We work with partners worldwide to create innovative medical devices that support patient healing- and bring progress to life
Medical polyurethanes
Discover how our polyurethanes can enhance your medical device designs
Polyurethanes are renowned for its excellent biocompatibility and decades of successful use in implantable applications. With exceptional tensile strength and elongation properties, this flexible yet highly durable polymer is designed for a variety of medical uses. Its polymer backbone is constructed from building blocks that exhibit outstanding oxidative stability, ensuring reliable performance over time. Easily processed through hot melt extrusion or injection molding, this versatile material is ideal for load-bearing and articulating implants, long-term orthopedic applications, and lead insulation needs.
30+ Years
Of proven clinical use
200K+
Spinal implants annually
14 Million+
Cardiac and neurostimulation leads annually
Why choose our medical grade polyurethanes for your next project?
Specifically designed for long-term implantation in the human body, our medical polyurethanes are ideal for demanding applications like soft tissue augmentation, cartilage repair, and resurfacing implants – as well as glycemic control devices for diabetic patients.
They also bring you further versatility in device design, through tunable bulk properties and surface properties achieved using Surface Modifying End Group (SME®) technology. Complementing all this we bring you added peace of mind through:
- Extensive FDA Master Files for each family of polyurethanes that support US regulatory filings.
- Specialized production capabilities based on an established supply chain; robust quality systems; and a medical grade, ISO-certified manufacturing facility.
Portfolio overview
Discover our solutions for medical grade polyurethanes
Bionate®
Our aromatic polycarbonate-based thermoplastic polyurethanes (PCUs) are tough, with excellent oxidative biostability and abrasion resistance; making them ideal for use in:
- Load-bearing and articulating implants.
- Long-term orthopedic applications.
- Lead insulation applications
Why our Bionate?
Bionate® polyurethanes are tough, aromatic polycarbonate-based thermoplastic elastomers that provide excellent oxidative biostability and abrasion resistance. With a proven track record in implantable applications, Bionate® ensures long-lasting performance and biocompatibility, making it a trusted choice for your medical device.
How can our Bionate be used?
Bionate® polyurethanes are highly versatile and well-suited for a range of medical applications. They excel in load-bearing and articulating implants, providing the durability and flexibility needed for demanding environments. Ideal for long-term orthopedic devices, Bionate® ensures biocompatibility and resilience over time. Additionally, its effectiveness in lead insulation protects medical devices from environmental factors. With applications extending to cardiovascular devices and soft tissue implants, Bionate® offers the flexibility and biostability required to meet the rigorous demands of modern medicine.
Bionate® II
These medical polyurethanes give you a similar performance to Bionate®. Additionally, this product is enhanced with SME® technology, which modifies the surface characteristics to improve manufacturing.
Why our Bionate?
Bionate® polyurethanes are tough, aromatic polycarbonate-based thermoplastic elastomers that provide excellent oxidative biostability and abrasion resistance. With a proven track record in implantable applications, Bionate® ensures long-lasting performance and biocompatibility, making it a trusted choice for your medical device.
How can our Bionate be used?
Bionate® polyurethanes are highly versatile and well-suited for a range of medical applications. They excel in load-bearing and articulating implants, providing the durability and flexibility needed for demanding environments. Ideal for long-term orthopedic devices, Bionate® ensures biocompatibility and resilience over time. Additionally, its effectiveness in lead insulation protects medical devices from environmental factors. With applications extending to cardiovascular devices and soft tissue implants, Bionate® offers the flexibility and biostability required to meet the rigorous demands of modern medicine.
CarboSil®
Our aromatic polycarbonate-based silicone-containing thermoplastic polyurethanes (TSPCUs) combine the biocompatibility and biostability of conventional silicone elastomers with the processability and toughness of thermoplastic polycarbonate-urethanes.
Why our Carbosil®?
Meet the first approved polyurethane for elastomeric drug-eluting stent (DES) coatings, designed to offer exceptional biostability along with flexibility and abrasion resistance. Its polymer backbone is constructed from highly oxidatively stable building blocks, ensuring reliable performance in challenging environments. This versatile material can be processed through hot melt extrusion, injection molding, or solutions-based methods, making it an ideal choice for advanced medical applications.
How can our Carbosil® be used?
Our CarboSil is ideal for use in vascular or orthopedic implantable devices. It has been proven effective in applications ranging from continuous glucose monitoring devices to analyte sensors and neuromodulation devices.
Biomerix
Our aromatic polycarbonate-based thermoset polyurethane (PCPU) provides a unique scaffold with an open-cell, porous structure. This is complemented by:
- Varying compressibility with high void content (90%-95% void area).
- Availability in various shapes and forms; and customization based on your application requirements.
Why our Biomerix®?
Our aromatic polycarbonate-based thermoset is a non-resorbable biomaterial featuring a unique 3D morphology with an open-cell porous structure that promotes biointegration. Highly compressible and with a high void content of 90%-95%, it offers exceptional performance in various applications. Available in three commercial formulations (HF3, HF2, SF3), this biostable material resists hydrolytic, enzymatic, and oxidative degradation, ensuring long-term durability. Additionally, it is biocompatible according to ISO 10993 standards, making it a reliable choice for medical devices and implants.
How can our Biomerix® be used?
Biomerix, known for its advanced biomaterials, can be used in a variety of applications including vascular applications, cardiovascular and orthopedic devices, soft tissue implants, wound care products and drug delivery systems.
Elasthane®
Our aromatic polyether-based thermoplastic polyurethane (TPU) is a durable and abrasion-resistant, workhorse polymer with a 20-year track-record in chronic implants.
Ideal for insulating sheathing in pacing leads (CRM).
Why our Elasthane®?
Our product is specifically designed to support long-term implantation in medical devices. Its high tensile strength ensures durability while maintaining excellent biological compatibility, making it a reliable choice for a variety of applications. Elasthane® can be adapted with SME® technology, enhancing its surface characteristics and processing capabilities. This combination of properties makes Elastane an ideal material for advancing the performance and longevity of your medical implants.
How can our Elasthane® be used?
Our Elasthane® is ideal for insulating sheathing in pacing leads (CRM).
ATPU
For applications that require low processing temperatures, our aliphatic polyether-based thermoplastic polyurethane (ATPU) is the ideal choice, offering:
- A combination of high strength and elongation in temporary implant applications.
- A proven track record in a variety of applications; for example, as an excipient platform for hydrophobic and hydrophilic drug diffusion.
Why our ATPU®?
Our product offers a combination of high strength and elongation in temporary implant applications.
How can our ATPU be used?
Our aliphatic polyether-based thermoplastic polyurethane (ATPU) is perfect for applications that require low processing temperatures. It has been proven effective in a variety of applications including excipient platforms for hydrophobic and hydrophilic drug diffusion.
Biospan® (SPU)
Our segmented polyether polyurethane (SPU) is delivered in a dimethylacetamide solution. It enables extraordinary flex life and is proven to withstand millions of flex cycles.
- Biospan® contains two individual formulations - enhanced with silicone or fluorocarbon surface-modifying end group technology.
- Ideal for cardiovascular applications: including ventricular assist, artificial hearts, and balloon devices.
Why our BioSpan®?
Our product is characterized by its low modulus and high elongation, making it highly flexible for various medical applications. The incorporation of SME® and SAME® functionalities allows for seamless integration without the need for additional surface modifications post-fabrication, simplifying the manufacturing process.
How can our BioSpan® be used?
Our segmented polyether polyurethane (SPU) is ideal for vascular applications including ventricular assist, artificial hearts, and balloon devices.
PurSil® (TSPU)
For the best of both silicone elastomers and polyether urethanes, look no further than our aromatic polyether-based silicone-containing thermoplastic polyurethane (TSPU).
- PurSil® delivers excellent flexibility and oxidative stability.
- Ideal for various medical device applications: including ophthalmic and continuous glucose monitoring.
Application spotlight: Accelerating Rotator Cuff Repairs (RCR)
Currently, options for RCR are very limited to temporary implants that only last a few weeks. In response to the market’s need for a permanent solution, our Biomedical team created a novel and functional prototype for our partner, one of the largest orthopedic device companies in the world.
Frequently asked questions
Here are some common questions our experts get asked. If you have a different question, please contact us.
In what forms are your medical polyurethanes available?
These thermoplastic polymers are supplied as pellets; but also come in solution form. Please contact your dsm-firmenich representative to learn more.
How should the material be stored?
Store our polyurethanes at 15-32°C (60-90°F) in a relatively dry, dark place (due to the hygroscopic nature of this material). If possible, the entire contents of a container should be used at one time. If this isn’t possible, you should put the remainder in a re-sealable container - ideally blanketed with an inert gas (such as dry nitrogen).
How should your medical polyurethanes be processed?
Our polyurethanes can be processed using many thermoplastic methods: including injection molding, extrusion and compression molding. Melt processing conditions are similar to conventional thermoplastic polyurethanes. For more information, download our TPU Extrusion Guide and/or The DSM Injection Molding Guide.
- Filtered solutions of the thermoplastic polymers are suitable for solvent bonding, dipping, coating, spraying, and related solvent-based conversion methods. For more information, contact our team of experts.
How should the polyurethanes be dried before thermal processing?
Proper drying of the pellets is an important first step to ensure efficient thermoplastic processing and the production of high-quality parts. A desiccant-bed-type dehumidifying hopper dryer is recommended, with an inlet air temperature of 80o – 95o C (180o – 200o F) for Bionate®, Bionate® II, CarboSil®, Elasthane®, and PurSil® polyurethanes. For ATPU grades the inlet air temperature should be set to 60o – 80o C (140o – 176o F).
- Drying to approximately 0.01-0.02% moisture can usually be accomplished in 8 to 12 hours. However, the time will depend on the efficiency of your dryer and the amount of material to be dried. The harder durometer materials (e.g. 55D & 75D) may need a drying temperature and time at the higher end of the recommended range.
- The moisture content of medical polyurethanes should be measured by a moisture analyzer immediately before each use. After drying, the material may need to be manually separated (using a gloved hand) before melt processing in order to prevent the throat of the extrusion or injection molding equipment becoming blocked. For injection molding, a dew point reading of approximately -20 to -40°C (-5 to -40°F) on the return air hopper is also a good indicator that the material is ready for processing. Note: We do not recommend over-drying or re-drying polyurethanes as this may cause sub-optimum processing and gels.
How do you sterilize medical polyurethanes?
We recommend Ethylene Oxide (EtO) for sterilizing devices made with polyurethanes, based on published references. Our testing indicated that EtO sterilization has no noticeable effect on the mechanical properties of polyurethane parts. Gamma radiation is another sterilization method for parts made from our medical polyurethanes. In fact, when tested, polyurethanes from dsm-firmenich Biomedical showed no changes in mechanical properties when sterilized by gamma irradiation up to 45 KGray (1 Gray= 1 Joule/Kg). We do not recommend using steam sterilization; although other methods of sterilization may be appropriate, depending on the design of the part. Ultimately, device manufacturers are responsible for verifying the impact of the sterilization process on their products’ performance.
Technical resources
Looking for more information on how our ECM technology can help you tackle unmet needs?
ATPU Product Sheet
Bionate® PCU Product Sheet
Bionate® II PCU Product Sheet
BioSpan® SPU Product Sheet
CarboSil® TSPCU Product Sheet
PurSil® TSPU Product Sheet
We understand that medical product development can be a long, winding - and occasionally bumpy road. Rest assured that at dsm-firmenich 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.
MDSAP ISO 13485
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