Endologix Inc. Announces Journal Of Vascular Surgery Publication Of Data From PEVAR Randomized Trial
IRVINE, Calif., February 18, 2014 --- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the Journal of Vascular Surgery’s (JVS) e-publication of the data from the first prospective, multicenter, randomized clinical trial of a totally percutaneous approach (PEVAR) to endovascular abdominal aortic aneurysm repair (EVAR).
The paper entitled, “A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial),” has reported the randomized trial results comparing PEVAR using the Endologix sheath-based system delivered using a percutaneous approach (the “pre-close” technique) with the Perclose ProGlide® Suture-Mediated Closure System from Abbott Vascular, with surgical access EVAR (SEVAR). The paper author and study principal investigator, Peter R. Nelson, M.D., M.S. (Assistant Professor of Vascular Surgery at University of Florida, Gainesville, FL), has received the Southern Association for Vascular Surgery (SAVS) Presidential Award in recognition for this outstanding contribution to the science of vascular surgery.
The trial met the primary endpoint of treatment success, demonstrating non-inferiority of PEVAR to SEVAR (p<0.004). Procedural technical success of PEVAR in the multicenter setting was 94 percent. The mean procedure time and the time to hemostasis were reduced in the PEVAR arm by 34 minutes (p=0.006) and 13 minutes (p=0.002), respectively. Additional clinical utility measures with trends favoring PEVAR included reduced anesthesia time, reduced blood loss and need for transfusion, shorter hospital length of stay, and fewer analgesics prescribed for groin pain.
On the basis of the PEVAR trial, the US Food and Drug Administration granted expanded labeling for the AFX® Endovascular AAA System, with specific indication for PEVAR (including a bilateral percutaneous approach). Currently, Endologix is the only endovascular systems developer to offer on-label, physician-proctored PEVAR training and support programs for physicians who are currently performing EVAR (endovascular aneurysm repair) and have prior experience and training in relevant standard percutaneous techniques.
Learn more at PEVARphysicians.com.
About The Journal of Vascular Surgery (JVS)
The Journal of Vascular Surgery (JVS) is the official journal of the Society for Vascular Surgery (SVS). Since the first issue was released in 1984, JVS has offered vascular, cardiothoracic, and general surgeons with original, peer-reviewed articles related to clinical and experimental studies, noninvasive diagnostic techniques, processes and vascular substitutes, microvascular surgical techniques, angiography, and endovascular management. In recent years, the Journal has also published a number of supplemental issues focused on patient diversity, diabetic foot ulcers, and other issues pertinent to the practicing vascular surgeon. Each month, JVS is mailed to nearly 6,000 subscribers. It ranks in the top 10 percent of the more than 8,000 scientific journals listed in the 2010 Science Citation Index© Thomson Reuters. JVS also ranks 10 out of 187 journals in surgery and 15 out of 66 journals in the peripheral vascular disease. The Journal's 2010 Impact Factor, a calculation of average citations per article, is 3.851.
About SAVS
The Southern Association for Vascular Surgery is a vascular surgical organization established to promote the art and science of peripheral vascular surgery, to further education, and to perpetuate friendships of its selected members. It is comprised of over 500 active, senior, candidate, honorary and corresponding members primarily from the 13 southern states of Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, South Carolina, Tennessee, Texas, Virginia, West Virginia, and Washington DC.
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. Endologix focus is endovascular stent grafts 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. Additional information can be found on Endologix's website at www.endologix.com.
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