* 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:
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)