* Objections over Impella cardiac device marketing
* FDA questions claims in website logo
* Abiomed shares fall almost 5 percent
WASHINGTON, June 28 Abiomed Inc (ABMD.O) is making marketing claims about its heart pump without required clearance or approval, U.S. health regulators said in a warning letter to the company.
Abiomed shares were down almost 5 percent in morning trading on Tuesday after the letter was posted on the website of the Food and Drug Administration.
The FDA, in the letter dated June 10, objected to various claims the company made about the use of the Impella Recover LP 2.5 heart pump and its effectiveness that were unsupported by studies or were not cleared by the FDA.
Among such claims was Abiomed's tagline "Recovering Hearts. Saving Lives." that appears prominently on its website. The FDA said the claim requires a randomized clinical study to evaluate the device's ability to save heart tissue and muscle.
The FDA asked Abiomed to stop marketing the device for the unapproved uses until it receives necessary approval.
The company's spokeswoman, Aimee Maillett, said Abiomed is "working with the FDA to ensure all of our promotional materials comply with the agency moving forward."
The regulators said they had previously sent a warning letter to Abiomed addressing inappropriate marketing claims about the device in January 2010.
The FDA posted the latest letter at: here
The Impella pump is used to improve blood flow in heart failure patients. It has been approved for use in some cases when patients need partial circulatory support. (Reporting by Alina Selyukh, editing by Dave Zimmerman)