Shares of Abiomed Inc. (NSDQ:ABMD) slipped nearly five percent on Wall Street this morning, after the FDA posted a warning letter admonishing the heart pump maker for marketing a device for uses it’s not cleared for.
The federal watchdog agency said a May 12 review of Danvers, Mass.-based Abiomed’s advertising, product labels and website “indicate that Abiomed is making claims that we stated were inappropriate in a January 28, 2010, letter to your firm” about its Impella Recover LP 2.5 cardiac assist device.
“These claims represent a major modification to both the intended use and the indications for use of the device,” according to the missive.
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Abiomed spokeswoman Aimee Maillet told MassDevice that the FDA’s letter addresses promotional materials the company used last year and has since dropped.
“We are working with the FDA to address the issues, but have since ceased the specific promotional items from 2010,” Maillet wrote in an email. “We are working with the FDA to ensure all of our promotional materials comply with the agency moving forward.”
Abiomed won 510(k) clearance for the device, which is inserted via catheter into the heart to help it function, “for ‘partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Recover LP 2.5 also provides pressure measurements which are useful in determining intravascular pressure,'” according to the FDA.
But the company touted the device for uses outside that clearance, specifically for comparing the Impella to treatment with an intra-aortic balloon pump, which the agency said it warned Abiomed not to do in the January letter.
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The FDA also chastised the company for claiming that the device helps improve hemodynamics and cardiac output in heart attack patients, thereby reducing mortality rates.
“Both of these indications would need to be supported with an appropriately designed clinical study performed under an Investigational Device Exemption,” the agency wrote.
And a tagline found on the Abiomed website and in a print ad, “Recovering Hearts, Saving Lives,” amounts to “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,” according to the letter.
ABMD shares were trading at about $15.62 around noon today, down 4.9 percent.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
