Medical compounder Teknor Apex Co. and German PVC manufacturer Vestolit GmbH & Co. KG say they are close to developing a new PVC blend that will have anti-blood-clotting properties built into the polymer. The innovation offers patients potentially cheaper and safer treatment for critical procedures like dialysis and heart surgery.
The companies say the technology could help with one of the critical problems with such treatments: When blood is removed from the body, it wants to clot.
To prevent such clotting, patients can have large amounts of anti-clotting agents dumped into the blood, which creates the risk of turning the critically ill into hemophiliacs.
Or, the tubing used in the procedures can be coated with an expensive agent that duplicates heparin, the body's natural anti-clotting agent.
That technology - which is about two years away from commercialization - would protect patients, but would be an ``order of magnitude'' cheaper than traditional anti-clotting coatings, said Peter Galland, medical compound industry manager for Pawtucket, R.I.-based Teknor.
``The coatings are expensive, nonpermanent, and hence capable of being extracted by the blood,'' Galland said.
``Heparinizing the blood results in a patient, who has just undergone a critical procedure, becoming a bleeder capable of unstoppable hemorrhaging at the wound site.''
The Teknor-Vestolit compound, by contrast, would be bound to the PVC as a coextruded inner layer and would not be capable of leaking into the blood. The compound also can be used in catheters and extracorporeal circuits.
The companies announced the technology at the Medical Design & Manufacturing West show, held Feb. 19-21 in Anaheim. They declined to share detailed information about cost or what type of material they are using, other than describing it as a ``blood-compatible copolymer.''
The new material would be compounded with PVC at a ratio of about one part per five parts of traditional PVC.
Minimizing the amount of the copolymer and holding down cost will be key to how widely used the new technology becomes, Galland said.
The material will have clear cost-performance advantages over tubing coated with expensive anti-clotting agents - which is used, for example, for severely ill dialysis patients. But such specialty applications are a small segment of the market, Galland said.
``It's not obvious yet whether it will be well-received in the commodity dialysis marketplace,'' he said. ``Right now they just throw heparin into the blood, which surely isn't good for the patient, but it's the cheapest way to do it.''
The market for sensitive dialysis treatment requires about 10 million pounds of PVC a year, Galland said, while the commodity market is another 20 million pounds.
Vestolit developed the technology, based on work by Professor Marcel Jozefowicz at the University of Paris-Nord, in the early 1990s. The German company approached Teknor about commercializing the compound, and the U.S. firm purchased exclusive worldwide licensing rights.
Radu Bordeianu, head of research for Vestolit, said the company can make the material from commercially available polymers, and has produced it in large industrial reactors. But Vestolit wanted Teknor's worldwide marketing and product development expertise, Bordeianu said.
Galland said Teknor is confident that it will be able to commercialize the material because Vestolit already has done much of the groundwork. The U.S. company wants to run its own tests, and then seek approval from the Food and Drug Administration.
``Our people that have researched this in advance feel it is not going to be an overwhelmingly complicated application for the FDA because the coating processes that have already preceded it have established prior ground,'' Galland said.
The compound also may be better at fighting the growth of bacteria than traditional PVC, but more testing must be done, he said.