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Greystone Associates

New survey examines potential for drug-coated devices

Published in FDA Law Weekly, November 18th, 2004

Advances in coating technology have given rise to a new generation of coating formulations that can reliably deliver therapeutic substances from the surface of an implanted medical device.

In currently approved products, these devices (e.g., coronary stents) provide a primary function, with the drug contributing therapeutic benefit that improves patient outcomes.

Ongoing improvements in specialty coating platforms are expanding the number of active compounds are can be formulated as drug-device combination products.

"We expect the clinical results from the current generation of coated device designs to yield valuable insight that...

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