Follow-up data support safety, effectiveness of Endologix's Powerlink System

By E. Janene Geiss

Philadelphia, Feb. 16 - Endologix, Inc. announced Thursday that four-year patient follow-up data from the company's Powerlink System pivotal clinical trial supports the safety and effectiveness of the Powerlink as an endoluminal stent graft in protecting patients from rupture of the abdominal aortic aneurysm.

The results of the study of 192 patients found that only 26 patients needed a secondary procedure and most were treated for Type II endoleak, indicating the need for the secondary procedure was not device-related, according to a company news release.

All cohorts treated with the system experienced aneurysm sac diameter and volume reductions, shrinking of the aneurysm sac around the device and minimal change in the length of the aorta from the most distal renal artery to aortic bifurcation, officials said.

The Powerlink's column strength and unique long main body may directly influence the remodeling of the aneurismal aorta, officials said.

Of the 192 patients followed for 48 months, 97.9% of patients were free from abdominal aortic aneurysm-related mortality with no reported aneurysm ruptures, no ePTFE graft material failures and no cobalt chromium stent graft failure or fatigue.

There was only one late conversion that occurred at one year, officials said.

The data was presented by Rodney A. White, professor of surgery at UCLA School of Medicine and chief of vascular surgery at Harbor-UCLA Medical Center, at the International Congress XIX on Endovascular Interventions.

Two additional presentations featuring treatment with the Powerlink System also were showcased at the meeting, officials said.

"The International Congress provides an excellent forum to highlight the positive attributes of our Powerlink System, supporting our objective of driving physician acceptance for our [endoluminal stent graft]," Paul McCormick, Endologix president and chief executive officer, said in the release.

Endologix, based in Irvine, Calif., develops and manufactures minimally invasive treatments for vascular diseases.

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