FDA Warns Abiomed on Unauthorized Heart Pump Marketing
Published: Jun 30, 2011
Shares in Abiomed Inc. (Nasdaq: ABMD) fell Tuesday after the company received a letter from the Food and Drug Administration accusing the company of marketing one of its Impella heart pumps without marketing clearance. Abiomed, based in Danvers, made several “objectionable” claims about the potential uses for the Impella Recover LP 2.5 device, in an advertisement last September in Cath Lab Digest, according to the FDA. “These claims represent a major modification to both the intended use and the indications for use of the device,” the FDA said in the warning letter to the company, dated June 10.