FDA Warns Abiomed over Heart Pump Marketing

FDA Warns Abiomed over Heart Pump MarketingThe U.S. Food and Drug Administration recently sent a warning letter to Abiomed claiming it is making marketing claims about its heart pump without having approval from the federal agency, according to Reuters.

The news source reports that in the letter, which was dated June 10, the FDA disputed some of the claims made by Abiomed regarding its Impella Recover LP 2.5 heart pump. The FDA said claims to the effectiveness of the product had not been supported by studies or the agency itself.

One of the claims objected to by the FDA was the "Recovering Hearts. Saving Lives." line on the company's website, which the federal agency said needs to be supported by clinical trials. As such, the FDA asked the company to stop marketing the product for the unapproved uses until it is given the appropriate approval.

Aimee Maillett, a spokeswoman for the company, said that Abiomed is "working with the FDA to ensure all of our promotional materials comply with the agency moving forward," reports Reuters.

Abiomed is headquartered in Danvers, Massachusetts, according to the company's website.