The Food and Drug Administration has approved AorTech International P.L.C.'s Elast-Eon silicone/urethane elastomer for human use, the London-based firm said.
``This event represents another significant step forward in the development of the company and the validation of the Elast-Eon technology,'' said AorTech CEO Frank Maguire in a prepared statement.
This development follows an exclusive license agreement signed in March between AorTech and St. Jude Medical's Cardiac Rhythm Management Division for the use of Bartech's Elast-Eon material in cardiac rhythm management leads.
AorTech is a developer of medical devices and biomaterials and licenses intellectual property in this field.
Besides the direct benefit of earnings from sales of Elast-Eon, the start ``of the human use phase will provide valuable credibility for Elast-Eon as we expand its use into other medical markets,'' Maguire said.
AorTech estimates the value of the global market for cardiac pacing and intensive care devices at more than $8.5 billion annually. This sector grew by about 8 percent in 2005, AorTech said.
The company, which has manufacturing operations in Melbourne, Australia, said it also expects clinical use of Elast-Eon in orthopedic and urology markets under separate licenses over the next year.
Separately, the company appointed a Medical Advisory Board, bringing what it calls, ``key opinion leaders in breast plastic surgery'' on board.
AorTech has enlisted two U.S. plastic surgeons, Leroy Young and Mark Jewell, as advisers.
Between them, they have 80 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.''