Ulteeva Purity™ - the world’s first medical grade UHMWPE membrane

For years, the medical device industry has relied on expanded polytetrafluorethylene (ePTFE) to create vascular stent coverings and grafts. Now, our customers have the opportunity to use a superior alternative with outstanding biocompatibility and biostability that meets the growing regulatory need for a PFAS-free solution. Called Ulteeva Purity™ membrane, this sustainable UHMWPE solution enables us to help you create tomorrow’s solutions today.

We work with partners worldwide across the continuum of healthcare to create innovative medical devices that bring progress to life for patients everywhere

30+

Years

30+ years of experience working with the world’s leading medical device and pharmaceutical companies.

20+

Years

20+ years of clinical use for our Ulteeva Purity™ polyethylenes.

100+

Years

100+ years’ experience within our polyethylene innovation team.

Why choose our medical grade UHMWPE membrane for your next project?

With a high strength-versus-volume ratio and consistent properties in all directions, Ulteeva Purity™ membrane is ideal for long-term implantation – and miniaturization. This is an extremely thin (16 μm) and breathable material with a microporous structure that’s ideal for device designers striving to improve patency rates in stent coverings and beyond. 

Ulteeva Purity™ membrane also gives you superior dimensional stability in high-motion implantable devices due its high wear and creep resistance; and all with a silky-smooth surface for a low co-efficient of friction. Complementing this, we bring you added peace of mind through:

  • Outstanding safety and sustainability - our polyethylene membrane is halogen and polyfluoroalkyl (PFA) free.
  • Seamless integration with other polymers like Nylon to meet demanding design requirements.
  • Unrivaled regulatory support for the approval of your devices (including biocompatibility and biosafety data), all supported with FDA Master Files.

About Ulteeva Purity™

Discover our Ulteeva Purity™ membrane solutions

 

Key applications

Ulteeva Purity™ membrane is a superior and sustainable alternative to ePTFE for stent coverings and implantable medical devices and is ideal for use in:

  • Cardiovascular stents (including peripheral stents).
  • Biliary stents. 
  • Gastrointestinal stents.
  • Endovascular stents.

 Additional applications

 You can also use Ulteeva Purity™ membrane in the design of: 

  • Drug-eluding stent grafts.
  • Medical filtration applications. 
  • Endoluminal delivery systems.

Application spotlight: Putting Ulteeva Purity™ membrane to the test

“Based on outcomes from angiography, radiography and histology, both test devices and control devices in all four sheep were widely patent (open) at 90 days. “The results of the study were very encouraging and our expectations for further development and uses of the Ulteeva Purity™ membrane in this arena are high.”

  • Dr. Renu Virmani, MD, FACC and President of CV Path Institute

To demonstrate the effectiveness of Ulteeva Purity™ membrane, a team of researchers conducted preclinical studies where a prototype covered stent using our material was compared to a stent featuring ePTFE. 

The results showed a favorable similar/noninferior comparison; with the grafts made from Ulteeva Purity™ membrane remaining widely patent (open). As a result - and just like Dr. Virmani says - we have high hopes for this unique polyethylene membrane in this application.

We create sustainable healthcare solutions that deliver tangible and valuable sustainability benefits to our partners – with no compromises on safety or performance.

Frequently Asked Questions

Here are some common questions our experts get asked. Do you have a different question? Contact us

What is the relationship between Ulteeva Purity™ membrane and Dyneema Purity® membrane?

  • Ulteeva Purity™ membrane is our new brand name for Dyneema Purity® membrane. However, the technology and team remains the same.

How does Ulteeva Purity™ membrane compare to ePTFE in peripheral stent grafts?

  • Our animal data shows peripheral stent graft using Ulteeva Purity™ membrane exhibits rather comparable performance to the ePTFE counterpart. Together with other unique features - including high strength-to-volume ratio, high wear and creep resistance, and easy incorporation of other materials – our polyethylene membrane enables more innovative implantable medical devices with superior performance.

Is Ulteeva Purity™ membrane compatible with stents made from nitinol?

  • Absolutely. In fact, one distinct advantage of our UHMWPE membrane is its low processing temperature (<150 °C) in comparison to ePTFE (>300 °C) during its integration with the stent - which prevents unwanted harm to the nitinol’s properties.  
     

Ulteeva Purity membrane is a relatively new product in the DSM Biomedical portfolio. Is it already used commercially?

  • Yes! Although Ulteeva Purity™ membrane is a relatively new market entrant, we are already seeing its clinical application. For example, a permanent blood-contact endoluminal device is being launched using this polyethylene membrane, with more to come. These include a stent graft (both vascular and non-vascular) and endovascular delivery system - to name a few.

Does the Ulteeva Purity™ membrane fit with future regulations?

  • Yes, compared to PFAS material, polyethylene is far more environmentally friendly and healthy based on both the raw material synthetic chemistry and the UHMWPE membrane manufacturing process. We do not anticipate any future regulation issues for Ulteeva PurityTM membrane – unlike what we now see with PFAS. Furthermore, in contrast to PFAS material, Ulteeva Purity™ membrane can be integrated into medical devices at a much lower temperature with no risk of toxic gas being released - thus further reducing energy consumption and protecting health.

Technical Resources

Looking for more information on how our UHMWPE membrane can help you tackle unmet needs?

Ulteeva Purity™ Brochure                              

Overcoming Challenges With Metal Cerclage Cables                  

We understand that medical product development can be a long, winding - and occasionally bumpy road. Rest assured that at DSM Biomedical, we have the proven experience, capabilities, and knowledge to support you every step of the way. 

It starts with using a form-fit-function approach based on a comprehensive understanding of how the human body reacts to biomaterials following implantation. This in turn enables us to design materials that are compatible with the body’s physiology and help you develop finished products that can sustain, restore, and repair – all supported by applicable regulatory requirements. 

Our expert biomaterials team is here and ready to support you

Discover how we can partner with you to co-create innovative stent coverings with our polyethylene membrane.
 

Need expert assistance?

Our polyethylene membrane experts are here to help.                                                                                                                                                                                  

Explore our other Biomaterials 

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