Optimize the safety, biocompatibility and performance of your implantable medical devices
The implantable medical devices used across application areas including cardiovascular disease, orthopedics and wound healing continue to become more specialized and personalized. One key enabling factor driving this market evolution is the development of advanced biomaterials that can optimize the medical device safety, biocompatibility and performance. As a global leader for biomaterials with a broad portfolio of products, technologies and services, Evonik has served as a development partner and solutions provider to many of the world’s largest and most innovative medical device companies for more than 30 years. This portfolio includes a range of bioresorbable polymers, surface modification technologies, and services relating to custom polymer synthesis, and the development and scale-up of medical device parts to match your specific application requirements.
The RESOMER® portfolio of biodegradable polymers for implantable medical devices
RESOMER® is the world’s leading brand of bioresorbable polymers for use with implantable medical devices, with more than 30 years of safety and supply security. The breadth and versatility of RESOMER® polymers make them ideal for use across a broad range of orthopedic, vascular, wound closure and other medical device applications. Degradation profiles can span from a few weeks to more than four years, with Inherent Viscosities (IV) from less than 1 to 6 or more dL /g. The portfolio of polymers for medical devices includes a range of standard and custom grades of homo-polymers, copolymers and block co-polymers including lactide, glycolide, trimethylene carbonate, p-dioxanone and ε-caprolactone. A range of filaments and powders are also available for use in the high-resolution 3D printing of implantable medical devices using Selective Laser Sintering (SLS) and Fused Filament Fabrication (FFF) technologies.
Make us your medical device CMO partner for custom polymer synthesis projects
We are leveraging more than 60 years of market leadership in the design, synthesis, and supply of high-quality polymers to provide medical device companies with a safe and reliable choice for the outsourcing of their proprietary biomaterials. From our medical device centers of excellence in the U.S. and Germany, we can offer an integrated range of CMO services from initial scale-up through to large-scale commercial production. Due to our deep understanding of polymerization processes, we can provide extremely tight specification ranges for your proprietary polymers down to an IV ± of 0.01 dL/g. With polymerization and purification processes harmonized across both sites, medical device customers can also benefit from an attractive range of dual-sourcing options. When combined with other application development services available at these and other global sites, we can serve as a single partner for the production of your proprietary excipient, and the development of the final medical device part until it is in your hands.
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Endexo® surface modification technology to improve medical device functionality and safety
Endexo® is a proprietary additive technology that enhances the biocompatibility of medical devices that come into contact with blood, tissue or other biological fluids. The low molecular weight fluoro-oligomers used in Endexo® are incorporated during the device manufacturing process and migrate to within nanometers of the surface. By suppressing procoagulant protein conformation, decreasing platelet adhesion and inhibiting platelet activation, the Endexo® technology reduces the risk of thrombotic events. It also suppresses bacteria adhesion and biofilm formation to reduce infection risk. Commercially proven and compatible for use with a range of base polymers and manufacturing techniques, Endexo® represents a simple, value-based surface modification technology that is suitable for use across a wide range of medical device applications.
Application technology services for implantable medical device projects
Evonik has decades of expertise in the design and production of functional biomaterials suitable for implantable Class II and III medical devices. Our Medical Device Competence Center in the U.S. and Application Labs in Germany and China ensure responsive and reliable project execution. Our technical knowhow and integrated range of services can help to not only reduce complexity but accelerate speed to market and enhance the performance of your medical device. Services are available for use across a wide range of medical device applications including polymer synthesis and design, polymer processing, feasibility samples including rapid 3D prototyping, analysis and characterization. Regulatory data and other medical device support is also available.
The biomaterials portfolio and medical device knowhow to address your specific application needs
Evonik has decades of expertise in providing medical device customers with the outcomes they require across a range of application areas.
- For orthopedic applications such as interference screws, we can help to optimize properties including insertion torque, bone ingrowth, osteo-conductivity and minimize inflammation.
- For cardiovascular applications such as bioresorbable stents, we can enhance properties including radial strength, ductility and scaffold thickness, or together with surface modification technologies reduce thrombosis and infection risk.
- For wound healing applications such as sutures and clips, we can provide property solutions to accelerate degradation, increase strength and durability, or enhance dimensional stability.
Additional areas of medical device application expertise include dental mesh, soft tissue fillers and tissue engineering scaffolds.
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