Elasthane™ TPU Receives FDA Approval for Long-Term Implantable Devices
Berkeley, CA - November 19, 2001 - A major medical device manufacturer recently received FDA approval for the use of Elasthane™ 55D and 75D thermoplastic polyetherurethane (TPU) in high- and low-voltage leads. The approval took less time than expected, and is a significant achievement for the company, which has been seeking a replacement material for Pellethane® TPU1 in these applications. The approval process to use Elasthane™ TPUs in Japan and Australia is ongoing.
The Polymer Technology Group, Inc. (PTG) developed Elasthane™ in response to Dow's decision to limit Pellethane's use in chronically-implanted medical devices. In developing Elasthane, PTG invested in the same continuous reactor technology used by Dow to offer the only Pellethane substitute with the same high molecular weight and reduced thermal history as Pellethane. PTG also implemented rigorous quality control and documentation of the manufacturing procedures, formula optimization, and precision feed pumps. Formal validation of Elasthane™ was accomplished through rigorous short- and long-term testing in conjunction with a major academic institution and a medical device company. Elasthane™ is also backed by a comprehensive FDA Masterfile.
Elasthane™ demonstrates an impressive combination of mechanical properties and biological compatibility, such as exceptionally smooth surfaces, fungus resistance, good biocompatibility, good biostability, low extractables, and hydrolytic stability. Numerous medical devices and technologies have benefited from this combination, including pacemaker lead insulation, artificial heart valves, and cardiac assist devices. Elasthane™ resins also have excellent electrical properties, and are stable to dry heat as well as EtO and gamma sterilization.
The Polymer Technology Group was founded in 1989 by Robert Ward, who is a recognized pioneer in the field of biomaterials and the company's CEO. PTG specializes in the research, development, scale-up, and manufacture of new polymers, medical devices, and components. PTG's commercial product portfolio also includes two of the world's most extensively tested biomaterials in clinical use today, BioSpan® segmented polyurethane and Bionate® polycarbonate urethane. In addition, PTG offers custom-fabricated components from our patented PurSil® silicone polyether urethane and CarboSil® silicone polycarbonate urethane. PTG's 32,000 square-foot facility houses the equipment and expertise to support production-scale polymer synthesis through contract medical device manufacturing.
CONTACT:
The Polymer Technology Group, Inc.
2810 7th Street
Berkeley, California 94710
Phone: 510-841-8800
Fax: 510-841-7800
http://www.polymertech.com
info@polymertech.com