BioSpan® segmented polyether urethane (SPU) is a critical biomedical polymer used in the majority of clinical ventricular assist devices and artificial heart cases worldwide. It is one of the most extensively tested biomedical polymers on the market, backed by a comprehensive FDA Master File. BioSpan® is the most elastomeric biomaterial available that simultaneously exhibits an impressive combination of physical and mechanical properties together with biological compatibility, characterized by:
The Polymer Technology Group, Inc. (PTG) developed BioSpan® segmented polyurethane in response to the crisis created by the withdrawal of Biomer™1 by Ethicon Inc. Although BioSpan® was designed as a direct replacement for Biomer, PTG made several improvements to the manufacturing process, including scaling up the reaction from 5 to 100 gallons, using glass-lined reaction vessels and depth filters that minimize contamination and implementing rigorous quality control and documentation of the manufacturing procedures. As a result, PTG consistently produces BioSpan® batches of precise molecular structure. This consistency, combined with an extensive FDA Master File, has facilitated the approval process for clinical applications of BioSpan.
For device components that require high strength, flexibility, and fatigue resistance, BioSpan® should be considered as a candidate biomaterial*. Whereas typical urethanes lose stability with increasing soft segment concentration, BioSpan® SPU has excellent physical properties at nominal 70A Shore hardness.
In addition to the proven BioSpan® polymer, PTG also offers experimental grades and variations of BioSpan® with a variety of bulk and surface properties to satisfy specific requirements. For example, BioSpan® C has an aliphatic polycarbonate soft segment that may impart additional oxidative stability to long-term implants, such as pacemaker leads, catheters, and stents, where metal oxide-induced oxidation (MIO) is a potential degradation mechanism. Variations of BioSpan® and BioSpan® C are also available with surface properties similar to silicone, fluorocarbon, polyethylene oxide, or hydrocarbon polymers. By incorporating PTG's proprietary Surface-Modifying End Groups (SME™), desirable surface properties may be obtained, including reduced coefficient of friction, improved abrasion resistance, thromboresistance, and control of wettability. PTG has also developed and patented a new generation of BioSpan® that incorporates silicone into the soft segment, thus delivering the biocompatibility and stability of silicone to an extremely soft biomaterial with unique bulk properties.
1 Biomer is a trademark of Ethicon Inc.
*Disclaimer The user must perform any pertinent tests to determine the product's performance and suitability in the intended application. Final determination of fitness of the product for any particular use is the responsibility of the user.