Noticias

Noticias

  • Título: Two-Year MIMICS Data Show Long-Term Patency for Veryan’s BioMimics 3D Stent
  • Fecha: 03-02-2014

  • Leipzig, Germany, 6 February 2014 – Two-year follow-up data presented atthe annual Leipzig Interventional Course (LINC) have shown that a nitinol stentwith unique three-dimensional helical geometry, BioMimics 3D™, developed byVeryan Medical Ltd, (Horsham, UK) provides an improvement in long-term patencycompared to a straight nitinol control stent in patients undergoingfemoropopliteal artery intervention for symptomatic peripheral arterialdisease.

    The MIMICS studyis a prospective, 2:1 randomised controlled trial, conducted at eight Germaninvestigational centres, with an independent imaging core lab, comparing thesafety and efficacy of the BioMimics 3D™ stent with a straight nitinol stent(92% of subjects in the control arm were treated with Bard LifeStent).

    The BioMimics 3Dstent features unique 3D helical centreline curvature to help the stentedartery mimic the natural biomechanical performance of the femoropoplitealduring knee flexion and extension. This stent is also designed to promoteswirling blood flow and elevated wall shear stress in the stented segment,which preclinical studies have shown to significantly reduce the formation ofneointimal hyperplasia, potentially conferring a patency protective effect.

    Data presented byPrincipal Investigator Professor Thomas Zeller, Universitäts-Herzzentrum,Freiburg-Bad Krozingen, Germany, on behalf of the MIMICS investigators, showedthe Kaplan Meier (KM) survival analysis of freedom from loss of primary patencyat two years was 75.6% for BioMimics 3D subjects vs. 56.0% for the controlgroup (P=0.06). In line with the preclinical observations, the preliminarytwo-year data from the MIMICS study point to a correlation between primarypatency and stent curvature, measured using bi-planar X-ray imaging in straightand bent knee positions. BioMimics 3D stented segments showed greater curvaturein knee extension (P=0.02) and flexion (P=0.02) compared with the control,providing a basis for improved haemodynamics that may underlie the longer termpatency protective effect seen with BioMimics 3D. No stent fractures have beendetected by the study core lab.

    “The latest24-month data for patients treated with the BioMimics 3D stent continue tosuggest that the flow effects produced by its helical design are contributingto an improved outcome compared to that achieved with the straight controlstent. The KM curve for freedom from loss of primary patency with BioMimics inthe 12-24 month period shows separation from that of the control stent, withthe prospect of a statistically significant difference once the few remainingsubjects are assessed over the next two months”, commented Professor Zeller.

    “Data from the24-month assessment visits in the MIMICS Study are continuing to provide ahighly favourable and competitive foundation for BioMimics 3D commercializationand for further clinical investigation to support Veryan’s US strategy”, addedVeryan Chief Executive Chas Taylor.

    “We anticipatethat the full 24-month data set will be available in April 2014.”

    Veryan hasreceived CE Mark approval for the BioMimics 3D stent.



  • Fuente: endovascular.es