FDAnews Device Daily Bulletin


Nov. 22, 2005

Data from a long-term trial of Endologix's Powerlink System supports the durability of the endoluminal stent graft in treating abdominal aortic aneurysms (AAA), according to Endologix.

Of the 192 patients monitored in the four-year follow-up trial, only 24 to date have required secondary procedures, said Rodney White, professor of surgery at UCLA School of Medicine and chief of vascular surgery at Harbor-UCLA Medical Center. The pivotal trial had a mean follow-up time of 30.20 months and a maximum follow-up time of 48.62 months, White said according to a statement released by Endologix.

Approved in October 2004, the Powerlink System is a minimally invasive device that treats AAA, which is a weakening of the aorta wall that results in a balloon-like enlargement, Endologix said. If left untreated, AAA becomes increasingly susceptible to rupture -- a condition that has a mortality rate of roughly 75 percent.

The majority of patients in the Powerlink trial who required a second procedure were treated for Type II endoleak -- or blood flow in the aneurysm sac -- indicating that the need for secondary procedure was not device specific, said White, who presented the data at the VEITH symposium in New York, a leading conference for vascular surgeons and specialists.

Of the 53 patients who were followed for 48 months, the study found: 97.9 percent were free from AAA mortality; there were no reported graft material failures; there were no reported stent fractures; and aneurysm remodeling continues, as noted by a continued reduction in both aortic sac diameter and volume.

"We were exceptionally pleased with the positive four-year data presented at the VEITH symposium, which is an important conference in reaching thought leaders in the endovascular community," said Paul McCormick, president and CEO of Endologix. "We believe this data that provides evidence of our device's durability over time will further support commercialization of the Powerlink System."

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