Bracco: CardioGen Back in Early 2012

Bracco Diagnostics expects a “limited and progressive reintroduction” of its CardioGen-82 PET tracer in the first or second quarter of 2012, the company said in an Oct. 17 letter to customers.

The company voluntarily recalled the rubidium-82 generator in July when the U.S. Food and Drug Administration recommended its use be halted because of possible strontium isotopes “breaking through” in the generation process.

The company has been evaluating patients given CardioGen-82 rubidium-82 chloride injections from January through July 2011, and would like all sites administering CardioGen-82 during that time to participate in the study, Bracco officials said.

In conjunction with the voluntary recall, customers were told to return all recalled generators to the U.S. Department of Energy’s Los Alamos National Laboratory for inventory, secure holding and investigation. The evaluation showed that the generators were operating within the specifications for Sr-82 and Sr-85, the company said.

In support of a market return, Bracco is revalidating its manufacturing process and reviewing labeling and user training to ensure proper generator use, the company said. Bracco “has been in constant communication” with the FDA to understand where radiation detected in two patients came from.

The patients’ exposure came to light when they traveled to the United States and set off airport radiation alarms despite having had PET scans two and four months earlier. Rb-82 has a half-life of 75 seconds; strontium’s is 25 days.

The FDA said in July that it believed the risk of harm to be minimal, with the estimated amount of excess radiation the two patients received being similar to that of exposure to certain other types of heart scans.

Bracco officials said the investigation findings continue to point to user error or strontium breakthrough higher than what is expected with normal generator use - or a combination of both.