Endologix, Inc. (NSDQ:ELGX), developer of minimally invasive treatments for aortic disorders, announced today the online publication of a long-term outcome analysis of abdominal aortic aneurysm (AAA) patients from the pivotal, multicenter, prospective clinical trials for the Company’s Powerlink System. The outcome analysis concluded that in the presence of a normal initial post-operative computed tomography angiography (CTA) scan, Powerlink patients may replace lifelong CTA surveillance with duplex ultrasound imaging, which is a less expensive long-term surveillance modality with fewer potential health risks for patients and hospital staff.
Senior author of the study, Jeffrey P. Carpenter, MD, Professor and Chief, Department of Surgery, UMDNJ-Robert Wood Johnson Medical School at Camden, NJ, Cooper Health System, commented, “Although CTA is the current standard imaging modality for patients receiving an endovascular stent graft, the medical community is becoming increasingly concerned about its repeated use in patient follow-up due to the associated cancer and renal toxicity risks. Nonetheless, any practice change from this paradigm must be supported by evidence-based outcomes. We were pleased to find in our analysis of controlled trial data that for patients receiving the Powerlink stent graft, the first CTA scan, typically within 30 days postoperatively, is of great value in defining a more benign follow-up imaging regimen such as ultrasound. We have implemented this patient-centered decision-making algorithm for our Powerlink patients to effectively reduce their imaging-related exposure risks.”
The publication, entitled “The value of the initial post-EVAR computed tomography angiography scan in predicting future secondary procedures using the Powerlink stent graft,” is currently available online of the Journal of Vascular Surgery (JVS), and will be published in an upcoming issue of JVS. The study examined the long-term outcomes of 345 patients treated from July 2000 to November 2007 in the pivotal, multicenter, prospective clinical trials of the Powerlink System. An independent core laboratory analyzed 1,519 post-EVAR CTA scans in order to determine the value of the first post-operative CTA scan in predicting the long-term need for a secondary procedure.
John McDermott, President and Chief Executive Officer said, “This independent analysis of multicenter, prospective, core lab reviewed data further establishes the long-term safety and durability of the Powerlink System in the treatment of AAA, and represents a significant finding for our patients and the physicians who treat them. We believe these clinically-validated outcomes supporting the reduced use of CTA scans in appropriate patients will benefit the continued health of patients who receive the Powerlink stent graft. We also believe these outcomes have the potential to substantially reduce the healthcare costs associated with the imaging method and the associated complications.”
About Endologix Inc. (www.endologix.com)
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company’s flagship product is the Powerlink System, which is an endovascular stent graft for the treatment of abdominal aortic aneurysms (AAA). 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.