Heart device maker Abiomed says FDA ends probe

Heart device maker Abiomed says FDA ends probe of improper marketing of 1 its products

Associated Press

DANVERS, Mass. (AP) -- Heart device maker Abiomed Inc. said Wednesday that U.S. regulators have wrapped up a 20-a-month investigation into improper marketing of one its products, notifying the company that the case has been closed after evaluating the company's corrective actions.

The news, announced after stock markets closed, sent Abiomed shares up nearly 6 percent to $14.95 in after-hours trading.

In June 2011, the Food and Drug Administration sent Abiomed a warning letter stating that it was marketing a heart-pumping device for unapproved uses and making unproven claims about its benefits.

The product is called the Impella Recover LP 2.5 Percutaneous Cardiac Support System. It's a tiny device inserted in the left ventricle, the heart's main pumping chamber, to draw blood from there up into the aorta, the huge artery that distributes blood to the body.

According to the FDA's 2011 warning letter, the device was approved for use for periods up to six hours and in limited circumstances.

However, FDA's review of the company's promotional materials, website and a presentation at a 2010 conference on heart devices "indicate that Abiomed is making claims that we stated were inappropriate in a January 28, 2010 letter to your firm."

Among other "objectionable claims" cited in the FDA warning letter were "comparative statements ... regarding the superiority of the Impella" to a different technology and a claim the device improves the heart's output of blood, "which is then linked to lower mortality rates." At the time, the company's logo on its website read, "Recovering Hearts, Saving Lives," which the FDA wrote was a claim that can't be made without evidence from a patient study.

Abiomed, based in Danvers, Mass., said in a statement Wednesday that a letter from the FDA's Office of Compliance indicated the concerns cited in the 2011 letter "appear to have been addressed." The statement didn't disclose what steps the company had taken to resolve the issues.

Besides Impella, Abiomed makes several other devices to boost circulation in weak hearts or temporarily take over pumping so the heart has a chance to recover.

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