DEVELOPMENT AND MANUFACTURE OF MEDICAL PRODUCTS FROM POLYTETRAFLOROETHYLENE

DEVELOPMENT AND MANUFACTURE OF MEDICAL PRODUCTS
FROM POLYTETRAFLOROETHYLENE (ePTFE)

рус

ECOFLON ® - VITAFLON ® POLYTETRAFLOROETHYLENE IMPLANTS

Nowadays more and more worldwide attention is paid to PTFE implants production intended for various fields of surgery.
      Polytetrafluoroethylene is one of the most outstanding polymers possessing a unique complex of excellent physico-mechanical, chemical, electric properties. The stuff is corrosion proof, hostile environment and high/low temperature drop inactive.
      Products made of this stuff provided a unique method and equipment being applied differ by a specific porous network represented by nodes interconnected by fibrils. The said node and fibril structure is characterized by a substantial amount of porosity constituting up to 90%, also by flexibility, plasticity, and reliability according to stretching direction.
      The JSC "ECOFLON" staff possesses a profound experience in processing polytetrafluoroethylene. Thanks to their efforts unique properties of the material were considered and implemented in implants intended for different surgeries.
      A few companies in the world can afford manufacturing medical porous PTFE implants as the production process demands experts qualified in this specific field; and is sophisticated and multistage. Equipment and means necessary to provide the production process and to enable control and measurement is not conventional. The company's staff managed to outfit the factory and one would not find similar equipment anywhere in the world.
      Vascular prostheses ECOFLON ® (VITAFLON ® as well) of porous PTFE intended for shunting and reconstructing arteries in any anatomic area accessible for reconstructive surgery are in good demand.
      According to the analysis made by the leading experts in cardio-vascular surgery no other material capable to substitute PTFE in vascular prosthesis production is expected to appear in the coming 10-15 years.
      In spite of its porosity the prosthesis wall thanks to hydrophobic properties of PTFE is not penetrable even given high blood pressure, and at the same time it is easily accessible for body tissues and the growth through walls and forms an inside covering (pseudointima) which is a reliable connection between the prosthesis and body tissues. There is no necessity to soak prostheses in blood prior to surgical process. They are softer than textile ones and property wise they are closer to authentic ones.
      An easy way to perform vascular anastomosis is enabled due to PTFE material used for vascular grafts as they differ from the other types by low surgical porosity and better biologic compatibility with live body tissues, they are thrombosis resistant compared with prostheses made of Dacron, lavsan and other present day materials applied to manufacture well known synthetic vascular prostheses.
      ECOFLON ® prostheses are easily accessible, flexible, elastic, kink and twist resistant and also stable being squeezed outside in unfavorable anatomic conditions. The prostheses are known to be easily adaptable to the wall of the vessel subjected to reconstruction in both cases: in case of "end-to-end" anastomosis and in case "end-to-side" anastomosis. There are being manufactured tubular, cone shaped and bifurcated prostheses which may be supplied with external reinforcement represented by a PTFE spiral and specific prostheses required by hospitals and fabricated according to their orders.
      Beginning with 1996 over 30 thousand people in Russia and other countries underwent surgical operations and this way thanks to surgeons and ECOFLON ® prostheses were rescued from complications related to atherosclerosis and enjoy full life.
      Moreover, using a unique experience in PTFE processing "Ecoflon" company involves Russian scientists from different fields like physics, chemistry, medicine, biology and has managed to develop a technological process and equipment for manufacturing other types of medical products of PTFE as well, namely

  • artificial pericardium;
  • cardio-vascular patches;
  • implants intended for hernias treatment of different locations by laparoscopic or other method;
  • membranes to ensure alveolodental regeneration and osseous maxillofacial tissues;
  • implants intended for reconstructive surgery in order to substitute defective osseous tissues;
  • orbital insert implants;
  • implants intended for scleroplasty.

          We consider an original method developed to ensure in vitro a unified, reliably fixed monolayer of endothelium cells lining the inside surface of the prosthesis to be highly profitable. This will make conditions to improve drastically the quality of smaller (dia.<6 mm) and middle size (dia. abt. 8 mm) prostheses.
          Initial experience of ECOFLON ® prosthesis application on different parts of thoracic aorta revealed after aneurism resection showed that the prostheses are suitable for this type of reconstructive procedures in respect of biomechanical compatibility and technical properties. No complications related to the graft were registered.
          JSC Scientific Production Complex "Ecoflon" pays special attention to quality control and reliability of implants, technical and medical tests held at independent organizations in Russia and other countries. Quality test of feedstock, semi manufactured goods and manufactured implants are implemented step-by-step with the help of special control equipment and computers on the basis of the latest domestic and foreign designs and achievements in control sphere (ISO 9001:2000).
          JSC Scientific Production Complex "Ecoflon" got prizes of the RF government, of Saint Petersburg and Russian government standard for original technologies along with new designs, highly qualified staff and production quality.

     

    The general director
    "Research-and-production
    "ECOFLON", Cand.Tech.Sci.          V.E.DIAKOV

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    Russia, 191040, St. Petersburg, Kolomenskaya street, 4a
    Phone/fax: (812) 764 5542, (812) 764 0259
    E-mail: ecoflone@mail.wplus.net
    Http://www.ecoflone.net