Noticias

Noticias

  • Título: ANCHOR Postmarket Registry Data Presented for Aptus’s Heli-FX EndoAnchor EVAR System
  • Fecha: 08-10-2013

  • Sunnyvale, CA, October 8, 2013—Aptus Endosystems, Inc., a medical device company pioneering solutions to enhance aneurysm repair, today announced positive initial results from its ANCHOR post-market registry evaluating the use of the Heli-FX™ EndoAnchor System in endovascular aneurysm repair (EVAR). Heli-FX is a mechanical fastening device that connects the endograft to the aorta and is designed to enhance the long-term durability of the procedure and reduce the risk of repeat interventions in EVAR. These early results from the first 250 patients demonstrate the safety and acute technical success of utilizing Heli-FX in primary and revision EVAR procedures. These data were presented for the first time by James Joye, D.O., interventional cardiologist at El Camino Hospital, at the 11th VIVA conference held in Las Vegas, Nevada on October 8–11, 2013.

    “EVAR has become the standard of care in aneurysm repair despite shortcomings in long-term durability resulting from issues often encountered in maintaining proper sealing and fixation of an endograft to the aorta, especially in challenging anatomies,” said Dr. Joye. “These initial ANCHOR results show the potential for a definitive solution to a long-standing limitation in EVAR. Further study and long-term data will determine if Heli-FX is able to reduce aneurysm-related adverse events, reduce the need for secondary interventions, and will assess the need for long-term follow-up.”

    ANCHOR (Aneurysm Treatment Using the Heli-FX™ Aortic Securement System Global Registry), a global, multicenter, prospective post-market registry, evaluates the use of the Heli-FX system in EVAR and captures critical data on the use of the technology as well as acute and long-term procedural outcomes. Initial results from the registry showed:

    • Acute safety and efficacy results with Heli-FX;
    • Heli-FX is used in conjunction with a variety of endografts and in both primary and revision EVAR procedures, with primary prophylactic use outweighing revision cases by approximately three to one;
    • Heli-FX was used in revision procedures to repair Type 1 endoleaks or endograft migration in patients with previously placed endografts with 91% acute technical success.

    “The ANCHOR registry has been enrolling fast thanks to strong support from our physicians, and we are pleased to share these initial, early results,” said James Reinstein, president and CEO of Aptus Endosystems, Inc. “Especially interesting has been the high percentage of patients who have received Heli-FX prophylactically, showing that in the real world setting, physicians are concerned with the long term results of patients who have difficult proximal neck anatomy.”



  • Fuente: endovascular.es