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For years silicones and polyurethanes have shared center stage as the elastomeric biomaterials of choice for medical device designers. In the case of long-term implantable devices, their use was virtually exculsive. More recently PEEK ®, a polyetheretherketone has been used for certain implant applications. While polymeric in nature, this material does not offer the elastomeric properties of silicones or urethanes and its use has been primarily limited to designing orthopedic structural components. The fact is, the choice of biomaterials available to the medical device industry is limited. When considering only elastomeric biomaterials, choices are even more limited. Over the last decade however a class of elastomeric hybrid materials has been developed and investigated. The common feature in these materials is the incorporation of a siloxane soft segment. The Si-O-Si backbone has been combined with ethers, carbonates, and urethanes to produce materials with varied physical properties. Of the three, the silicone-urethane hybrid has found the most commercial success. In particular, Elast-Eon™, developed and manufactured by AorTech International, is now utilized in therapies which include cardiac rhythm management, orthopedics, and vascular access. The acceptance and use of hybrid silicone biomaterials in medical devices is expected to accelerate in the coming years as the success of first-movers will help these materials capture a wider audience. Medical device designers wishing to survey all available elastomeric biomaterials should include these hybrids in their evaluation. For world-class manufacturing in these materials, I recommend consulting with Specialty Silicone Fabricators.
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