Here’s what you need to know.
1. The LC Bead device received FDA approval as an embolic device that can be placed in blood vessels to block or reduce the blood flow to tumors. Distributors marketed the device as a drug-device combination product and or for use as a drug-delivery device or “drug-eluting” bead. It was not approved as any of the three.
2. Through the settlement, Biocompatibles will pay $8.75 million for the misbranding of the LC Bead along with a forfeiture of $2.25 million. It will then pay $25 million to resolve all civil allegations under the False Claims Act.
3. In 2004, the FDA required Biocompatibles to assure the agency it would not market the device for drug delivery. Biocompatibles agreed saying it would not market the device as such “under no circumstance.”
In 2006, Biocompatibles began marketing the LC Bead for drug delivery in the U.S.
In December 2009, the company attempted to gain FDA approval of the device as a drug-eluting bead combination product. The FDA said there was not adequate evidence of a therapeutic benefit.
Distributors of the device continued to market it as a “better” or “superior” form of treatment without any evidence to support the claims.
4. Biocompatibles. is a subsidiary of London’s BTG Interventional Medicine. BTG released a statement saying the device was being wrongly marketed before it acquired Biocompatibles in January 2011.
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