Abiomed (NSDQ:ABMD) shares opened up today and rose some 3% this morning after the medical device company said late yesterday that the FDA closed out a 2011 warning over the marketing of its Impella heart pump.
The Danvers, Mass.-based company said it received the closeout letter Feb. 19 stating that the FDA’s compliance office "completed its evaluation of the corrective actions taken by Abiomed" and that "the concerns cited in that letter appear to have been addressed."
The original warning letter, from June 10, 2011, initially sent ABMD share prices down 5%.
ABMD shares opened today at $13.99, trading as high as $15 apiece before falling to $14.08 as of about 11:45 a.m., down 0.3%.
Abiomed spokeswoman Aimee Genzler* told MassDevice in 2011 that the FDA’s June 10 letter that year addressed 2010 promotional materials the company had since dropped.
"We are working with the FDA to address the issues, but have since ceased the specific promotional items from 2010," Genzler told us back then. "We are working with the FDA to ensure all of our promotional materials comply with the agency moving forward."
Abiomed did not respond to a request for comment this morning.
In the initial warning letter, the federal watchdog agency said a review of 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 the company’s 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 warning letter.
It’s some badly needed good news for Abiomed, which is also facing a U.S. Justice Dept. probe that’s also believed to center around marketing practices for the Impella device. That overhang has pared some 29% from ABMD shares since Oct. 31, 2012.
Abiomed CEO Michael Minogue told analysts earlier this month that its cardiologist customers are more concerned with outcomes than with the "noise" surround the DoJ investigation and an FDA panel vote that the Impella device be subject to uts more-stringent pre-market approval process.
*Correction, Feb. 21, 2013, 2011: This article originally mis-spelled Mrs. Genzler’s last name. We apologize for the error. Return to the corrected sentence.
