Balts Certifieringar och registreringar

Balt´s quality certificates and international registrations:

  • ISO 9001 (2000)
  • NF EN ISO 13485 (2004)
  • Directive Européenne 93/42/CEE
  • Foods and Drugs Administration FDA- USA (some products only)
  • TGA – Australia
  • KFDA – Korea
  • HEALTH CANADA
  • PMDA – Japan

Quality is one of BALT’s main focus

The Balt quality is the continuous research on products more user-friendly, simple and always more reliable in its use. The pillar to this adequacy with clinical practicians’ gestures is that Balt always pays particular attention to its devices users’ opinion.

The quality of Balt products is also a steady research on materials and manufacturing methods. The quality of Balt products reveals not only a consistent manufacturing, a strict unit control and quality assurance procedures for each manufacturing step. It is also a firm certainty in a rigorous control of raw materials, biocompatibility and apyrogenicity.

Finally, Balt’s quality is the key element to the ongoing policy of improvement brought to extrusion, injection & assembling methods. Manufacturing staff of 50 people is being permanently trained in order to guarantee Balt’s performance and the quality of its devices.

Main BALT technical innovations

  • 1982 - PURSIL

    Polymers alloy allowing the production of flow-dependant tubes.

  • 1986 - CRISTAL BALLOON

    Catheters for angioplasty and valvuloplasty. BALT is the only one to produce balloons with diameter up to 40mm.

  • 1987 - MAGIC

    First flow-dependant catheter.

  • 1993 - MDS

    First mechanical detachment system of coils for aneurysms embolization.

  • 1996 - HYDROSPEED

    Hydrophilic treatment improving significantly the catheters and microguidewires sliding.

  • 1997 - SORCERER

    Creation of the smallest intracerebral micro guidewire in the world, the SORCERER.007” (Ø 0,18mm). 
    The core of this guidewire uses a new material with shape memory: Nitinol, alloy of Nickel and Titanium.

  • 1998 - VASCO

    Multilayers braided catheter with an inner coating of low friction.

  • 2000 - BOA

    Balloon-expandable intracranial stent. The BOA is the first and the single one solid platinum stent in the world.

  • 2002 - CORAIL

    Balloon-tipped guiding catheter 6F or 8F.

  • 2003 - LEO

    First self-expanding intracranial repositioning stent.

  • 2004 - GOLDBALLOON

    Latex detachable balloons with quick mounting.

  • 2005 - CATCH

    First efficient intracerebral thrombo-embolectomy system.

  • 2005 - MDS Pression

    MDS modification: development of a hydrodynamic detachment system of MDS coils, 
    creation of the longest coils in the world.

  • 2006 - SONIC

    First microcatheter with a safety system Fusecath allowing its distal part to come away.

  • 2006 - STEEL

    Range of guidewires with steel structure.

  • 2008 - SILK

    Flow diversion device for intracranial vessels.

  • 2009 - FARGO

  • 2010 - HYBRID

  • 2011 - COPERNIC8x80RC, COPERNIC10x80RC

  • 2012 - LEO BABY

  • 2012 - CATCH+

  • 2013 - FARGOMINI

  • 2015 - ECL2L, COP2L

  • 2018 - OPTIMA COILS

  • 2018 - SQUID 34

  • 2018 - CATCH VIEW

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