Noticias

Noticias

  • Título: Endologix Announces Enrollment of First Patient in EVAS FORWARD-IDE Clinical Trial
  • Fecha: 21-01-2014

  • IRVINE, Calif., Jan. 21, 2014 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that the first patient was treated in the EVAS FORWARD-IDE clinical trial, the Company's pivotal clinical trial to evaluate the safety and effectiveness of the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System") for the endovascular repair of infrarenal abdominal aortic aneurysms. The EVAS FORWARD-IDE clinical trial is approved to enroll 180 patients at up to 30 centers in the U.S., Canada andEurope, of which approximately 25 will be in the U.S. The first procedure was performed by Professor Dittmar Boeckler, MD, a vascular surgeon atHeidelberg University Hospital in Germany.

    Professor Boeckler commented, "The Nellix EVAS System is a breakthrough in endovascular aneurysm treatment. Sealing the entire aneurysm sac with the Nellix system effectively excludes the aneurysm sac and more closely mimics what we do in open surgical procedures, but without the associated risks. It is an important advance in endovascular AAA treatment with the potential to reduce post procedural re-interventions. Our results to date have been very encouraging and we are pleased to have the first patient enrolled in this pivotal study. The Nellix EVAS System performed as we expected; effectively sealing the patient's aneurysm with a simple and predictable endovascular procedure."

    The Nellix EVAS system is a new generation of abdominal aortic aneurysm ("AAA") therapy designed to seal the entire aneurysm. Nellix is the first and only EVAS product and was developed to simplify procedures, reduce re-interventions and expand the treatable patient population. Endologix received CE Mark for the Nellix EVAS System in the first quarter of 2013 and the limited commercial release of the product in Europe is currently underway.

    The EVAS FORWARD-IDE is one of a number of clinical studies that make up the broader EVAS FORWARD Clinical Program aimed at establishing clinical and economic evidence for EVAS using Nellix.

    John McDermott, Chairman and Chief Executive Officer for Endologix, said, "The beginning of enrollment in the EVAS FORWARD-IDE clinical trial is a positive milestone for the Company as we continue to expand our innovative portfolio of endovascular aortic devices. The experience in the first IDE procedure matched our expectations based on our international clinical trial results and early commercial results in Europe. Based on the anticipated enrollment timeline and one-year follow up period, the Nellix EVAS System could potentially be available to physicians and patients in the U.S. by the end of 2016."



  • Fuente: endovascular.es