By Liz White, UT contributing editorStrathclyde, Scotland-AorTech International plc is moving forward with development of both saline-filled and Elast-Eon-filled breast implants made using its Elast-Eon polyurethane. Although at an early stage, if the programme is successful in meeting US Food and Drug Administration (FDA) stipulations, “this work will give AorTech access to the $600-million dollar global breast implant market,” the company said, in a 2 Nov statement. This move follows a meeting with FDA representatives to present Aortech’s analysis of Elast-Eon specifically for breast implant devices, in accordance with January 2004 FDA Guidance Documents. Recently, the firm has filed new intellectual property for a very soft class of its novel biostable polymer in this application, to replace silicone gel. First generation prototype devices have been produced, Aortech said. Aortech will now start developing both full devices and a manufacturing process for them. This work will run in parallel with the material qualification efforts which are currently underway and will aim to satisfy the FDA’s requirements which will allow clinical trials to be started. Advantages from using Elast-Eon include significant improvements in the safety of breast implants, in particular with respect to rupture and leakage, Aortech claims. Also, the technology can make devices that are softer and more natural than current silicone-filled devices, according to the Strathclyde, Scotland-based firm. It also said the material is more compatible with the imaging technology used in tumour screening. “
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