Noticias

Noticias

  • Título: Endologix Announces Publication of Data From PEVAR Randomized Trial
  • Fecha: 18-02-2014

  • 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.



  • Fuente: endovascular.es