Teknor Apex: Vinyl compounds prevent blood clotting in medical devices

An agreement signed this month by Teknor Apex and polyvinyl chloride (PVC) manufacturer VESTOLIT GmbH & Co. KG grants Teknor Apex exclusive worldwide rights to develop and produce vinyl compounds based on new copolymers with blood clot-preventing molecules incorporated directly into the PVC polymer backbone, it was announced today by Teknor Apex, Vinyl Division, during MD&M West.

In tubing, catheters, extracorporeal circuits, and other medical devices, the compounds will provide substantial cost-performance advantages over the anti-clotting (anti-thrombogenic) coatings currently applied to the inner surfaces of such devices, according to Bertram M. Lederer, senior vice president of Teknor Apex. ‘By increasing the reliability of devices that process living blood during critical medical procedures, the compounds based on VESTOLIT’s new resins will benefit the healthcare industry and even have the potential to save lives.’

Unlike standard anti-thrombogenic coatings, the bioactive components in VESTOLIT resins are permanently affixed to the PVC backbone and are non-extractable, according to Peter M. Galland, industry manager for Teknor Apex. ‘While compounds based on these specialized copolymers will cost more than standard medical-grade vinyl, device manufacturers can minimize costs by co-extruding the compounds onto standard vinyl in thin layers. As a result of limiting the bio-active compound to a thin inner layer and allowing the bulk of the wall of the device to consist of conventional medical PVC, the overall material cost will rise by less than the added cost of current coating methods.’

The tendency of blood to clot or coagulate when it contacts foreign objects poses a problem in procedures like open heart surgery, dialysis, platelet collection, wound drainage, and insertion of catheters into arteries and veins. The bioactive components of the copolymers
developed by VESTOLIT simulate the anti-thrombogenic messages generated in the lining of
blood vessels by the naturally occurring substance heparin.

‘Drawing on decades of experience manufacturing medical-grade vinyl, Teknor Apex will develop and produce compounds that perform this critical function in the lining of medical devices without compromising other properties that have made vinyl the most widely used and trusted thermoplastic for healthcare products,’ said Galland.

Agreement Gives Teknor Apex Assured Resin Supply and Access to Technology
Under the agreement with VESTOLIT, Teknor Apex has acquired world-wide rights to use the new PVC resins in vinyl compounds and to market them as Teknor Apex products, according to Lederer. ‘This exclusivity includes access by Teknor Apex to supplies of the resin and to technical data concerning it. The agreement provides for continuing technology interchange between the two companies to further this process.’

Teknor Apex expects to have anti-thrombogenic compounds ready for commercialization in about two years.

Development of the resins on which these compounds will be based was a natural extension of VESTOLIT’s ‘preference for more specialized PVC products,’ said Dr. Radu Bordeianu, head of research for the German-based PVC manufacturer. ‘In the early 1990s, VESTOLIT’s quest for new, unconventional vinyl chloride-based materials led to a cooperative research venture with Prof. Marcel Jozefowicz, then of the University of Paris-Nord, in the area of blood-compatible copolymers with anti-coagulant properties,’ Bordeianu said. ‘After years of intensive research, we succeeded in synthesizing a copolymer which, in vitro, shows remarkable anti-coagulant and bacteriostatic properties.’

For further development and world-wide marketing of products based on this patented innovation, VESTOLIT searched for ‘a competent and experienced ally,’ according to Robert Bornhofen, CEO of VESTOLIT. ‘We selected Teknor Apex as a partner because they enjoy an excellent reputation in the field of compounds for medical devices, and we are confident that this joint effort will further consolidate the pre-eminent position of PVC in medical applications.’

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