Abiomed, a healthcare products manufacturer based in Danvers, Massachusetts, edged up 3% in morning trading following the closeout of a 2011 warning letter from the United States Food and Drug Administration. The company received the warning letter in response to its marketing practices surrounding the Impella heart pump.

According to information from the company, Abiomed received the good news on February 19th. The FDA closeout letter stated that the federal watchdog agency had “completed its evaluation of the corrective actions taken by Abiomed.” The closeout letter also stated that all concerns in the warning letter had been addressed by the company.

When Abiomed first received the warning letter on June 10th of 2011, shares of the company dropped 5% in intraday trading. The original warning letter was sent due to concerns over marketing materials the company had created in 2010. According to the original letter, the FDA believed that the company’s website and product labels "indicate that Abiomed is making claims that we stated were inappropriate in a January 28, 2010, letter to [Abiomed].” The original warning continued, "These claims represent a major modification to both the intended use and the indications for use of the device.”

While this is a positive development for the company, all is not well at Abiomed. The company is currently facing an investigation from the United States Department of Justice. In addition, the company is currently under an FDA panel vote to determine if its Impella device needs to go through a more-stringent regulatory approval process.

References

www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm260341.htm