endologix.com.