Noticias

Noticias

  • Título: Endologix to Initiate First Ever Comparative Randomized EVAR Study
  • Fecha: 29-09-2014

  • LEOPARD Study to Enroll 600 Patients to Provide a 'Real-World'Head-to-Head Comparison of the AFX® System Versus Other Commercially AvailableEVAR Devices

    IRVINE, Calif., Sept.29, 2014 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX),developer and marketer of innovative treatments for aortic disorders, announcedtoday that it will conduct the first ever prospective randomized clinical studyto compare outcomes in endovascular repair of abdominal aortic aneurysms (EVAR).The LEOPARD Study (Looking at EVAR Outcomes by Primary Analysisof Randomized Data) has been designed to provide anaccurate and unbiased assessment of commercially available EVAR devices with aplanned enrollment of 600 patients.

    Christopher J. Kwolek,MD, Director, Vascular and Endovascular Training program at the MassachusettsGeneral Hospital and Chief of Vascular Surgery at Newton WellesleyHospital in Boston and the National Principal Investigator forthe LEOPARD Study, said, 'LEOPARD is a landmark study that is intended toproduce the highest level of clinical evidence. I applaud Endologix forsupporting a head-to-head real-world comparison of commercially availabledevices here in the United States. The primary analysis will compare Endologix's AFX® EndovascularAAA System against an equally matched control population of othercommercially available EVAR devices. Results from LEOPARD will help shape EVARtreatment decisions and technology development in order to provide the bestpossible outcomes for our patients.'

    LEOPARD will includeup to 60 active EVAR centers throughout the United States. The primaryendpoint of the study is treatment success at one year based upon: proceduralsuccess; and rates of freedom from aneurysm rupture; conversion to opensurgical repair; endoleaks; clinically significant device migration; aneurysmenlargement and secondary endovascular procedures. Results from the study willbe independently adjudicated by a third-party. The follow-up period will befive years.

    The steering committeefor the LEOPARD study includes:

    · Christopher Kwolek, MD, Director, Vascular and Endovascular SurgeryTraining Program, Massachusetts General Hospital, Chief of VascularSurgery at Newton Wellesley Hospital, in Boston (NationalPrincipal Investigator)

    · Benjamin Starnes, MD, Professor of Surgery and Chief of the VascularSurgery Division, University of Washington (Steering CommitteeChairman)

    · Daniel Clair, MD, Chairman of Vascular Surgery, Cleveland Clinic

    · Mark Fillinger, MD, Director, Vascular Surgery Training Programs, Professorof Surgery, Geisel School of Medicine, Dartmouth

    · Tom Maldonado, Associate Professor of Surgery, New York UniversityLangone Medical Center, Chief of Vascular Surgery, Manhattan VA Hospital

    · Timothy Sullivan, MD, Chairman, Vascular/Endovascular Surgery, MinneapolisHeart Institute at Abbott Northwestern Hospital

    · Frank Veith, MD, Professor of Surgery, Cleveland Clinic and NewYork University

    About Endologix,Inc.

    Endologix, Inc. developsand manufactures minimally invasive treatments for aortic disorders. Endologix focusis 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 thebody, resulting in a balloon-like enlargement. Once AAA develops, it continuesto enlarge and, if left untreated, becomes increasingly susceptible to rupture.The overall patient mortality rate for ruptured AAA is approximately 80%,making it a leading cause of death in the U.S. Additional information can befound on Endologix's website atwww.endologix.com.

    Cautions RegardingForward-Looking Statements

    Except for historicalinformation contained herein, this news release contains forward-lookingstatements within the meaning of the Private Securities Litigation Reform Actof 1995, including with respect to the anticipated number of sites and patientenrollment in the LEOPARD study, and the ability of the data arising from theLEOPARD study to shape EVAR treatment decisions and technology development, theaccuracy of which are necessarily subject to risks and uncertainties, all ofwhich are difficult or impossible to predict accurately and many of which arebeyond the control of Endologix. Many factors may cause actual results todiffer materially from anticipated results, including the ability of theCompany to recruit hospitals and surgeons to participate in the study and theirability to enroll patients, and other technical and clinical factors. Unduereliance should not be placed on forward-looking statements, which speak onlyas of the date they are made. Endologix undertakes no obligation toupdate any forward looking statements to reflect new information, events orcircumstances after the date they are made, or to reflect the occurrence ofunanticipated events. Please refer to Endologix's Annual Report onForm 10-K for the year ended December 31, 2013, and Endologix's otherfilings with the Securities and Exchange Commission, for more detailedinformation regarding these risks and other factors that may cause actualresults to differ materially from those expressed or implied.

    CONTACT: COMPANY CONTACT:

    Endologix, Inc.

    John McDermott, CEO

    Shelley Thunen, CFO

    (949) 595-7200

    www.endologix.com

    INVESTOR CONTACTS:

    The Ruth Group

    Nick Laudico (646) 536-7030

    Zack Kubow (646) 536-7020

    Source: Endologix

    News Provided byAcquire Media



  • Fuente: endovascular.es