DSM have recently introduced a new grade of UHMWPE film for cardiovascular applications. AZoM conducted this interview with DSM to find out more about this new material and its applications.
If you could provide us with a bit of background, what does DSM specialize in?
DSM creates innovative products and services in Life Sciences and Materials Sciences that contribute to the quality of life. Providing a broad portfolio of material based product & technologies that will enable the replacement, repair, enhancement and ultimately the regeneration of tissue and organ function is an important strategic area for DSM. DSM’s current biomedical portfolio includes ComfortCoat™ hydrophilic and antimicrobial coating technology, implant solutions (including Dyneema Purity®) and the drug delivery platform Trancerta™. Recently the company acquired PTG, a market leader in the field of biomedical polymers.
DSM have recently developed a UHMWPE film for use in cardiovascular devices. UHMWPE is currently used in biomedical applications such as in acetabular cups in total hip replacements, which is essentially a wear/orthopedic application. What led you to look at using and developing it for cardiovascular devices, and what benefits does it bring in this application?
DSM is world’s only provider of medical grade UHMWPE fiber, branded Dyneema Purity®. UHMWPE fiber is the strongest fiber available, and is used today in various cardiovascular applications. The extreme mechanical properties have the potential the fiber to reinforce medical devices or make them smaller. Based on this experience, DSM decided to develop a film for medical implant purposes, next to the fiber that is already used in millions of patients. For some applications, for example stent grafts, it can be potentially beneficial to use a two-dimensional film as starting point in order to arrive at a three-dimension design of a medical device. Further, the film has unique tailorable properties, like the film thickness, pore size and porosity. The UHMWPE that is used in acetabular cups that you are referring to is a different form of UHMWPE, namely a resin. The resin is the base material to manufacture both UHMWPE- fiber and UHMWPE-film. The mechanical properties of the fiber, the film and the resin are different.
Is your material chemically the same or similar to the material that we would find in an UHMWPE acetabular cup?
Yes, it is all based on PE technology. However, the processability for the three different materials is different and this gives different mechanical properties and topography.
What particular cardiovascular devices do you envisage your UHMWPE film to be used in, both near term and in the future and is anyone currently using this material to manufacture implantable devices?
We target the use of UHMWPE film for various covered stent applications. The low profile in combination with its mechanical robustness and tailor able pore-size are promising aspects we believe.
Are you are currently looking to offer this material to manufacturers of cardiovascular devices for the design of new products, or perhaps the re-design of existing products?
We offer if for design of new concepts and for redesign of existing products to replace other materials.
Are there other synthetic or naturally occurring biomaterials that have been used for these applications? If so what performance gains have been seen using your UHMWPE material?
Currently several other synthetic materials are used in these markets, such as e-PTFE and polyester. Performance gains that are targeted with the UHMWPE film are low profile combined with high strength and a favorable surface properties. The material is not commercially used yet in the market.
Does your material include any drugs such as antibiotics, anti-inflammatories or anti-rejection agents that help its’ performance/integration?
The inherent porosity of the material can be used to incorporate active ingredients.
How long will your material last in vivo? (Is it designed to breakdown or to be used as a scaffold?) And how long do you expect the performance gains to last?
UHMWPE is non-degrable. Details on the performance in vivo depend on the design and is a question that only a medical device company can answer for their specific design.
Has your material been approved by regulatory bodies like the FDA?
The UHMWPE-film is a raw material. FDA approval needs to be received on the final device and this is the responsibility of the medical device company. The material has been successfully tested in accordance with USP Class VI.
When can we expect surgeons to be offering your UHMWPE material as an option?
We are partnering with medical device companies. It is the freedom of medical device companies how to translate the potential benefits to surgeons and patients.
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