FDA WARNING_LETTER - Abiomed, Inc.

The FDA issued a Warning Letter to Abiomed, Inc. on June 10, 2011, for marketing the IMPELLA RECOVER LP 2.5 Percutaneous Cardiac Support System without required marketing clearance or approval. The device's 510(k) clearance was for "partial circulatory support... for periods up to 6 hours."

The FDA's review of promotional materials, including a September 2010 Cath Lab Digest advertisement, a 2010 Transcatheter Cardiovascular Therapeutics meeting presentation, and the company website, revealed claims representing a major modification to the device's intended use and indications. These objectionable claims included comparative statements implying superiority to the intra-aortic balloon pump (IABP), linking increased Cardiac Power Output (CPO) to lower mortality in cardiogenic shock patients, and the tagline "Recovering Hearts, Saving Lives." The FDA had previously informed Abiomed in a January 28, 2010, letter that such comparative statements were inappropriate and violated regulations prohibiting claims of safety and effectiveness for devices under study (21 CFR 812.7(d)). Although the study (G050017) was terminated, the unsupported comparative claims violate 21 CFR 801.6.

These new claims require support from an appropriately designed clinical study under an Investigational Device Exemption (IDE) and a new premarket notification (21 CFR