The FDA sent a warning letter to Abiomed, dated June 10, concerning marketing practices of its Impella Recover LP 2.5 percutaneous cardiac support system, which the agency said is in violation of the Federal Food, Drug and Cosmetic Act.
The Danvers, Mass.-based Abiomed, according to the FDA, obtained the following 510(k) clearance for the device: for “partial circulatory support using an extracorporeal bypass control unit, for periods up to six hours. It is also intended to be used to provide partial circulatory support (for periods up to six hours) during procedures not requiring cardiopulmonary bypass. The Impella Recover LP 2.5 also provides pressure measurements which are useful in determining intravascular pressure.”
However, the Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed an advertisement, labeling pieces and Abiomed’s website. The FDA review suggested that Abiomed is making claims that were “inappropriate,” and the claims represent a “major modification to both the intended use and the indications for use of the device.”
The objectionable claims include the following:
- An advertisement in the September 2010 issue of Cath Lab Digest shows a hand puncturing a red balloon with a pin. Printed on the balloon is text that reads, “Old ideas about heart recovery.” The caption below the balloon reads in part, “After 40 years, there is something other than the intra-aortic balloon [pump] (IABP) for circulatory support in the Cath lab . . . Cardiac Power Output (CPO) is the #1 correlate to mortality for acute MI (AMI) in cardiogenic shock patients . . . In the latest USPELLA registry, the CPO of shock patients was observed to increase 120 percent from 0.5± 0.2 prior to Impella to 1.1±0.2 on Impella (p=0.02).”
The FDA said that “comparative statements can be interpreted as efficacy statements regarding the superiority of the Impella Recover LP 2.5 to IABP. When we sent you the January 2010 letter, Abiomed had an ongoing investigational device study, G050017, and we advised your firm that the claims violated the regulations at 21 CFR 812.7(d), which prohibit the representation that a device is safe and effective for the purposes being studied. Although the study has since been terminated, the unsupported comparative claims violate 21 CFR 801.6.”
Also, noted as objectionable claims are:
- On page nine of Abiomed’s presentation to the 2010 Transcatheter Cardiovascular Therapeutics (TCT) meeting, the company claimed that use of the Impella Recover LP 2.5 in AMI shock patients improves hemodynamics, and on page 10, it stated that the use of the Impella Recover LP 2.5 improves cardiac output, which is then linked to lower mortality rates, according to the FDA. “Both of these indications would need to be supported with an appropriately designed clinical study performed under an investigational device exemption (IDE),” the agency said.
- Finally, on Abiomed’s website and in the aforementioned advertisement, the logo includes the tag line, “Recovering Hearts, Saving Lives,” which according to the FDA, is “another claim that would require a randomized clinical study performed under an IDE specifically to evaluate whether the device could salvage heart tissue and muscle.”
The FDA concluded that it will evaluate the information submitted by the company and decide whether the firm’s product may be legally marketed. The Office of Compliance also requested that Abiomed immediately cease to market the Impella Recover LP 2.5 for unapproved uses.