By Liz White, UT editor
London-AorTech International plc recently announced the first approval for human use of its polymer technology Elast-Eon by the influential US authority the Food and Drugs Administration (FDA).
Elast-Eon is a biocompatible silicone/urethane elastomer developed by Australian scientists.
"This event represents another significant step forward in the development of the company and the validation of the Elast-Eon technology," said Frank Maguire, AorTech ceo, in a company statement.
This development follows an exclusive license agreement signed in March this year between Aortech and St Jude Medical's Cardiac Rhythm Management Division for the use of Aortech's Elast-Eon material in cardiac rhythm management leads.
Aortech is a developer of medical devices and biomaterials, and also licenses intellectual property in this field.
As well as the direct benefit of earnings from sales of Elast-Eon sales, the start "of the human use phase will provide valuable credibility for Elast-Eon as we expand its use into other medical markets," Maguire added.
Aortech gives a figure of over £4500 million ($8500 million) for the annual value of the global market for cardiac pacing and intensive care devices. This sector also grew by about 8 percent in 2005, Aortech said.
The company, which has a UK base in Strathclyde in Scotland and manufacturing operations in Melbourne, Australia, said it also expects clinical use of Elast-Eon in orthopaedic and urology markets under separate licenses over the next year.
* Separately, the company has announced that it has appointed a Medical Advisory Board, bringing what it calls, "Key opinion leaders in breast plastic surgery," on board.
AorTech has enlisted two US plastic surgeons, Leroy Young MD, and Mark Jewell MD as advisors. Between them, they have eighty years' combined experience in plastic surgery.
AorTech said its Medical Advisory Board will "play a key role in the development and promotion of AorTech's unique and highly versatile Elast-Eon product, in a range of surgical applications."